The Effectiveness of the Feldenkrais Method in Reducing Pain and Improving Functionality in Patients With Chronic Neck Pain
Phase: NA
Conditions: Neck Pain
Sponsor: University of West Attica

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University of West Attica 
Health and Care Sciences 
Department of Physiotherapy 
  
  
Date: 22/04/2025  
  
  
Study Protocol and Statistical Analysis Plan 
  
  
“The Effectiveness of the Feldenkrais Method in Reducing Pain 
and Improving Functionality in Patients with Chronic Neck Pain” 
 
                     
 
 
 
 
 
                   
  

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1. INFORMED CONSENT FORM ...................................................................................... 4 
2. FINAL CONFIGURATION OF RESEARCH PROTOCOL ............................................ 6 
2.1. PURPOSE ............................................................................................................. 6 
2.2. RESEARCH DESIGN .......................................................................................... 6 
2.3. RESEARCH  RESEARCH HYPOTHESISES ..................................................... 6 
2.4. OBJECTIVE GOALS ......................................................................................... 12 
2.5. MATERIAL AND METHOD ............................................................................. 12 
2.5.1. SAMPLE ................................................................................................... 12 
2.5.1.1. SAMPLE CHARACTERISTICS ..................................................... 12 
2.5.1.2. METHOD OF RANDOMIZATION AND BLINDING ................... 13 
2.5.1.3. CONDUCT OF RESEARCH - STATEMENT OF CONSENT........ 14 
2.5.1.4. SAMPLING ...................................................................................... 14 
2.5.1.5. INCLUSION CRITERIA .................................................................. 15 
2.5.1.6. EXCLUSION CRITERIA ................................................................. 15 
2.5.1.7. PERSONAL DATA AND DEMOGRAPHIC 
CHARACTERISTICS ................................................................................... 17 
2.5.2. INTERVENTION GROUPS ..................................................................... 18 
2.5.2.1. GROUP A ATM (FM) ....................................................................... 18 
2.5.2.2. GROUP Β A-S .................................................................................. 22 
2.5.3. OUTCOME MEASURES ........................................................................ 24 
2.5.3.1. PRIMARY OUTCOME MEASURE ................................................ 25 
2.5.3.1.1. PAIN SENSITIVITY (PRESSURE ALGOMETER) ................ 25 
2.5.3.2. SECONDARY OUTCOME MEASURES ....................................... 26 
2.5.3.2.1. CERVICAL RANGE OF MOTION (INERTIAL SENSOR) ... 26 
2.5.3.2.2. ENDURANCE OF THE DEEP CERVICAL FLEXORS27 
MUSCLES (PRESSURE BIOFEEDBACK UNIT) ................................. 27 

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2.5.3.2.3. RESPIRATORY FUNCTION (SPIROMETER) ....................... 28 
2.5.3.2.4. INTENSITY AND QUALITY OF PAIN (SHORT-FORM 
28McGill PAIN QUESTIONNAIRE / SFMPQ) ...................................... 28 
2.5.3.2.5. NECK DISABILITY (NECK DISABILITY INDEX / NDI) ... 29 
2.5.3.2.6. ANXIETY AND DEPRESSION (HOSPITAL ANXIETY AND 
29DEPRESSION SCALE / HADS) .......................................................... 29 
2.5.3.2.7. KINESIOPHOBIA (TAMPA SCALE KINESIOPHOBIA / 
TSK) .......................................................................................................... 30 
2.5.3.2.8. FEAR AND AVOIDANCE OF PAIN (FEAR- AVOIDANCE 
30BELIEFS QUESTIONNAIRE / FABQ) ............................................... 30 
2.5.3.2.9. PAIN CATASTOPHIZING (PAIN CATASTOPHIZING SCALE 
/ PCS) ........................................................................................................ 31 
2.5.3.2.10. QUALITY OF LIFE (SF- 12 HEALTH SURVEY / SF-12) ... 31 
2.5.3.2.11. CHANGE OF HEALTH CONDITION (GLOBAL32 
PERCEIVED EFFECT / GPE) ................................................................. 32 
2.6. COMPLIANCE RATE ....................................................................................... 32 
2.7. COMPLAINT FORM ......................................................................................... 33 
2.8. PROCEDURE ..................................................................................................... 33 
2.9. STATISTICAL ANALYSIS ................................................................................ 34 
2.10. RESULTS.......................................................................................................... 35 
2.11. DISCUSSION ................................................................................................... 35 
2.12. CONCLUSIONS-CLINICAL IMPLICATIONS .............................................. 36 
3. REFERENCES ................................................................................................................ 37 
 
  
  
  
  

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1. INFORMED CONSENT FORM  
The final research proposal of the study has been submitted and approved 
both by the main body that concerns it, which is the University First Anesthesiology 
Clinic and the Pain Department of the Aretaeio hospital (Approval No. 263/12-11-
2020) (Document 1), as well as by the Research Ethics and Ethics Committee of the 
University of West Attica (UNIWA), with protocol number: 103276/18-12-2020 
(Document 2).  
 
  
Document 1. Decision by the Research & Ethics Committee of  
 
  
Aretaeio Hospital  

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Document 2. Decision by the Research Ethics and Ethics  
Committee of the University of West Attica (UNIWA)  
 
 
  

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2. FINAL CONFIGURATION OF RESEARCH PROTOCOL  
2.1. PURPOSE  
The present study was designed to examine whether and to what extent the 
application of the Awareness Through Movement (ATM) technique of the 
Feldenkrais method (FM) will reduce pain, improve functionality and will positively 
affect psychological parameters in patients with chronic neck pain, both as a single 
intervention (1st arm) and compared to a protocol of biomedical acupuncture 
combined with stretching (A-S) (2nd arm).  
2.2. RESEARCH DESIGN  
The present study is a single blind randomized controlled clinical trial with an 
active control element, where the intervention is the ATM technique and the standard 
treatment given to the control group is the combination of A-S.  
2.3. RESEARCH HYPOTHESISES  
 Two main research questions are formulated regarding the effectiveness of 
ATM versus a standard treatment regimen consisting of acupuncture and stretching, 
but also the effectiveness of ATM as monotherapy, which will be investigated through 
appropriate statistical controls. The formal basis of statistical tests is the null 
hypothesis under which there is no association between the exposure and the 
outcome (Killeen, 2005). Starting from the assumption of no relationship, statistical 
tests quantify the probability that the observed relationship was observed by chance, 
due to the random sampling distribution. When the null hypothesis cannot be 
rejected then the observed relationship is attributable to chance rather than a true 
effect of the exposure on the outcome (Banerjee et al., 2009).  
Thus, the null hypotheses to be tested are formulated as follows:  
- 
Research question 1: Effectiveness of ATM (intervention group before the 
intervention vs. the same group after the intervention)  
• 
Null hypothesis H0A1: The application of ATM does not affect the pain 
sensitivity assessed by the Pain Pressure Threshold (PPT) measured 

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with the pressure algometer (Commander Algometer) in patients with 
chronic neck pain (main hypothesis).  
• 
Null hypothesis H0A2: The application of ATM does not affect the 
cervical range of motion (ROM) recorded with the Moover 
threedimensional (3D) Inertial Motion sensor in patients with chronic 
neck pain (secondary hypothesis).  
• 
Null hypothesis H0A3: The application of ATM does not affect the 
strength of deep neck flexor muscles as measured by the 
Chattanooga Stabilizer Pressure Biofeedback in patients with chronic 
pain in the cervical spine (secondary hypothesis).  
• 
Null hypothesis H0A4: The application of ATM does not affect the 
respiratory function assessed by the portable spirometer (MIR 
Spirodoc) in patients with chronic neck pain (secondary hypothesis).  
• 
Null hypothesis H0A5: The application of ATM does not affect the pain 
in the cervical spine in terms of its intensity and quality, i.e., its sensory, 
emotional and behavioral dimensions using the McGill Pain 
Questionnaire-short form (SFMPQ) in patients with chronic neck pain 
(secondary hypothesis).  
• 
Null hypothesis H0A6: The application of ATM does not affect the 
functionality recorded with the Neck Disability Index (NDI) in patients 
with chronic pain in the cervical spine (secondary hypothesis).  
• 
Null hypothesis H0A7: The application of ATM does not affect the 
anxiety and depression captured by the Hospital Anxiety & Depression 
Scale (HADS) in patients with chronic neck pain (secondary 
hypothesis).  
• 
Null hypothesis H0A8: The application of ATM does not affect the 
kinesiophobia as measured by the Tampa Scale Kinesiophobia 
(TSK_GR) in patients with chronic neck pain (secondary hypothesis).  
• 
Null hypothesis H0A9: The application of ATM does not affect the 
perception of the fear and the effort to avoid pain in relation to physical 
and work activities assessed by the Fear Avoidance Beliefs 

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Questionnaire_Greek version (FABQ_GR) in patients with chronic 
neck pain (secondary hypothesis).  
• 
Null hypothesis H0A10: The application of ATM does not affect the 
degree of pain catastrophizing recorded by the Pain Catastrophizing 
Scale (PCS) in patients with chronic neck pain (secondary 
hypothesis).  
• 
Null hypothesis H0A11: The application of ATM does not affect the 
quality of life as measured by the Short Form 12-item Health Survey 
(SF-12) in patients with chronic neck pain (secondary hypothesis).  
- 
Research question 2: Effectiveness of ATM versus A-S  
• 
Null hypothesis H0B1: The effect of applying ATM does not differ in 
reducing the pain sensitivity (PPT) in patients with chronic neck pain 
from applying A-S (main hypothesis).  
• 
Null hypothesis H0B2: The effect of the application of ATM does not 
differ in the improvement of the cervical ROM in patients with chronic 
neck pain from the application of A-S (secondary hypothesis).  
• 
Null hypothesis H0B3: The effect of applying ATM does not differ in 
improving the strength of deep neck flexor muscles in patients with 
chronic neck pain than applying A-S (secondary hypothesis).  
• 
Null hypothesis H0B4: The effect of the application of ATM does not 
differ in the improvement of the respiratory function in patients with 
chronic neck pain from the application of A-S (secondary hypothesis).  
• 
Null hypothesis H0B5: The effect of the application of ATM does not 
differ in the reduction of pain in terms of its intensity and quality in 
patients with chronic neck pain from the application of A-S (secondary 
hypothesis).  
• 
Null hypothesis H0B6: The effect of the application of ATM does not 
differ in the improvement of functionality in patients with chronic neck 
pain from the application of A-S (secondary hypothesis).  
• 
Null hypothesis H0B7: The effect of the application of ATM does not 
differ in the reduction of anxiety and depression in patients with chronic 

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pain in the cervical spine from the application of A-S (secondary 
hypothesis).  
• 
Null hypothesis H0B8: The effect of the application of ATM does not 
differ from the application of A-S in reducing kinesiophobia in patients 
with chronic neck pain (secondary hypothesis).  
• 
Null hypothesis H0B9: The effect of the application of ATM does not 
differ in the improvement of perception of fear and effort to avoid pain 
in relation to physical and work activities in patients with chronic neck 
pain from the application of A-S (secondary hypothesis).  
• 
Null hypothesis H0B10: The effect of the application of ATM does not 
differ from the application of A-S in reducing pain catastrophizing in 
patients with chronic neck pain (secondary hypothesis).  
• 
Null hypothesis H0B11: The effect of the application of ATM does not 
differ in the improvement of quality of life in patients with chronic pain 
in the cervical spine from the application of A-S (secondary 
hypothesis).  
The alternative hypotheses to be tested are formulated as follows:  
- 
Research question 1: Effectiveness of ATM (intervention group before the 
intervention vs. the same group after the intervention)  
• 
Alternative hypothesis H1A1: The application of ATM affects the pain 
sensitivity assessed by the Pain Pressure Threshold (PPT) measured 
with the pressure algometer in patients with chronic neck pain (main 
hypothesis).  
• 
Alternative hypothesis H1A2: The application of ATM affects the range 
of motion (ROM) recorded with the Moover three-dimensional (3D) 
Inertial Motion sensor in patients with chronic neck pain (secondary 
hypothesis).  
• 
Alternative hypothesis H1A3: The application of ATM affects deep neck 
flexor muscles strength as measured by the Chattanooga Stabilizer 
Pressure Biofeedback in patients with chronic pain in the cervical 
spine (secondary hypothesis).  

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• 
Alternative hypothesis H1A4: The application of ATM affects the 
respiratory function assessed by the portable spirometer (MIR 
Spirodoc) in patients with chronic neck pain (secondary hypothesis).  
• 
Alternative hypothesis H1A5: The application of ATM affects the levels 
of pain in the cervical spine in terms of its intensity and quality, i.e. its 
sensory, emotional and behavioral dimensions using the McGill Pain 
Questionnaire-short form (SFMPQ) in patients with chronic neck pain 
(secondary hypothesis).  
• 
Alternative hypothesis H1A6: The application of ATM affects the 
improvement of functionality recorded with the Neck Disability Index 
(NDI) in patients with chronic pain in the cervical spine (secondary 
hypothesis).  
• 
Alternative hypothesis H1A7: The application of ATM affects the anxiety 
and depression captured by the Hospital Anxiety & Depression Scale 
(HADS) in patients with chronic neck pain (secondary hypothesis).  
• 
Alternative hypothesis H1A8: The application of ATM affects 
kinesiophobia as measured by the Tampa Scale Kinesiophobia 
(TSK_GR) (secondary hypothesis).  
• 
Alternative hypothesis H1A9: The application of ATM affects the 
perception of fear and the effort to avoid pain in relation to physical 
and work activities recorded with the Fear Avoidance Beliefs 
Questionnaire_Greek version (FABQ_GR) in patients with chronic 
neck pain (secondary hypothesis).  
• 
Alternative hypothesis H1A10: The application of ATM affects the pain 
catastrophizing assessed by the Pain Catastrophizing Scale (PCS) in 
patients with chronic neck pain (secondary hypothesis).  
• 
Alternative hypothesis H1A11: The application of ATM affects the   
quality of life captured by the Short Form 12-item Health Survey 
(SF12) in patients with chronic neck pain (secondary hypothesis).  
 
 

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- Research question 2: Effectiveness of ATM versus A-S  
• 
Alternative hypothesis H1B1: The effect of applying ATM differs in 
reducing the pain sensitivity (PPT) in patients with chronic neck pain 
from applying A-S (main hypothesis).  
• 
Alternative hypothesis H1B2: The effect of the application of ATM differs 
in the improvement of ROM in patients with chronic pain in the cervical 
spine from the application of A-S (secondary hypothesis).  
• 
Alternative hypothesis H1B3: The effect of applying ATM differs in 
improving the strength of deep neck flexor muscles in patients with 
chronic neck pain from applying A-S (secondary hypothesis).  
• 
Alternative hypothesis H1B4: The effect of applying ATM differs in 
improving the respiratory function in patients with chronic neck pain 
from applying A-S (secondary hypothesis).  
• 
Alternative hypothesis H1B5: The effect of the application of ATM differs 
in the reduction of pain in terms of its intensity and quality in patients 
with chronic neck pain from the application of A-S (secondary 
hypothesis).  
• 
Alternative hypothesis H1B6: The effect of the application of ATM differs 
in the improvement of functionality in patients with chronic neck pain 
from the application of A-S (secondary hypothesis).  
• 
Alternative hypothesis H1B7: The effect of the application of ATM differs 
in the reduction of anxiety and depression in patients with chronic pain 
in the cervical spine from the application of A-S (secondary 
hypothesis).  
• 
Alternative hypothesis H1B8: The effect of applying ATM differs in 
reducing kinesiophobia in patients with chronic neck pain from 
applying A-S (secondary hypothesis).  
• 
Alternative hypothesis H1B9: The effect of the application of ATM differs 
in the reduction of the perception of fear and effort to avoid pain in 
relation to physical and work activities in patients with chronic neck 
pain from the application of A-S (secondary hypothesis).  

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• 
Alternative hypothesis H1B10: The effect of applying ATM differs in 
improving pain catastrophizing in patients with chronic neck pain from 
applying A-S (secondary hypothesis).  
• 
Alternative hypothesis H1B11: The effect of the application of ATM 
differs in the improvement of the quality of life in patients with chronic 
pain in the cervical spine from the application of A-S (secondary 
hypothesis).  
2.4. OBJECTIVE GOALS  
Objectives of the study are summarized in the investigation of statistically 
significant differences in the outcomes of interest, i.e. in the measurements for pain 
sensitivity, intensity and quality (pressure algometer and SFMPQ), functionality 
(NDI), ROM (Moover 3D Inertial Motion sensor), endurance of deep neck flexor 
muscles (Chattanooga Stabilizer Pressure Biofeedback), respiratory function 
(portable spirometer) and psychological parameters (HADS, TSK, FABQ, PCS, SF-
12). Differences in the outcomes of interest may arise:   
a) 
between the start time (baseline) and the end time of the study within 
the A-ATM group (A-ATM group at baseline versus A-ATM group after the 
intervention).  
b) 
between the compared groups of the clinical trial {group A ATM 
(Intervention Group) versus group B A-S (Active Control Group)}, both at the 
beginning of the study, as well as after the intervention.  
2.5. MATERIAL AND METHOD  
2.5.1. SAMPLE   
2.5.1.1. SAMPLE CHARACTERISTICS   
During the initial calculation of the sample number, the number of the participants 
was determined, with purpose, the method of Analysis of Variance (ANOVA) in two 
groups of equal population, to identify a standardized effect size equal to 0.25 with 
a power of 80% and a level of statistical significance of 5%. The standardized effect 
size is defined as follows: Let the measurement tool X and groups A, B and μA, μB 

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be the mean values of X in groups A and B. SD is the Standard Deviation of X in the 
whole population. The effect size is given by the formula (|μA-μB|)/SD. The 
calculation was performed with the program G*power version 3.1.9.7* and the 
necessary sample size was calculated at 126 subjects. According to the relevant 
literature, similar standardized sample sizes have been used in two studies dealing 
with chronic neck pain (Lundblad et al., 1999; Malmgren-Olsson et al., 2009). 
Moreover, a dropout rate of 20% was expected, so a final number of around 152 
patients is realistic for this study.  
2.5.1.2. METHOD OF RANDOMIZATION AND BLINDING  
The sample will include 152 patients of both sexes and age range 19-70 years. 
Participants will be collected using the simple random sampling method and these 
meeting the inclusion and exclusion criteria will be recruited and will form the study 
sample. The participants will be allocated using the method of simple randomization 
with an allocation ratio of 1:1, i.e. in two equal groups of 76 people, each.  
The randomization of patients to the A ATM group and the B A-S group will be 
performed with the help of a random number generator created in Stata software 
with the help of the “randomizer” package. The “randomizer” package through the 
principles of binomial distribution, randomly assigns to each participant their 
participation in either the intervention group or the active control group. In this way 
each participant will be placed in one of two groups at the start of the study and will 
remain in the same group for the duration of the study. The ratio of subjects between 
the two groups will be maintained at 1:1 throughout the study.  
This study is a single blind clinical trial. The intervention will be perceived by the 
principal researcher, who will apply the treatment protocol in the intervention group 
(A ATM), the physiotherapist, who will apply the treatment protocol in the active 
control group (B A-S) and the participants. It is not feasible for both participants and 
therapists to be blinded, due to the nature of each intervention. All evaluations of the 
effectiveness of the treatment interventions will be carried out by two independent 
assessors who, although belonging to the research team of the study, do not know 
the type of intervention that each patient will receive, as well as the allocation of 
patients to the different treatment intervention groups (Kang, 2013, Opara et al., 

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2013). The first assessor will administer the consent form, the demographic 
characteristics form, the questionnaires and recorded the primary outcome 
measures, as well as the secondary outcome measure prior to the start of the study. 
The second assessor will administer the compliance and complaint form to the 
participants and will record the primary outcome measure and the secondary 
outcome measures after the completion of the interventions. Data analysis will be 
performed by an independent biostatistician, an associate of the Musculoskeletal 
Physiotherapy Research Laboratory of the University of West Attica (UNIWA), who 
will not know the group in which each participant will have been allocated.  
2.5.1.3. CONDUCT OF RESEARCH - STATEMENT OF CONSENT   
 The technique of ATM of the Feldenkrais method will be applied at the “Mikis 
Theodorakis” Multipurpose Center for Cultural, Sports and Social Activities of Ilion 
in Athens, Greece, in collaboration with the Musculoskeletal Physiotherapy 
Research Laboratory of the University of West Attica (UNIWA). The acupuncture 
treatments, the teaching of stretching (which will then be carried out at home) as 
well as the assessment measurements for both interventions will be carried out in 
the clinic pain of the 1st Anesthesiology Clinic of the Aretaeio Hospital, in 
collaboration with the Musculoskeletal Physiotherapy Research Laboratory of the 
University of West Attica (UNIWA). All prospective patients should have a referral 
from their treating physician certifying a diagnosis of non-specific chronic neck pain. 
Before the start of the sessions, a written statement of consent will be given that 
patients agree to participate in the research and that they can stop at any time they 
wish, in accordance with the regulation of the European Union (2016/679) for the 
protection of personal data and the rules of medical confidentiality of the Ethics and 
Ethics Committee of the UNIWA.  
2.5.1.4. SAMPLING  
The sampling of the study will follow the following steps. Starting on July 25, 
2022 and until the required number of people set according to the protocol is 
completed, the doctors of the pain clinic of the 1st Anesthesiology Clinic of the 
Aretaeio hospital will assess all the patients who will come to the outpatient clinics 
and will be diagnosed by them with chronic non-specific neck pain or will have 
already a diagnosis of chronic non-specific neck pain by their treating physician. The 

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assessment of the patients will be carried out according to the inclusion and the 
exclusion criteria that will be defined in this study.  
2.5.1.5. INCLUSION CRITERIA  
The selection of the sample will be based on the criteria listed in the following 
table (Table 1).  
Table 1. Patient inclusion criteria  
 
1. Diagnosis of chronic non-specific neck pain.  
2. Duration of the symptoms at least three months before the initial 
assessment and their participation in the study.  
3. Age range 19-70 years.  
 
  
2.5.1.6 EXCLUSION CRITERIA  
Initially, a clinical examination-diagnosis of chronic non-specific neck pain will 
be carried out by the attending physician and then, the cases that do not meet the 
above inclusion criteria or meet at least one of the exclusion criteria listed in the 
following table (Table 2), will be excluded. The remaining patients will complete the 
consent form. Chronic non-specific neck pain refers to pain that is not due to a 
specific pathology or anatomical abnormalities. Therefore, the diagnosis will result 
from the exclusion of an identified or serious condition. The symptoms resemble 
those of Whiplash Associated Disorders (WAD) grades I and II, with the difference 
that the latter result from a traumatic event (Tsakitzidis et al. 2013). It should be 
noted that Table 2 also lists situations that constitute "red flags".  
 
 
 
 
 
 
 

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Table 2. Patient exclusion criteria  
1. History of surgical intervention in the cervical spine (Dibai - Filho et al., 2017).  
2. History of neck fracture or injury (Campa - Moran et al., 2015; Dibai - Filho et al., 
2017) in the last year.  
3. Head, face or neck surgery (Dibai - Filho et al., 2017)  
4. Active cervical hernia with radicular symptoms or severe degenerative diseases 
in the cervical spine (Dibai - Filho et al., 2017)  
5. Systemic diseases (diagnosed rheumatic, metabolic and immunological 
diseases) (Edwards & Knowles, 2003; Wilke et al., 2014; Campa - Moran et al., 
2015; Cerezo - Téllez et al., 2016; Dibai - Filho et al., 2017; Cerezo - Téllez et 
al., 2018)  
6. Myelopathy with severe disc or bone damage (Ma et al., 2010; Campa - Moran 
et al., 2015)   
7. Cervical radiculitis/radiculopathy (Ma et al., 2010; Wilke et al., 2014; Campa - 
Moran et al., 2015)  
8. Arterial dysfunction (Kerry et al., 2008)    
9. Neoplasms active during the last five years  
10. Lymphadenopathy (Tsakitzidis et al., 2013)  
11. History of inflammatory arthritis (Tsakitzidis et al., 2013)  
12. Diagnosed psychiatric illness (Wilke et al., 2014; Cerezo - Téllez et al., 2016;  
Cerezo - Téllez et al., 2018)  
13. Severe neurological disorder (Edwards & Knowles, 2003; Wilke et al., 2014) or 
mental retardation (Ma et al., 2010)  
14. Signs, symptoms or history of oral pain and temporomandibular disorders based 
on the Research Diagnostic Criteria of Temporomandibular Disorders -  
RDC/TMD (Campa - Moran et al., 2015)  
15. Fibromyalgia syndrome (Ma et al., 2010; Wilke et al., 2014; Cerezo -Téllez et 
al., 2016; Cerezo - Téllez et al., 2018)  
16. Infection or inflammatory swelling in the treated area  
17. Skin damage (Edwards & Knowles, 2003) or wounds in the puncture area  

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(Cerezo - Téllez et al., 2016; Cerezo - Téllez et al., 2018)  
18. Systemic intake of drugs that may affect the patient's judgment, (e.g.  
neuromodulators, antidepressants)  
19. Taking systemic treatment for the same problem (Wilke et al., 2014) up to three 
months before the study  
20. Pregnancy (Cerezo - Téllez et al., 2016; Cerezo - Téllez et al., 2018)  
21. Previous adverse reaction to acupuncture (Edwards & Knowles, 2003)  
22. Metal allergy (Cerezo - Téllez et al., 2016; Cerezo - Téllez et al., 2018)  
23. Fear of needles (Edwards & Knowles, 2003; Campa - Moran et al., 2015;  
Cerezo - Téllez et al., 2016; Cerezo - Téllez et al., 2018)  
24. Inability to express speech and writing in the Greek language  
  
  
Participants who will agree to undergo the interventions, will fill out the 
demographic characteristics form and the questionnaires.  
2.5.1.7. PERSONAL DATA AND DEMOGRAPHIC CHARACTERISTICS  
The personal data that will be collected from each participant will be kept 
anonymous. Personal information, that can be used to identify the participant, at no 
stage of data collection will be requested, to protect their personal data inviolably. 
The above will be achieved with the help of pseudonymization and generalization of 
information that could link a pseudonym with some exclusive characteristic. For 
example, if the subject recorded as "Respondent 1" is 37 years old, their age is not 
recorded, but their age group (35-40). The procedure will be performed by a 
biostatistician, associate of the Musculoskeletal Physiotherapy Laboratory of 
UNIWA. In addition, the technique of file encryption will be followed using VeraCrypt 
Containers (Bursać et al., 2017), i.e. the data will be placed inside a virtual disk file 
that with the use of "encryption keys" and the algorithm AES-256 will be converted 
into an unintelligible format so that they cannot be read by researchers, only by the 
owner of the encryption keys (biostatistician) (Loukas, 2017), protecting them during 
computer operation, even when they are not in use. The computer that will be used 
to store and process the data will be provided with a password, an encrypted hard 

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disk to protect data at rest, from anti-electronic threat software. Moreover, the 
computer will be isolated in the Musculoskeletal Physiotherapy Laboratory and will 
not have access to the internet. This data will be stored on a computer that has been 
assigned a password known only to the main researcher. They will remain 
confidential throughout the interventions and after five years the RAM and hard drive 
of the computer containing all the material and/or information collected from the 
research will be destroyed, exposing them to microwaves and causing them to wear 
naturally (e.g., drill holes). All physical records that have been collected (e.g., 
questionnaires) will be destroyed in a special document shredder.  
The demographic characteristics form includes information regarding the 
participant's gender, age range, body measurements (weight, height), educational 
level, employment status, and field of employment. In addition, it contains 
information on marital status, duration of symptoms, medication, and the presence 
of other medical condition, except for chronic non-specific neck pain. Regarding 
medication as well as the presence of another medical condition, they refer to drugs 
and diseases that are not included in the exclusion criteria.  
2.5.2. INTERVENTION GROUPS   
2.5.2.1. GROUP A ATM (FM)  
 ATM involve a series of structured verbally guided motor activities usually 
conducted in the form of group lesson sessions. The lessons are based on the 
developmental sequence and vary in the level of difficulty from relatively complex, 
applied to people with physical impairments to hypercomplex addressed to those 
with high motor requirements. The duration of each lesson varies between 30-60 
minutes. In the beginning, simple, comfortable, gentle movements are performed 
that will gradually develop into complex ones, with a self-determined manner and 
rhythm by the trainee. The purpose is the teaching of execution rather than the 
completion of the movement. The improvement of awareness and the organization 
of the body is caused through the verbal instructions-orders or questions-problems 
that is posed by the educators of the method. The above aims at implementing a 
sequence of movements and focusing on different parts of the body (internal 
feedback). A corollary to this is the empathy of basic functions. Each lesson that will 

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be included in the protocol of the ATM group, will have a specific request and topic, 
while it will be organized around a functional activity.   
ATM affects muscle tone, reduces tension and unnecessary effort, aiming at 
improving the sensorimotor perception. The latter induces the absolute regulation of 
movements by the trainees. Among the goals is to increase awareness regarding 
the mechanics of movements. Through the technique, the suspension of 
stereotyped movement patterns, the expansion of movement options, the learning 
of new movements and the presentation of a new way of composing them are 
attempted. A crucial role for the achievement of the aforementioned is played by the 
reduction of mental tension, which is caused by encouraging less effort to be exerted 
each time during the movement. Correcting incorrect moves goes against the 
philosophy of the method that supports inquiry learning.   
According to the philosophy of FM, the treatment of chronic neck pain 
requires an approach from the perspective of other components besides the cervical 
spine. In this light, neck pain can originate from the neck but also from other causes, 
including inadequate breathing patterns, pelvic tilts, insufficient differentiation of eye 
or head movements, overuse of the upper extremity musculature. An inseparable 
relationship is detected between the neck and the temporomandibular joint, i.e. the 
incorrect position of the former affects the function of the latter and conversely the 
increased tension in the temporomandibular joint changes the muscle tone of the 
neck. This category also includes the limited movement of the lumbar spine as well 
as the injury of the end of the foot that disrupts the smooth functioning of the 
biokinetic chain (Plastaras et al., 2011).  
In the A ATM group (intervention group) the ATM technique will be applied in 
group sessions (6-8 patients) by a physiotherapist, specialized in the FM with at 
least five years of experience. The ATM protocol will be implemented in ten sessions, 
two per week, of 50 minutes each, for a period of 5 weeks.   
On the remaining days, home exercises will be given to the patients in the 
form of printed illustrated instructions for their correct execution. These ATM 
exercises, will be a repetition of the ATM lesson that they will have been taught and, 
will be performed once a day, until the next session, where participants will learn 

20  
  
and implement the next ATM lesson. The execution rate of the movements and the 
movement pattern will be individualized, as they dependent on each patient.  
In this protocol ten ATM-sessions will be conducted, which are derived from 
original courses taught by Moshe Feldenkrais and each of them will address a 
specific function within the developmental repertoire. In details, the first, "Rolling the 
fists", will aim at the connection between upper limbs and spine. The second, 
"Stomach and chest first" will activate the diaphragm. The third, "Hip and Shoulder 
Integration" is the first approach to shoulder differentiation. The "The Movement of 
the Eyes Organizes the Movement of the Body" helps control the functional 
connections between the eyes and neck muscles. The "Skewering the spine in the 
chest" will promote the movement of the spinal chain and is a continuation of the 
logical choice of "Rolling the fists" with the difference that it aims at the greater range 
of activation of the central point of the body, connecting the trunk with the upper 
limbs. The «On the back; twisting the spine with the head fixed» will improve rotation 
by changing the relationship between the proximal (below the A7 vertebra) and distal 
cervical spine parts of the spine. The "A clock in front of the face" will enhance the 
shoulder-head and spine differentiation. The "Breathing (To weld by breathing)" will 
increase the volume and flexibility of the rib cage. Τhe «Edges of the feet» will help 
to the connection of the ankle joints with the hip joints and through them with the 
spine and head. Finally, the "On the side, the sternum becoming flexible" will 
mobilize the sternum in order to improve the rotation and extension of the neck. The 
above lessons have been translated and modified by the main researcher following 
a specific format as a methodological aid for their reading and understanding.  
Below is a summary table of the ATM courses in the order they will be held 
(Table 3).  
   
 
 
 
 
 
   

21  
  
Table 3. Awareness Through Movement (ATM) Lessons  
 
1ο: Rolling the fists  
Source: ATM Lesson from Alexander Yanai #68 (Feldenkrais 1995a)  
2ο: Stomach and chest first  
Source: ATM Lesson from Alexander Yanai #35 (Feldenkrais 1995b)  
3o: Hip and Shoulder Integration  
Source: San Francisco Evening Class, Volume 1, Lesson 7 (Feldenkrais 1980)  
4ο: The Movement of the Eyes Organizes the Movement of the Body  
Source: Lesson 10 from ATM Book (Feldenkrais 1990)  
5ο: Skewering the spine in the chest  
Source: ATM Lesson from Alexander Yanai Lesson #308 (Feldenkrais 2000)  
6ο: On the back; twisting the spine with the head fixed  
Source: ATM Lesson from Alexander Yanai #110 (Feldenkrais 1995c)  
7ο: A clock in front of the face  
Source: ATM Lessons from Alexander Yanai #82 (Feldenkrais 1995d)  
  
8ο: Breathing (To weld by breathing)  
Source: ATM Lesson from Alexander Yanai #179 (Feldenkrais 1997a)  
9ο: Edges of the feet  
Source: ATM Lesson from Alexander Yanai #433 (Feldenkrais, 2001)  
10ο: On the side, the sternum becoming flexible  
Source: ATM Lesson from Alexander Yanai #217 (Feldenkrais 1997b)  
 
 
 
 

22  
  
6.5.2.2. GROUP Β A-S  
In the B A-S group (active control group) before the implementation of the A-
S protocol, a complete musculoskeletal assessment of the patients by an 
experienced physiotherapist trained in the identification of MTrPs, will be applied. 
The MTrP identification will be achieved by palpation of the muscles under 
examination (upper trapezius, levator scapulae, splenius capitis and cervicis), 
according to the criteria of Travell and Simons (1992). The points identified will be 
marked with indelible ink and recorded on a pain diagram. The patients’ skin will be 
cleaned with alcohol before the acupuncture.  
The A-S protocol will be performed in ten individual sessions, two per week, 
of 40 minutes each, for a period of 5 weeks. Acupuncture will be performed for 25 
minutes by an experienced and licensed physiotherapist. It will include the insertion 
of a sterile disposable needle of 0.25 mm diameter and 25 mm length (DongBang 
Acupuncture, Inc., Korea) into standardized as possible appropriate local, regional 
and general points, that will modify the behavior of the pain in the area of the Cervical 
Spine.  
Local acupoints will include:  
• 
Small Intestine 14 (SI 14) which is located 3 Cun (1 Cun = maximum 
width of the patient's thumb) lateral to the lower border of the spinous 
process of the first thoracic vertebra (T1) (Sun et al., 2019) and is a 
common MTrP in the levator scapulae muscle.  
• 
Gallbladder 21 (GB 21) which is located at the midpoint of the line 
connecting the acromion with the spinous process of the seventh 
cervical vertebra (A7) (Wilke et al., 2014; Sun et al., 2019) and is a 
common MTrP in the upper trapezius muscle.  
• 
Gallbladder 20 (GB 20) which is below the occipital, in the depression 
between the insertions of the sternocleidomastoid and the trapezius 
muscles (Wilke et al., 2014; Sun et al., 2019).  
• 
Bladder 43 (BL 43) which is located at the same height with the upper 
limit of the spinous process of the fourth thoracic vertebra (T4), 3 Cun 
lateral to the midline (Wilke et al., 2014).  
  

23  
  
Regional acupoints will include:  
• 
Huato Jiaji C5 which is located paraspinal at the level of the fifth 
cervical vertebra (A5).  
• 
Bladder 10 (BL 10) which is located on the horizontal line, passing 
between the spinous processes of the first (A1) and the second (A2) 
cervical vertebra and the oblique line, passing through the outer limit 
of the upper trapezius muscle, 1.3 Cun bilaterally of the vertical axis 
of the body, passing through the spinous processes of Α1-Α2 (Wilke 
et al., 2014; Sun et al., 2019).  
• 
Governing Vessel 14 (GV 14) in the depression, inferior to the spinous 
process of the seventh cervical vertebra (A7) (Karavis, 2011; Wilke et 
al., 2014).  
General acupoints will include:  
• 
Triple Energizer 5 (TE 5) which is located 3 cm above the joint line of 
the wrist, at the dorsal surface of the forearm between the radius and 
ulna (Wilke et al.,2014; Calamita et al., 2018)   
• 
Large Intestine 4 (LI 4) in the hollow of the radial side of the hand, 
approximately at the midpoint of the 2nd metacarpal.   
After the needle will be removed, firm compression will be applied to the 
injection sites for 40 seconds to prevent any microbleeding (Campa - Moran et al., 
2015). The protocol acupoints are listed in Table 4.  
  
Table 4. Biomedical acupuncture protocol points  
Local  
Regional  
General  
SI 14 (MTrP in the levator 
scapula muscle)  
GB 21 (MTrP in the upper 
trapezius muscle)  
GB 20   
BL 43   
  
Huato Jiaji C5  
BL 10  
GV 14  
  
TE 5  
LI 4  
  
  

24  
  
Potential events, except for dermatitis, will be managed in accordance with 
the "Management of Adverse Reactions to Acupuncture and Dry Needling" section 
of the Guide to Safe Acupuncture and Use of dry needling of the World 
Confederation of Physical Therapy (WCPT) and the special subgroup dealing with 
acupuncture (International Acupuncture Association of Physical Therapists – 
IAAPT). In the event of dermatitis after the application of acupuncture, a wet towel 
or cloth can be applied to the affected area, followed by a cream or ointment 
containing calcineurin inhibitors or a corticosteroid cream, gel or ointment. The 
affected skin can be subjected to phototherapy, i.e., controlled amounts of natural or 
artificial light (Dermatitis, 2020). If symptoms persist, the patient should be referred 
to their treating physician. It is pointed out that the side effects result from improper 
sterilization and use of the needles (Sfara, 2013). White (2004) estimated the risk of 
a serious adverse event to be 0.05/10.000 treatments and 0.55/10.000 patients.  
The 15-minute stretching will also follow a pre-planned application and 
explanation process and will be as systematic as possible for patients. They will be 
performed at home, once a day, after prior instruction by the same physical therapist. 
Stretching will be applied to the following muscles: upper trapezius, levator 
scapulae, scalene, cervical extensors (splenius, spinalis, semispinalis, longissimus 
capitis and cervicis, iliocostalis cervicis, multifidi and suboccipital), and 
sternocleidomastoid. According to Hӓkinnen et al., the duration of each stretch will 
be 30 seconds and will be repeated three times (Häkkinen et al., 2007), with one 
minute rest in between sets and ten seconds rest between each try.  
2.5.3. OUTCOME MEASURES  
Primary outcome measures will be the sensitivity of pain and secondary 
outcome measures will be the ROM of flexion, flexion-extension and lateral flexion 
of the cervical spine, the endurance of the deep flexor muscles of the cervical spine, 
the respiratory function, the intensity as well as the sensory and affective dimensions 
of the pain, the functional capacity of the neck, the anxiety and depression, the fear 
of movement, the perception of fear and the attempt to avoid pain in relation to 
physical and work activities, the degree of destructive views about pain, the quality 

25  
  
of life and patients’ perceived change in their health conditions. Furthermore, the 
compliance rate will be recorded.  
The measuring tools were selected based on their validity, reliability, ease of 
application and clinical economy. The outcome measures were assessed before the 
start as well as at the completion of the therapeutic interventions at five weeks, for 
both groups.  
2.5.3.1. PRIMARY OUTCOME MEASURE  
2.5.3.1.1. PAIN SENSITIVITY (PRESSURE ALGOMETER)  
The primary outcome measure will be the pain sensitivity and a pressure 
algometer (Commander® Algometer, JTECH Medical, Midvale, Utah) will be used, 
measuring the Mechanical Pain Threshold (MPT). This model is a handheld 
algometer with two different heads (with surface of 0.5 cm2, 1 cm2), a flat pad and a 
fingertip adapter. The maximum input force reaches 111 N, while the wireless radio 
frequency (RF) reaches 2.4 GHz. The head which will be used has an area of one 
square centimeter (1cm²) and the unit of measurement for the MPT value is kilogram 
per square centimeter (kg/cm2).  
In this PhD thesis, the recording of the pain sensitivity will be performed at 
specific points such as the upper part of the trapezius muscle and the suboccipital 
region, as the pressure algometer has shown high intra-rater reliability when applied 
to the upper trapezius muscle (Intraclass Correlation Coefficient / ICC:  0.85-0.86) 
and the suboccipital region (ICC: 0.84-0.93) in patients with chronic non-specific 
neck pain (Pérez-Martínez et al., 2020). The measurement in the suboccipital region 
will be performed at the mastoid process and at the BL 10 point, which is located on 
the horizontal line that passes between the spinous processes of the C1 and C2 
vertebrae and the oblique line that passes through the outer border of the upper part 
of the trapezius muscle. It is exactly 1 cm on either side of the vertical axis of the 
body, which passes through the spinous processes of the C1 and C2 vertebrae. In 
the upper trapezius muscle, the measurement point is between the midline and the 
lateral border of the acromion (Wang-Price et al., 2019). In addition, measurements 
will be made at the zygopophyseal joint between C5-C6 intervertebral space (1/2 

