Comparative Analysis of Different Physiotherapy Interventions on Craniovertebral Angle in Individuals With Myofascial Pain Syndrome and Radiculopathy: a Randomized Controlled Trial
Phase: NA
Conditions: Myofascial Pain Syndrome - Neck
Sponsor: National Orthopedic and General Hospital

15th Mar 2025 
Study Protocol 
Title: 
Comparative Analysis of Different Physiotherapy Interventions on 
Craniovertebral Angle in Individuals with Myofascial Pain Syndrome and 
Radiculopathy: A Randomized Controlled Trial 
 
 

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METHODOLOGY 
7.1 Study Design: This study will be a randomized controlled trial (RCT) with multiple 
treatment arms. 
7.2 Sampling Technique: Convenient Non-Probability Sampling technique will be used to 
select the sample. Selected participants will be randomly assigned to any of the intervention 
groups. 
7.3 Sample Size Calculation: Sample size of the study will be total 100 participants, divided 
into four groups. Each group will comprise of 25participants. It is calculated by G-Power 3.1 
software, based on a medium effect size (f) of 0.25, alpha level of 0.05, power (1-β) of 80%, 
correlation ® of 0.5, four groups and a non-sphericity correlation (€) of 1. 
7.4 Study Setting: Study will be conducted at Department of Rehabilitation at National Hospital, 
Bahawalpur, Punjab, Pakistan. 
7.5 Sample Selection Procedure: 
Sample will be selected according to following criteria: 
7.5.1 Inclusion Criteria: 
1. Age: Participants must be between 20 and 40 years old. 
2. Gender: Both genders, Male and Female have equal chance of selection as participant in 
the study. 
3. Diagnosis: Participants must have a confirmed diagnosis of myofascial pain syndrome 
(MPS), altered cervical posture, restricted range of motion of cervical spine due to 
muscular spasm etc, altered craniovertebral angle, pain in cervical region or upper 
extremity and/or radiculopathy by a qualified healthcare professional, based on 
standardized diagnostic criteria (e.g., clinical examination, imaging studies). 
4. Severity: Participants should have mild to moderate symptoms of MPS and/or 
radiculopathy, as determined by the assessing healthcare provider. 

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5. Willingness to Participate: Participants must be willing and able to comply physically and 
mentally with the study procedures, including attending scheduled physiotherapy sessions 
and completing outcome assessments. 
6. Informed Consent: Participants will have to provide written informed consent mendatorily 
to be selected as participant in the study after receiving detailed information about the study 
aims, procedures, potential risks, and benefits. 
7.5.2 Exclusion Criteria: 
1. Severe Comorbidities: Participants with severe comorbidities or medical conditions that 
may interfere with their ability to participate in the study or confound the interpretation of 
results will be excluded. C1, C2 compression… vertigo 
2. Surgeries: Participants who have undergone surgeries in the cervical or head region in past 
will be excluded due to potential confounding effects on outcomes. 
3. Pregnancy: Pregnant individuals will be excluded from the study due to the potential risks 
associated with certain physiotherapy modalities and the need for specialized 
considerations in this population. 
4. Contraindications: Participants with contraindications to specific physiotherapy modalities 
included in the study protocol (e.g., contraindications to dry needling, electrotherapy) will 
be excluded to ensure participant safety. 
5. Inability to Attend Sessions: Participants who are unable to attend scheduled physiotherapy 
sessions due to logistical constraints (e.g., transportation issues, scheduling conflicts) will 
be excluded. 
6. Cognitive Impairment: Participants with significant cognitive impairment or 
communication difficulties that may impede their ability to understand and follow study 
instructions will be excluded. 
7. Participation in Other Research: Participants who are currently participating in other 
research studies involving treatment interventions for MPS and/or radiculopathy will be 
excluded to avoid potential confounding effects on outcomes and treatment adherence. 

