Clinical trial NCT05870371: The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain
Official title: The Effectiveness of the Feldenkrais Method in Reducing Pain and Improving Functionality in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Feldenkrais
Awareness Through Movement
Functionality
Non specific
Chronic Neck Pain
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This doctoral thesis is a single blind randomized controlled clinical trial with an active control element. The intervention examined in this trial is the Awareness Through Movement (ATM) technique of the Feldenkrais Method (FM), while the standard treatment given to the control group is the combination of acupuncture and stretching.

The study was designed to examine the extend of the effect of ATM, as a means of reduction of pain, improvement of functionality and psychosomatic parameters of patients with chronic neck pain, in comparison to biomedical acupuncture protocol in combination with stretching.

The effectiveness of the intervention will be compared to the effect of the standard treatment, a combination of acupuncture and stretching, in relation to parameters of pain, range of motion of rotation, flexion-extension and lateral flexion of the cervical spine and the sense of position (kinesthesia), the endurance of the cervical deep flexor muscles, respiratory function and psychometric characteristics, which are evaluated at specific times (before and after the intervention-five weeks).

During the discussion, the results of this study, in combination with the degree of validity of the observation, will be compared to those of the literature review. This comparison could contribute to the more effective clinical application of ATM in the treatment of chronic neck pain, either as part of physiotherapeutic rehabilitation, or as a unique approach.

Detailed description: Chronic neck pain is a common phenomenon in the adult population with a prevalence of about 15%, while it is indicative that 2/3 of the population will develop neck pain during their lifetime with slight predominance in women. In physiotherapy, a number of therapeutic techniques are available to treat chronic neck pain. Although no obvious, single treatment option has been shown to be the most effective, systematic reviews show that rehabilitation in a variety of forms has the strongest evidence for the effectiveness of relieving chronic neck pain. In these forms, complementary therapies such as acupuncture, chiropractic, yoga, Tai Chi as well as sensory-motor approaches such as the Feldenkrais method are incorporated.

Contemporary articles, found in 6 studies, investigate the effect of the Feldenkrais method (Feldenkrais Method/FM) in chronic neck pain and date between the years 1999-2014. Primary outcome measure was pain, while secondary assessed disability, functional status and quality of life. The findings in the majority showed initial positive indications for the application of FM in the management of chronic neck pain. However, further high-quality methodological studies are required in order to draw reliable conclusions.

This doctoral thesis is a single blind randomized controlled clinical trial with an active control element, where the intervention is the Feldenkrais Awareness Through Movement (ATM) technique and the standard treatment given to the control group is the combination of acupuncture and stretching, due to its scientifically proven efficacy and widespread use as the treatment of choice in this pathology.

The study was designed to examine whether and to what extent ATM application will reduce pain, improve functionality in patients with chronic neck pain and have a positive effect on the psychosomatic parameters of pain, firstly as an individual intervention and in comparison with biomedical acupuncture protocol in combination with stretching secondly.

The purpose of the study is twofold:

i. The highlight of indications for statistically significant differences in the mean values of the variables, which investigate the pain pressure threshold and objective evaluation of pain (Short Form of McGill Pain Questionnaire/SFMPQ), functionality (Neck Disability Index/NDI), range of motion of rotation, flexion-extension and lateral flexion of the cervical spine and the sense of position (kinesthesia) (3D sensor inertial motion MOOVER), the endurance of the cervical deep flexor muscles (biofeedback stabilizer pressure / Chattanooga Stabilizer Biofeedback), assessment of respiratory function (portable spirometer by MIR / MIR Spirodoc), and psychometric characteristics (Hospital Anxiety and Depression Scale/HADs, Tampa Kinesiophobia Scale/TSK_GR, SF-12 Health Survey/SF-12, Fear-Avoidance Beliefs Questionnaire/FABQ_GR, Pain Catastrophizing Scale/PCS) for group A-FM (Intervention Group-IG) and group B-acupuncture with stretching (Control Group-CG).The measurements will be performed before (pre) and after (post) of the application of the ATM technique in order to evaluate the effectiveness of each intervention separately.

ii. The comparison between the two groups, the determination of the values of the above variables before and after, during the time period of five weeks in which the two programs will be implemented in parallel.

The sample will consist of 160 patients of both sexes, aged 19-70 years, with diagnosed chronic non-specific neck pain, with a duration of pain at least three months before the initial assessment and participation in the study. The selection will be made by the method of random sampling within a period of time and the participants will be distributed by simple randomization (equal allocation) in two equal groups of 80 people each. To achieve the objectives of the study, 10 sessions will be conducted over a period of five weeks, either of the ATM technique (intervention group), lasting 50 minutes, or of biomedical acupuncture in combination with stretching (control group), 40 minutes (25 minutes acupuncture plus 15 minutes stretching). The intensity of the pain will be assessed with an algometer, the range of motion of the flexion-extension, rotation and lateral flexion and the sense of the position of the neck with 3D sensor inertial motion MOOVER, the endurance of the deep neck flexor muscles with a biofeedback stabilizer and the respiratory function with a spirometer. In addition, the sample will complete a series of questionnaires that elicit information about chronic neck pain and the dysfunction caused by chronic neck pain.