26  
  
Cun), at the tibialis anterior muscle (Stomach 36/ST 36), at the middle part of the 
deltoid muscle (1-2 cm below the acromion) as well as in the levator scapula muscle 
(2 cm above its epiphysis, at the upper medial angle of the scapula) (Wang-Price et 
al., 2019).  
Patients will be placed in a prone position (Fischer, 1987) for all 
measurements. At each aforementioned point, three measurements will be taken 
with the possibility of a 30-second break between measurements (Pelfort et al., 
2015). The first measurement will be discarded since it will be considered as a trial. 
The average of the two consecutive measurements (second and third) will be 
calculated and recorded as the final value (Wilke et al., 2014; Pelfort et al., 2015). 
The force that will be applied for the measurements will be perpendicular to the body 
surface and the rate of pressure increase constant at 1 kg/cm2 per second (Reeves 
et al., 1986; Koo et al., 2013), because if it is not constant the possibility of incorrect 
measurement will be increased.  
2.5.3.2. SECONDARY OUTCOME MEASURES  
2.5.3.2.1. CERVICAL RANGE OF MOTION (INERTIAL SENSOR)  
Secondary measurements include range of motion (ROM) of flexion, flexion-
extension and lateral flexion of the cervical spine. It will be recorded using the 
Moover® 3D Inertial Motion Sensor (Sensor medica; Guidonia Montecelio, Roma, 
Italia). This device has dimensions 36×32×12mm and weight 15gr (including the 
battery), allows goniometric evaluation, acceleration and rotation and converts them 
into electrical signal. The accelerometer can record ROM and acceleration values in 
three axes (Thomas et al., 2018). Through the software application, all recorded 
data are converted into diagrams and an automatic report is displayed. It has a 16bit 
resolution, automatic calibration, frequency up to 1000Hz, battery life of six hours 
and the connection is achieved via Bluetooth 3.0.  
The Sensor will be positioned in the center of the forehead on the frontal bone 
at the level of the glabella, which is above the nasal bridge, and it will be fastened 
around the head with the assistance of a strap (Thomas et al., 2018). Then the rater 
will calibrate the device in a standardized neutral body position or starting position. 

27  
  
The patients will be trained through standardized instructions using video-recorded 
movements and commands, to perform cervical movements (left-right rotation, left-
right lateral flexion and flexion-extension) correctly. Patients will perform three full-
ROM movements, in each plane of motion, pausing for one second at the end of the 
ROM. To avoid measurement errors due to trunk compensating movements, active 
stabilization of the trunk and the shoulders will be applied manually by the rater’s 
hands placed over the distal clavicle and acromion region (Fletcher and Bandy, 
2008) while sitting directly behind the subject and passive stabilization will be 
provided by the backrest of the chair. The validity and the reliability of the wearable 
motion sensors in cervical spine have been recorded in the literature (Anoro-Hervera 
et al., 2019; Elizagaray-García et al., 2021).  
2.5.3.2.2. ENDURANCE OF THE DEEP CERVICAL FLEXORS MUSCLES  
(PRESSURE BIOFEEDBACK UNIT)  
The endurance of the deep flexor muscles of the spine will be assessed with 
a pressure biofeedback unit (Chattanooga Stabilizer Pressure Biofeedback). It 
allows physical movements and especially those concerning the spine during 
exercise. The changing pressure will be recorded in an air-filled pressure cell, which 
is connected to a combined guide and plier. It is a device used for joint protection 
and stabilization exercises that contribute to the treatment and prevention of pain in 
the cervical spine or lumbar spine, while it also provides biofeedback to physical 
movements, reducing pain in these areas. The proportional pressure range is 
between 0 mmHg - 200 mmHg with an accuracy of +/−3mmHz (Chattanooga 2020). 
The efficiency index is calculated as the quotient where the numerator records the 
pressure increase in the chamber and the denominator the number of repetitions. 
The maximum applied pressure sustained for a period of ten seconds is defined as 
the degree of activation (Magee, 2018).  
The craniocervical flexion test will be selected as it only evaluates the deep 
neck flexors and not the superficial flexor muscles (Strimpakos et al., 2011). This 
test has intra- rater (ICC: 0.63) and inter- rater (ICC: 0.86) reliability in NSCNP 
patients. Moreover, there is significant correlation between craniocervical flexion test 

28  
  
and NDI (a = −0.40), SF36- Physical Component Summary/PCS (a = 0.56) and NRS 
(a = −0.37) (Jørgensen et al., 2014).  
2.5.3.2.3. RESPIRATORY FUNCTION (SPIROMETER) 
For the evaluation of the respiratory function, a portable spirometer of the MIR 
company (MIR Spirodoc), with dimensions of the central unit and the removable 
head-turbine 101x48x16mm and weight 99g and 46x47x24mm and weight 17g 
respectively, will be used. This measurement tool has an LCD touch screen, a 
rechargeable battery with a 30-hour reserve measurement, a built-in three-axis 
motion recorder (triaxial sensor-3D Oximeter®), while it can be connected to the 
computer either with USB 2.0 or Bluetooth® 2.1. It is indicated for applications in the 
field of rehabilitation, telemedicine and clinical research (Medical International 
Research 2020).  
Portable spirometers are reliable compared to spirometry in a pulmonary 
function laboratory, which is considered as the gold standard. Additionally, has been 
found correlation between measurements performed in the pulmonary function 
laboratory and measurements done by the patient at home on the same day, 
regarding the FVC (ICC: 0.94) and FEV1 (ICC: 0.99) (Finkelstein et al., 1993).  
2.5.3.2.4. INTENSITY AND QUALITY OF PAIN (SHORT-FORM MCGILL PAIN 
QUESTIONNAIRE / SFMPQ)  
Pain will also be assessed subjectively with the SFMPQ questionnaire which 
includes its intensity as well as its sensory and affective dimensions (Melzack 1987). 
It consists of 11 sensory and 4 affective descriptors of pain. The patient rates each 
description on a four-point Likert type intensity scale, where 0 – no pain, 1 – mild 
pain, 2 – moderate pain and 3 – severe pain. SFMPQ also includes a ten-point Visual 
Analogue Scale (VAS) and a six-point rating scale describing the present intensity 
of pain (PPI), where: 0=No pain, 1=Mild, 2 =Annoying, 3=Painful, 4=Horrible, 
5=Unbearable. The total score amounts to 45 points -33 for the sensory subscale, 
12 for the affective subscale, 10 for the VAS and 5 for the PPI- (Neurotoolkit 2020). 
Furthermore, the SFMPQ is comprehensible and can be completed by people of 
different educational levels (even primary school graduates). It is a tool for 
multidimensional assessment of pain in patients with chronic musculoskeletal 
problems (the research sample in the Greek population consisted of patients 