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8. Malignancies: participants suffering from any kind of malignancies will be excluded from 
the study. 
9. Trauma: Participants having a history of trauma and fractures in head and neck region will 
also be excluded from the study. 
These inclusion and exclusion criteria are designed to ensure the safety of participants, 
minimize confounding factors, and optimize the internal validity of the study results. 
7.5.3 Randomization and Group Allocation: 
• 
Participants meeting the inclusion criteria will be randomly assigned to one of the 
treatment groups using systematic allocation method (patients 1-4 will be allocated 
to each group with their respective numbers and the serial will be repeated 
accordingly). 
• 
Allocation concealment will be ensured to prevent selection bias, with treatment 
assignments concealed from both participants and investigators until after 
enrollment. 
7.6 Intervention and Group Allocation: 
7.6.1 Group Allocation: 
Participants will receive physiotherapy interventions based on their assigned treatment group. 
1. Group-A:  Dry Needling & Myofascial Release Group. 
2. Group-B: Trigger Point Therapy and Stretching Group. 
3. Group-C: Mobilization Grade-1 & Grade-2 And Cupping Therapy Group. 
4. Group-D: (Control group) Electrotherapy (TENS, Ultrasound) with stretching and Range of 
Motion Exercises. 
Intervention Duration: Interventions will be applied for four weeks. 
Intervention Frequency: Frequency of interventions will be twice a week. Total 08 
sessions will be applied to each participant at regular intervals as per standard clinical 
practice. 
7.6.2 Intervention Procedures: 

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Dry Needling:  
The patient will be lying prone; the sterile acupuncture needles of 0.25x25 mm (Hua Long) 
will be placed over the palpated trigger points at300 angle and pushed deeply into the taut 
bands/trigger points. We will make sure the trigger point is immobilised between the thumb 
and index finger. Considered suitable needle site is reproduction of pain or local twitch 
response. Left in situ for ten minutes, needles will be spun clockwise at the tenth minute and 
then left in situ for ten more minutes. The needles will be withdrawn after twenty minutes 
overall. We call this approach deep dry needling. (DDN) (Tasoglu O. et al, 2017) (Tekin L et 
al, 2013). 
Trigger Point Therapy:  
The subject will be in sitting position. Trigger points will be palpated by the expert physical 
therapist/healthcare provider in the upper trapezius region. The trigger point will be marked by 
marker. The trigger point will then be pressed with thumb by increasing pressure gradually 
until patient reports that pressure has been converted into pain. The subject will be instructed 
to indicate this by saying “Yes” when pressure sensation converts to pain. The examiner will 
then hold for 5seconds and will release the pressure. This procedure will be repeated 5-6times 
for each trigger point.  
Stretching:  
Passive static stretching of different neck muscle groups will be performed. The subject will 
be in supine lying position. Contralateral side flexion will be performed by the therapist to 
stretch upper trapezius on both sides, simultaneous ipsilateral flexion and rotation will be 
performed to stretch scalenes on both sides, flexion will be performed to stretch extensor 
muscles of neck. Similarly, extension will be performed to stretch flexors of neck. All above 
stretches will be held for 30 seconds and will be repeated for 4-5times with a gap of 10-
15seconds between each stretch. Lastly, neck straightening exercises will be performed by 
retruding the head (chin tucks) to stretch suboccipital muscles, held for 3-5seconds and 
repeated for 4-5times with a gap of 10-15sconds (Hakkinen A et al, 2007).  
Mobilization:  
Maitland mobilization techniques will be used for this purpose. Patient will be in sitting 
position. Grade-I and Grade-II Maitland mobilizations will be applied at all the cervical joints 

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as well cervicothoracic junction. Frequency of mobilizations shall be 2-3 oscillations per 
minute for 3-4minutes (Shabbir M et al, 2021).  
Cupping therapy:  
On each day of the trial, the participants will experience dry cupping intervention with a 
negative pressure of 400 mmHg following their regular training. This intervention will last for 
up to 15 minutes each time, twice a week, with a minimum of two days between each session. 
When performing cupping therapy, there will be a total of six cups utilised, and each cup will 
be positioned at the upper, middle, and lower fibres of the trapezius muscles simultaneously 
on both sides. On the basis of the distribution map of common myofascial sites in the upper 
back, the position of the cups will be determined. (YC Cheu et al, 2020).  
7.6.3 Variables: 
• Craniovertebral Angle (CV Angle) 
• Pain 
• Range of motion 
• Balance 
• Quality of life 
7.7 Outcome Measures: 
Following outcome measures will be used to assess the effects of applied interventions: 
Primary Outcome Measures: 
1. Craniovertebral (CV) Angle: CV angle will be measured with digital photography and 
MicroDicom software. 
2. Pain: Numeric Pain Rating Scale (NPRS) will be used for pain severity measurement. 
Secondary Outcome Measures: 
1. Range of motion: Range of motion of different joints will be measured by Goniometer. 
2. Balance: Balance of participants will be measured by Y balance test. 
3. Quality of life: Quality of life will be measured by SF-36 Questionnaire. 
7.8 Data Collection Procedures: 

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Data will be collected at three levels during application of interventions as follows. 
• 
Pre-Intervention (Baseline): Baseline assessments of all participants will be conducted before 
the interventions to establish initial measurements. 
• 
Interventions will be implemented as per the assigned groups, ensuring consistency in treatment 
delivery and adherence to the defined protocols. 
• 
Mid-Intervention: Assessment of all participants will be conducted at the end of 2nd week. 
• 
Post-Intervention: Outcome data will be collected at the end of defined intervention duration i.e 
four weeks to assess the effects of implemented interventions.  
7.8.1 Data Collection Tools and procedures: 
• 
Digital camera 
• 
MicroDicom Software 
• 
Tripod stand 
• 
Numerical Pain Rating Scale (NPRS) 
• 
CROM Deluxe 
• 
Y Balance kit (safety belt use) 
Craniovertebral Angle (CVA) Measurement: 
CVA is defined as the angle formed between two reference lines: one passing via the centre of the 
tragus of ear to the tip of spinous process of seventh cervical vertebra (C7); other is the horizontal 
line passing from same point of spinous process of seventh cervical vertebra (C7). There are 
several tools and techniques at hand for CV angle measurement. Using Digital Photography and 
MicroDicom Software is one of the less expensive approaches of gauging this angle. 
According to this method, measurements will be carried out in room with non-reflective 
background. The subject will be standing relaxed in a neutral posture in front of this non-reflecting 
background. Tip of C7 and tragus of ear will be marked by a reflective material to highlight the 
points for better clarity. External body landmarks will be palpated by atleast two experts before 
plotting the markers. 20MP Photography camera will be positioned on tripod stand such that upper 
level of tripod stand is at the level of shoulder point of subject and camera fixed on it. Distance of 
camera from the subject shall be 2.90meters. For assuring accuracy, points for feet of tripod as 
well as for the subjects will be marked from start of study till completion of data collection. Subject 
will stand relaxed at the marked area (with feet six inches apart) with arms on sides and relaxed. 

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Photograph(s) then will be taken with camera at zero zoom. The subject will be asked then to move 
around few steps, come back to the marked point again, attain the same posture and photograph(s) 
will be taken again. Procedure will be repeated three times for each subject. After that, photographs 
will be imported to computer and analyzed in MicroDicom Software. Average of three 
photographs will be taken as final value of CV angle. Normal value of CV angle is 48-50degrees. 
(Mazhar et al. 2021; Shinde et al. 2022) 
 
 
Pain Measurement: 
An outcome assessment with a uni-dimensional scale, the Numeric Pain Rating Scale (NPRS) 
gauges personal pain intensity. With "0" being the least degree of pain possible, the eleven-
point numerical scale runs from "0" indicating one pain extreme—for example, "no pain"—to 
"10" representing the opposite pain extreme—for example, "pain as bad as you can imagine" 
or "worst pain imaginable". (Jensen MP, 1993, Rodriguez CS , 2001). 
 

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Range of Motion Measurement:  
Range of motion of following neck movements will be measured: 
• Cervical flexion (Normal range) 
• Cervical extension 
• Cervical rotation 
• Cervical lateral flexion (left) 
• Cervical lateral flexion (right) 
For collection of range of all these movements, a standard instrument, CRom Deluxe, 
manufactured by Baseline, is a specially designed and standardized instrument for measuring 
cervical ranges of motion. Instrument will be worn by the subject, sitting comfortably in a chair. 
Ranges of all movements will be then be checked by asking the subject to perform each movement 
while therapist will be checking and recording values. Procedure will be repeated three times to 
have better accuracy. (Audette et al. 2010) 
 
 
 
 
 
 
 
 
 
 
 
CROM 
 
 

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Balance Assessment: 
Y balance test is a reliable and valid instrument for balance measurement. It is a very useful tool 
to assess dynamic balance in different subjects.  
The Y Balance Test (YBT) is a dynamic balance assessment tool that evaluates an individual's 
balance and functional symmetry through reaching tasks. The participant stands on one leg (the 
stance leg) with the opposite leg positioned behind them, maintaining a slight bend in the knee and 
keeping their hands on their hips for balance. The test consists of three reach directions: anterior 
(forward), posteromedial (diagonal backward toward the stance leg), and posterolateral (diagonal 
backward away from the stance leg). For each direction, the participant leans while keeping the 
stance leg straight and touches the reach indicator with the toes of the opposite leg, performing 
three attempts per direction and recording the best distance reached. After completing the reaches 
on one leg, the participant switches to the opposite leg and repeats the procedure. The distances 
reached are measured and recorded, allowing for a composite score to be calculated by summing 
the best reach distances from each direction. This test helps identify balance capabilities and 
potential risks for injury by comparing scores between the two legs. 
 
