| CTRI Number |
CTRI/2025/07/091045 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on Stretching and Release Techniques for People with Long Term Neck Pain and Pain Spreading to Arms |
|
Scientific Title of Study
|
Effectiveness of Neural Stretching and Distalo-proximal Release Technique for the Management of Chronic Neck Pain with Referred symptoms.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha Kumari Ray |
| Designation |
Undergraduate Student |
| Affiliation |
Jashore University of science and Technology |
| Address |
Room 304 Department of Physiotherapy and Rehabilitation
Jashore University of Science and Technology
Room 304 Department of Physiotherapy and Rehabilitation
Jashore University of Science and Technology
7408
Other |
| Phone |
8801732949609 |
| Fax |
|
| Email |
manisharay142@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant professor |
| Affiliation |
Jashore University of science and Technology |
| Address |
Room 307 Department of Physiotherapy and Rehabilitation
Jashore University of Science and Technology
Room 307 Department of Physiotherapy and Rehabilitation
Jashore University of Science and Technology
7408
Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
sh.jahan@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant professor |
| Affiliation |
Jashore University of science and Technology |
| Address |
Room 307 Department of Physiotherapy and Rehabilitation
Jashore University of Science and Technology
Room 307 Department of Physiotherapy and Rehabilitation
Jashore University of Science and Technology
7408
Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
Sh.jahan@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy and Rehabilitation Level 2 and 3, Dr MR khan Medical center, Jashore University of Science and Technology,Jashore 7408
|
|
|
Primary Sponsor
|
| Name |
Dr Ehsanu Rahman |
| Address |
Room 401 Department of Physiotherapy and Rehabilitation Jashore University of Science and Technology, Jashore -7408 Bangladesh |
| Type of Sponsor |
Other [University] |
|
|
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 Kabir Hossain |
Dr MR khan Medical center |
Level 3,Room 301,
Musculoskeletal Lab Department of Physiotherapy and Rehabilitation ,Jashore University of Science and Technology,Jashore -7408
|
8801778315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of physiotherapy and Rehabilitation JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M434||Other recurrent atlantoaxial dislocation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
The total intervention period will be 8 weeks comprising 16 sessions in total Participants will attend 2 sessions per week with each session lasting approximately 30 to 35 minutes
Each session will include
Warm-up phase 3to5 minute Gentle range of ROM exercises.
Main therapeutic intervention.
Cool-down phase 2–3 minutes Breathing exercises or relaxation techniques
|
| Intervention |
Neural Stretching and Distalo-Proximal Release Technique |
Neural stretching and distalo proximal release technique gives to the associated structure the radial ulnar and medial nerve distalo release to the palmar fascia to the forarm muscle shoulder and neck muscles Total duration 8 weeks
Session 16
Session frequency 2 session
Session duration 30 to 35 minutes including warm up 3to5minutes(ROMexercises) and cooldown 2to3 minutes (breathing or relaxation) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Men and women aged between 18 to 50 years with complaints of neck pain radiating into the arm, hand, or fingers, accompanied by numbness, weakness, and headache. |
|
| ExclusionCriteria |
| Details |
History of cervical spine surgery
Diagnosis of rheumatoid arthritis (RA)
Currently pregnant or planning pregnancy during the study period
Recent history of fracture (within the past 6 months)
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain by Visual Analog Scale (VAS) |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ROM by using a digital goniometer
Quality of life
Functional mobility improvement measure by NDI neck disability
index
Patient’s specific functional scale PSFS |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="0"
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
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Sh.jahan@just.edu.bd].
- For how long will this data be available start date provided 07-07-2025 and end date provided 10-07-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effectiveness of Neural Stretching and Distalo-Proximal Release Technique in the management of chronic neck pain with referred symptoms. Participants aged 18–50 years experiencing neck pain radiating to the upper limbs, along with symptoms such as numbness, weakness, and headache, will be included. The study will be conducted at multiple centers where eligible participants will be randomly allocated into two groups. The experimental group will receive neural stretching and distalo-proximal release techniques, while the control group will undergo conventional physiotherapy. Outcomes will be assessed using the Visual Analog Scale (VAS) Neck Disability Index (NDI), Patient-Specific Functional Scale (PSFS) and a digital goniometer. The study will follow CONSORT guidelines, and the intervention will be provided by qualified physiotherapists. The primary outcome is pain measured by VAS, and the secondary outcomes are ROM using a digital goniometer and functional mobility improvement measure by NDI neck disability index and patients specific functional scale.
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