29  
  
experiencing chronic pain with spinal and osteoarthritic conditions) (Georgoudis et 
al., 2000).  
The short form of the questionnaire was translated and validated to the Greek 
population in 2000 by Georgoudis et al. (2000) (the GREEK-SMFPQ/the GR-
SFMPQ). The internal reliability of the Greek version of the SFMPQ has been 
indicated (Cronbach’s α value = 0.71) (Georgoudis et al., 2000). 
2.5.3.2.5 NECK DISABILITY (NECK DISABILITY INDEX / NDI)  
Neck functional capacity will be assessed with the self-reported NDI. The NDI 
captures disability/inability to perform daily activities due to neck pain. It consists of 
ten items, eight of which relate to various activities (personal care, lifting, driving, 
work, sleep, concentration, reading, entertainment) and two to pain in terms of 
intensity parameters and headache. Each item corresponds to six answers from 
which the participant should choose only one, the one that best represents their 
current situation. The lowest score for each item is zero, which is assigned as no 
pain and no functional limitation and the maximum five, which refers to the worst 
pain and maximum limitation. It is therefore understandable that the total score 
ranges from zero to fifty (Trouli et al., 2008), with values 0-4 (0%8%) corresponding 
to no disability, 5-14 (10%-28%) to mild disability, 15-24 (30%48%) to moderate 
disability, 25-34 (50%-68%) to severe disability and 35-50 (70%-100%) to total 
disability (Magee, 2018).  
The scale was translated and validated in the Greek population by Trouli et 
al. (2008) and proved to be a reliable, valid, and useful tool for research and clinical 
environment of Greek primary health care. Very good test-retest reliability (ICC: 
0.93) and high internal consistency (Cronbach alpha=0.85) was indicated. Relation 
between the change score in the NDI and Global Rating of Change (GROC) was 
found (Spearman correlation coefficient = 0.3, P = 0.02). The Standard Error of 
Measurement (SEM) and the Minimal Detectable Change (MDC) were calculated 
as 0.64 and 1.78 respectively (Trouli et al., 2008).  
2.5.3.2.6. ANXIETY AND DEPRESSION (HOSPITAL ANXIETY AND 
DEPRESSION SCALE / HADS)  
Anxiety and depression will be recorded by the HADS scale. It is a selfreport 
scale of 14 items, which are classified on a four-point scale (Likert scale) numbered 

30  
  
0-3. It has two subscales; HADs_anxiety and HADs_depression, each of which 
contains seven items. The total score ranges from 0-21 for each subscale 
(Michopoulos et al., 2008), where values of 0-7 correspond to normal 
depression/anxiety, 8-10 to borderline abnormal, and 11-21 to abnormal (Hospital 
Anxiety and Depression Scale 2020).  
The Greek version of the HADS has been proven to has good test-retest 
reliability (ICC,HADS = 0.944, ICC,HADS_depression = 0.84 και ICC,HADS_anxiety = 0.90) and 
high concurrent validity between the HADS, the Beck Depression Inventory (BDI) 
and the State-Trait Anxiety Inventory (STAI) (BDI,HADS = 0.75, BDI,HADS_depression = 
0.72, STAI,HADS = 0.76, STAI,HADS_anxiety = 0.774) (Michopoulos et al., 2008).  
2.5.3.2.7. KINESIOPHOBIA (TAMPA SCALE KINESIOPHOBIA / TSK)  
Fear of movement will be captured with the TSK_GR which is a 17-item 
questionnaire with a score of 17-68. In 2005, it was validated by Georgoudis et al. 
(2005b) to the Greek population after examining 70 patients with chronic low back 
pain. Four values are assigned to each of the 17 questions; 1=Strongly disagree, 
2=Disagree to some extent, 3=Agree to some extent, 4=Strongly agree, and the total 
score is obtained after reversing questions 4, 8, 12 and 16. If the score is 37 or less 
then it is associated with a low fear of movement, while on the contrary, 37 or more 
with increased fear of movement. The Greek version was shown to have validity and 
reliability. The internal consistency attributed to Cronbach's coefficient was 0.74 
(a=0.74), a value considered satisfactory and even appeared increased (a=0.83) 
when questions 4, 8, 12 and 16 were not included (Georgoudis et al., 2005b).  
2.5.3.2.8. FEAR AND AVOIDANCE OF PAIN (FEAR- AVOIDANCE BELIEFS 
QUESTIONNAIRE / FABQ)  
To record the perception of fear and the effort to avoid pain in relation to 
physical and work activities, the Greek version of the FABQ questionnaire 
(FABQ_GR) will be chosen, which was validated by Georgoudis et al (2005a). The 
FABQ is a self-referential questionnaire consisting of 16 questions, each of which is 
scored from zero to six. Therefore, the total score is 96 points. Higher scores 
correspond to strong perceptions of fearing and avoiding pain. 
Consequently, it consists of two subscales; the FABQ_physical composed of 
four questions and assessing the aforementioned parameters in relation to physical 

31  
  
activities and the FABQ_work, of seven questions on the same perceptions at work, 
with scores ranging between 0-24 and 0-42 respectively. The remaining five 
questions aim to distract the patient. Both models, as demonstrated by a clinical 
study conducted in the Greek population -70 patients with chronic low back pain-, 
had satisfactory internal validity (FABQ_work Cronbach's a=0.86, FABQ_physical 
Cronbach's a=0.72) (Georgoudis et al., 2005a).  
2.5.3.2.9. PAIN CATASTOPHIZING (PAIN CATASTOPHIZING SCALE / PCS)  
Pain catastrophizing will be calculated with the Pain Catastrophizing Scale 
(PCS). It is a 13-item instrument derived from the definitions of catastrophizing 
analyzed in the literature and from items from the catastrophizing subscale of the 
Coping Strategies Questionnaire (CSQ). Participants will be asked to recall past 
painful experiences and rate each of 13 thoughts or feelings on a five-point scale, 
where zero (0) corresponds to not at all and four (4) to constantly/all the time. 
Furthermore, it has been shown to have adequate to excellent internal consistency 
and requires a reading level of about grade six, which corresponds to the level of a 
6-6.5-year-old child. It consists of three aspects of catastrophizing: Rumination (R) 
consisting of four questions, Magnification (M) consisting of three questions and 
Helplessness (H) consisting of six questions. The total score is calculated from the 
sum of the individual 13 question scores and ranges from zero to 52 (Sullivan 2009). 
The scale has been validated to the Greek population by Chatzidimitriou et al. 
(2006). The total form of Greek PCS has satisfactory internal consistency 
{(Cronbach’s alpha = 0.91) and its subscales (R: a = 0.79, M: a = 0.75, H: a = 0.88)}. 
Total PCS has also satisfactory test-retest reliability {(ICC = 0.82) and the subscales 
(ICC: R: 0.87, M: 0.73, H: 0.86)}. Its convergent and divergent validity have also 
been demonstrated as PCS has high correlation with the CSQ (r = 0.89) and 
moderate correlation with the affective subscale of the SFMPQ (r = 0.38, p < 0.01), 
the sensory subscale of the SFMPQ (r = 0.23, p < 0.01), the kinesiophobia (a = 0.51, 
p < 0.01), the anxiety subscale of the HADS (r = 0.49, p < 0.01) and the depression 
subscale of the HADS (r = 0.45, p < 0.01) (Chatzidimitriou et al., 2006).  
2.5.3.2.10. QUALITY OF LIFE (SF- 12 HEALTH SURVEY / SF-12)  
Quality of life will be assessed using the SF-12 questionnaire, which has been 
validated to the Greek population. The SF-12 is the short, alternative form of the SF-

32  
  
36 and assesses with the use of two items the parameters physical functioning (PF), 
physical and emotional role (role physical/RP, role emotional/RE) and mental health 
(MH) (Kontodimopoulos et al., 2007). The score is 56,577 and 60,757 for physical 
role and mental health respectively (OrthoToolKit 2020). The parameters bodily pain 
(BP), general health (GH), social functioning (SF) and vitality (VT) are controlled by 
one object each. It consists of two factors of conceptual structure; Physical 
Component Summary (PCS) -correlated with PF, RP, BP and GH- and Mental 
Component Summary (MCS) -correlated more with SF, RE and MH-. It is noted that 
the VT item has a slightly higher correlation with the PCS score. The SF-12 Health 
Survey has demonstrated its construct, convergent, divergent and concurrent 
validity in Greek general population (Kontodimopoulos et al., 2007).  
2.5.3.2.11. CHANGE OF HEALTH CONDITION (GLOBAL PERCEIVED EFFECT / 
GPE)  
The Global Perceived Effect (GPE) scale will rate the perceived change of 
the subject’s health condition. It asks the patient to rate how much their condition 
has worsened or improved relatively to another predetermined point in time (Evans 
et al., 2014). It is a numerical scale which consists of only one question with 5 
possible answers. This scale is often used in musculoskeletal conditions, especially 
when they are chronic, such as chronic neck pain (Meisingset et al., 2018). Despite 
the ease of application of the GPE, it is a challenge for patients to accurately 
remember the state in which they were recently and not to confuse the current state 
with the corresponding past state (Kamper et al., 2010).  
2.6. COMPLIANCE RATE  
In addition to the aforementioned, in the survey will also be recorded the 
compliance rate of the participants in the two interventions. This process will be 
carried out through a paper form that each participant will receive and complete at 
the end of the ten sessions. On this paper form the exercises to be performed at 
home will be written and next to them an Y (YES) or N (NO) will be marked 
depending on whether patients will have performed them or not.  
Participants' compliance with the exercise program at home will be assessed 
in two ways. The first way will include objective criteria such as whether they did the 