 
 
 
 
 
 
 
Quality of life assessment:  
The status of one's general health can be determined by using the SF-36. Eight scaled scores are included; 
these scores are weighted sums of the questions that are included in each section. Scores range from 0 - 100 
(McHorney CA,1994, Ware JE, 1993, Ware JE, 1992) 
   Sections:  
1. Vitality  
2. Physical functioning  

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3. Bodily pain  
4. General health perceptions  
5. Physical role functioning  
6. Emotional role functioning  
7. Social role functioning  
8. Mental health 
Lower scores = more disability, higher scores = less disability  
 
7.10 Ethical Considerations: 
• 
Intervention environment (lighting, cleanliness, comfortability, temperature 
control, waiting area) will be managed to be satisfactory, minimizing any distress 
to the participants during study. 
• 
Any research study must justify the potential benefits of the study against the any 
possible harm/distress caused to the participant(s). This involves considering the 
scientific significance of the research, its potential impact on human health, and 
whether the benefits outweigh the ethical concerns raised. 
• 
Prior to enrolment, an informed consent form that was self-designed will be utilised 
for all participants, and the protocol for the study will be evaluated and approved 
by the ethical committee of the institution. 
• 
It is guaranteed that participants will be kept anonymous, and they will have the 
choice to withdraw from the study at any moment without incurring any penalty. 
• 
Helsinki guidelines will be duly followed during conduction of study.  
• 
Safety and well-being of participants will be given a top priority.  
• 
Research study will adhere to obligation of accurately reporting findings of study, 
whether positive or negative, without manipulation or selective reporting. 
• 
Study will adhere to principle of beneficence as well by ensuring that intervention 
programs and protocols are designed to provide potential health benefits to 

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participants. Participants should not be exposed to unnecessary risks. Protocols 
should be in accordance with the proper guidelines which must be followed during 
the conduction of study. 
• 
Participants autonomy about taking his/her decisions about his/her health must be 
respected at all times.  
7.11 Limitations:  
1. Finding Target Population with Proper Diagnosis and Referral: Identifying a target 
population that meets specific diagnostic criteria can be challenging. This limitation arises from 
the need for accurate and consistent referrals from healthcare professionals. If the referral process 
is not standardized, it may lead to a sample that is not representative of the broader population. 
Additionally, variations in diagnostic practices among different healthcare providers can result in 
discrepancies in the population selected for the study. This inconsistency can affect the 
generalizability of your findings, as the sample may not accurately reflect the characteristics of the 
larger population you aim to study. 
2. Finding Equal Samples from Both Genders: Achieving gender balance in your sample is 
crucial for ensuring that your findings are applicable to both males and females. However, this can 
be difficult due to inherent biases in the population or the nature of the condition being studied. 
For instance, if the condition is more prevalent in one gender, it may be challenging to recruit an 
equal number of participants. This limitation can lead to skewed results and may affect the 
interpretation of how the condition impacts different genders. Furthermore, if the sample is not 
balanced, it could limit the ability to draw meaningful comparisons between genders, thereby 
affecting the overall conclusions of your research. 
3. Getting Permission to Take Body Images for Calculating the Required Angle: Obtaining 
consent for taking body images can pose ethical and logistical challenges. Participants may have 
concerns about privacy, body image, and the potential misuse of their images, which can lead to 
reluctance in providing consent. This limitation can result in a smaller sample size or a biased 
sample if only those who are comfortable with body imaging agree to participate. Additionally, 
the process of obtaining permission can be time-consuming, potentially delaying the research 

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timeline. If the sample is limited to those who consent, it may not adequately represent the broader 
population, thus affecting the validity of the results. 
4. Resource limitations: Resource limitations, such as funding and proper staffing, may 
undermine the ability to follow guidelines fully and provide a comprehensive medical supervisory 
approach and support. 
5. Generalizability: Study findings can be confidently applied to limited geographic area where 
study is being performed, sample not being homogenized for a bigger geographic territory which 
may affect the generalizability of the study. 
 
 
 
 
 
 
 
 

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8. GANTT CHA

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