| CTRI Number |
CTRI/2025/02/081460 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of SCM & Scalene muscle release for Chronic Neck pain |
|
Scientific Title of Study
|
Effectiveness of Active release Techniques on Sternocleidomastoid & Scalene muscle for Chronic Neck pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Ashfaquzzaman |
| Designation |
Clinical Physiotherapist |
| Affiliation |
Centre for the rehabilitation of the Paralysed |
| Address |
Savar
CRP
Uttar Dinajpur
WEST BENGAL
2340
Other |
| Phone |
01992008888 |
| Fax |
|
| Email |
ashfaquzzaman02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Mohammad Anwar Hossain |
| Designation |
Senior Consultant and Head of Department of Physiotherapy |
| Affiliation |
Centre for the Rehabilitation of the Paralysed |
| Address |
Savar
CRP
Uttar Dinajpur
WEST BENGAL
2340
Other |
| Phone |
01730059633 |
| Fax |
|
| Email |
anwar_physiobd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Ashfaquzzaman |
| Designation |
Clinical physiotherapist |
| Affiliation |
Centre for the rehabilitation of the Paralysed |
| Address |
Savar
CRP
Uttar Dinajpur
WEST BENGAL
2340
Other |
| Phone |
01911008052 |
| Fax |
|
| Email |
ashfaquzzaman02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy.
Centre for the Rehabilitation of the Paralysed, Savar- 1340.
BANGLADESH. |
|
|
Primary Sponsor
|
| Name |
Md Ashfaquzzaman |
| Address |
Savar |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Ashfaquzzaman |
Centre for the rehabilitation of the Paralysed |
Savar
|
01992008888
ashfaquzzaman02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active release technique on Sternocleidomastoid and Scalene muscle of the neck |
Active release technique on Sternocleidomastoid and Scalene muscle for chronic neck pain |
| Comparator Agent |
conventional physiotherapy for neck pain |
conventional physiotherapy except ART on SCM and scalene muscles like mobilization, stretching, range of motion exervise, IRR, Ice,deep friction, soft tissue release etc. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Both |
| Details |
Adults aged 18-50 years old, both male and female will be included.
Chronic neck pain for at least 3 months.
Average neck pain intensity of at least 3 on a 0-10 Numerical Rating Scale.
No history of cervical spine surgery.
No significant neurological deficits.
No evidence of cervical spine fracture or instability.
No recent trauma to the cervical spine.
No inflammatory or infectious conditions of the cervical spine.
No radicular pain (pain radiating down the arm).
No contraindications to exercise (e.g., severe. cardiovascular disease, uncontrolled hypertension).
Ability to understand and follow instructions.
|
|
| ExclusionCriteria |
| Details |
Current participation in any other neck pain treatment program.
Pregnant or breastfeeding women.
Participation in contact sports or high-risk activities.
Severe psychiatric conditions.
Cognitive or intellectual impairments.
Difficulty communicating or cooperating with researchers.
Unwillingness or inability to comply with the study protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the effectiveness of sternocleidomastoid and scalene muscle active release techniques for chronic neck pain and improving associated function in individuals with chronic non-specific neck pain. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain reduction, increase ROM of neck, to check neck disability |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim To investigate the effectiveness of sternocleidomastoid and scalene muscle active release techniques for chronic neck pain and improving associated function in individuals with chronic non-specific neck pain. Objective · To assess the involvement of the sternocleidomastoid and scalene muscles on chronic neck pain, measured by the Brief pain Inventory questionnaire. · To evaluate the effect of the treatment on cervical ROM. · To explore the influence of treatment on disability and quality of life, assessed by the NDI. ·TTo compare the effectiveness of the sternocleidomastoid and scalene muscles release to the control group receiving conventional physiotherapy treatment. Alternative Hypothesis (Ha) There is a significant difference between the sternocleidomastoid and scalene muscles active release technique group and control group for chronic neck pain. Null Hypothesis (Ho) There is no significant difference between the sternocleidomastoid and scalene muscles active release technique group and control group for chronic neck pain. |