33  
  
exercises that they were given, the frequency with which they implemented them 
and the way in which they performed them (i.e. continuously or with breaks). The 
second way will involve the subjective view of each participant, who will self-assess 
the compliance that they will have demonstrated. The two assessing ways of 
compliance will be reduced to percentage scales (0%-100%), where higher scores 
will indicate higher compliance.  
2.7. COMPLAINT FORM  
Before the start of the interventions, each participant will be given a complaint 
form to submit their possible complaints and record the problems they may have 
encountered and/or their observations regarding the provided interventions, the 
overall design and organization of the research, the scientific group or anything else 
worth mentioning. 
2.8. PROCEDURE  
Initially, the prospective participants who will come from the structures mentioned 
in the section "Conducting research - Declaration of consent" will send through their 
electronic mail or by hand their medical diagnosis. The latter, combined with the 
exclusion criteria set, will be the way to sort the appropriate population. Participants 
will complete their consent form and demographic information. A full musculoskeletal 
assessment by an experienced physical therapist trained in the identification of 
myofascial pain trigger points (MTrPs) will be required at the start of the A-S group 
protocol. The determination of each MTrP will be achieved by palpation of the 
muscles under examination - upper trapezius and levator scapulae - based on the 
criteria of Travell and Simons (1992). The points will be marked with an indelible ink 
and recorded on a body chart. The skin will be cleaned with alcohol before the start 
of the intervention. The ATM technique requires no preparation.  
During the intervention period (five weeks) the exact protocol will be followed, as 
analyzed in the corresponding subsections "Group A-ATM (FM)" and "Group BA-S". 
Acupuncture sessions will take place in the Pain Clinic of the Aretaeio hospital and 
will be carried out at ambient temperature (25°C) as the reduced temperature 
causes vasoconstriction making it difficult to apply acupuncture. The treatment area 

34  
  
will be quiet, sunny and clean. The two interventions will take place in the morning 
and afternoon, from 8.30 am to 6.30 pm.   
Measurements will be carried out at the time points before the start of the 
intervention, after completion and at the follow-up at four months. In detail, PPT, 
ROM of flexion-extension, rotation and side flexion and neck position sense, 
respiratory function and flexor muscle strength will be recorded while patients will 
complete all seven questionnaires. From the total sample number, the patients 
participating in the follow-up will be calculated and therefore the cumulative dropout 
rate will be derived, which will be allocated to the two groups. Those who do not 
successfully complete treatment will be asked about the reasons that contributed to 
this. Finally, adverse effects from the application and/or ATM will be recorded.  
2.9. STATISTICAL ANALYSIS  
Quantitative variables will be expressed as mean and standard deviation 
(SD). Qualitative variables will be expressed as absolute (Ν) and relative (%) 
frequencies. Pearson’s χ2 test and Fisher's exact test (where it is necessary) will be 
used to compare proportions, as well as McNemar test will be used to compare the 
percentages of kinesiophobia between measurements. Student’s t-test or 
nonparametric criterion Mann-Whitney will be used for the comparison of the 
quantitative variables between the two groups. The change in the used scales and 
other indicators of the participants over time will be tested using linear mixed models 
from which dependence coefficients (β) and their Standard Errors (SE) will be 
obtained. The group, the measurement (endline vs baseline) and their interaction 
term (to be tested in which extent the change is different between measurements in 
the two groups), will be introduced as independent variables. In the cases, where 
the interaction term will be found significant, sex, age, BMI and the symptoms 
duration will be introduced in the model (the chosen confounding factors are the 
most significant), in order to be tested if the interaction remain significant. Moreover, 
in the case that measurements at some outcome measures will be found to differ 
significantly at the initial measurement between the two groups, a result not due to 
systematic error but found to be due to random sampling. In these cases, their initial 
values will be entered into the mixed linear models as an independent variable to 

35  
  
ensure that the findings from the models are not due to the initial differences 
between the groups. In cases that will be found significant differences between 
baseline measurements, between the two groups, the initial measurements will be 
introduced in linear mixed models as independent variable, in order to be ensured 
that the findings from these models are not due to initial differences between the 
groups. All reported p values will be two-tailed and statistical significance will be set 
at p < 0.05. Analyses will be conducted using the IBM SPSS Statistics 26.0.  
2.10. RESULTS  
Through the research, the effectiveness or the ineffectiveness of the FM will be 
highlighted and comparisons will be made between the effect of FM and A-S, 
regarding specific parameters (outcome measures), that will be evaluated at specific 
times (before and after the completion of the intervention - five weeks). Findings will 
be drawn for each hypothesis of both research questions with the aim of verifying or 
rejecting them. In detail, pain sensitivity, cervical ROM, endurance of the deep neck 
flexor muscles, respiratory function, intensity and quality of pain, functionality and 
psychological factors will be assessed and contrasted between the two 
interventions. After comparing the mean values of the groups in each assessment 
for each outcome measure, it will be established on the first level if the method under 
consideration has benefits in patients with chronic neck pain. On the second level, 
it will be established if it shows statistically significant results compared to the A-S 
intervention, if non-significant differences are detected between the two groups or if 
the active control group predominates. The findings will be presented for each 
outcome measure separately.  
2.11. DISCUSSION  
In the discussion the results will be recapitulated, analyzed and related to the 
existing literature. Each studied parameter of each research question will be 
assessed separately and the correlation based on the results obtained from the 
existing literature, which will be listed in the general part, will be highlighted. If the 
hypothesis is verified, then it will be compatible with the findings of the studies so 
far. Otherwise, it is against them. Finally, the above will be interpreted and the reason 
will be justified.  

36  
  
The aim of each study is to minimize the limitations, in order to draw safer 
conclusions and then to generalize the results.  
The sample will consist of a wide age and social spectrum, which provides 
more reliability to the study and increases the power of the FM, giving the possibility 
of its application without limitations. Furthermore, a wide variety of parameters will 
be evaluated in a large sample size, providing the possibility of deriving statistically 
significant results. The number of the participants is satisfactory and larger than that 
of the majority of studies analyzed in the literature review. Additionally, recording the 
compliance rate is an additional advantage and is not included in the most studies.  
In the limitations is included the design of the study, which is a 'single-blind' 
method, eliminating systematic error for the observer. Another limitation is 
represented by the heterogeneity in the severity of the patients' symptoms, which 
could be specified in the inclusion criteria. Also, the plethora of exclusion criteria, 
that were set due to the acupuncture may constitutes an obstacle to the promotion 
of the results in the general population. Last but not least, short-term or long-term 
follow-up will not be conducted.  
2.12. CONCLUSIONS-CLINICAL IMPLICATIONS  
The effect of ATM on a common clinical condition - chronic neck pain - will be 
established based on a standardized procedure with a single blind randomized 
controlled trial. The acupuncture-stretching combination is used by many 
researchers and the present study will contribute to the highlight of the effectiveness 
of this protocol in the examined clinical condition. Finally, a comparison of the two 
interventions will be carried out in terms of the evaluation parameters (pain 
sensitivity, cervical ROM, endurance of the deep neck flexor muscles, respiratory 
function, intensity and quality of pain, functionality and psychological factors).  
It should be taken into account that due to the lack of literature the investigation 
of the effects of FM is an unknown field, while the proper function of the cervical 
spine is of paramount importance. It attributed to the effects of the neck in spin’s 
function, as well as the function of the upper extremity. Consequently, the ATM 
technique is a valuable resource in prescribing exercises for patients. 

37  
  
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