The statistical analysis will be performed with the International Business Machines (IBM) Corporation software.

The effectiveness or not of the FM will be highlighted and comparisons will be made between its effect and acupuncture plus stretching in relation to specific parameters that are evaluated at specific times (before and after the intervention-five weeks).

During the discussion, the results of this study will be compared with those of the literature review. In combination with the degree of validity of the observation (power analysis) of this study, the literature data will be taken into account and those results will be extracted, which could contribute to the more effective clinical application of FM in the treatment of chronic neck pain either as part of physiotherapeutic rehabilitation or as a unique approach.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic non-specific neck pain
* The duration of the symptoms should be at least three months before the initial evaluation and their participation in the study.
* Existence of reported symptoms of non-rheumatic etiology on the shoulder or upper extremity.
* Age range 19-70 years.

Exclusion Criteria:

* History of surgery in Cervical Spine (Dibai-Fihlo et al. 2017)
* Patients with a history of neck fracture or injury (Campa-Moran et al. 2015, Dibai-Fihlo et al. 2017) in the last year
* Surgery on the head, face or neck (Dibai-Fihlo et al. 2017)
* Active cervical hernia with radical symptoms or severe degenerative diseases in Cervical Spine (Dibai-Fihlo et al. 2017)
* Systemic diseases (diagnosed rheumatic, metabolic and immune diseases), (Edward \& Knowles 2003, Wilke et al. 2014, Campa-Moran et al. 2015, Cerezo-Téllez et al. 2016 Dibai-Fihlo et al. 2017, Cerezo -Téllez et al. 2018)
* Myelopathy with severe disc or bone damage (Ma et al., 2010, Campa-Moran et al. 2015)
* Cervical rhizitis / rhizopathy (Ma et al. 2010, Wilke et al. 2014, Campa-Moran et al. 2015)
* Arterial dysfunction (Kerry et al. 2008)
* Tumors active during the last five years
* Lymphadenopathy (Tsakitzidis et al. 2013)
* History of inflammatory arthritis (Tsakitzidis et al. 2013)
* Diagnosed psychiatric illness (Wilke et al. 2014, Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
* Severe neurological disorder (Edward \& Knowles 2003, Wilke et al. 2014) or mental retardation (Ma et al. 2010)
* Signs, Symptoms or History of Mouth Pain and Temporomandibular Disorders Based on the Research Diagnostic Criteria of Temporomandibular Disorders (RDC / TMD) (Campa-Moran et al. 2015)
* Fibromyalgia syndrome diagnosed (Ma et al. 2010, Wilke et al. 2014, Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018) Infection or inflammatory swelling in the treated area
* Skin damage (Edwards \& Knowles 2003) or wounds in the area of the piercing (Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
* Systematic intake of medications that may affect the patient's judgment (eg neuromodulators, antidepressants)
* Taking systemic treatment for the same problem (Wilke et al. 2014) up to three months before the study
* Pregnancy (Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
* Previous Adverse Acupuncture Reaction (Edwards \& Knowles 2003)
* Allergy to metal (Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
* Fear of the needle (Edwards \& Knowles 2003, Campa-Moran et al. 2015, Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
* Inability to express speech and writing in the Greek language

Primary outcomes:
measure: Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Secondary outcomes:
measure: Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Endurance of Deep Cervical Flexor Muscles of the Spine Measured by Chattanooga Stabilizer Pressure Biofeedback (PRESSURE BIOREACTION STABILIZER )
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Forced Vital Capacity (FVC) Measured by the Spirometer MIR Spirodoc
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Vital Capacity (VC) Measured by the Spirometer MIR Spirodoc
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Maximum Voluntary Ventilation (MVV) Measured by the Spirometer MIR Spirodoc
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Pain Intensity Measured by the Visual Analogue Scale
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Present Pain Intesity Measured by the Present Pain Intensity Index.
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Neck Disability Measured by the Neck Disability Index
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Anxiety and Depression Measured by the Hospital Anxiety and Depression Scale
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Kinesiophobia Measured by the Tampa Scale Kinesiophobia
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Perception of Fear and Trying to Avoid Pain in Relation to Physical and Work Activities Measured by the Fear Avoidance Beliefs Questionnaire.
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Quality of Life Measured by the Short Form 12 Health Survey.
timeFrame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
measure: Global Perceived Effect Measured by the Global Perceived Effect Scale
timeFrame: Participants were assessed after the completion of the interventions (five weeks).
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaio Hospital
state: Attica
city: Athens
country: Greece
facility: Laboratory of Musculoskeletal Physiotherapy, University of West Attica
state: Attica
Study officials:
affiliation: University of West Attica
name: CHARALAMPOS SKORDIS
role: PRINCIPAL_INVESTIGATOR
References: