| CTRI Number |
CTRI/2025/08/093602 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| 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
|
Comparison of Active Release Technique and Maitland Mobilization in non-specific neck pain |
|
Scientific Title of Study
|
Comparison of the Effectiveness of Active Release Technique with Maitland Mobilization in Patients with Non-Specific Neck Pain. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dakshinayan Maruti Wadhawe |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Department of musculoskeletal physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongari Hinga Road Nagpur MAHARASHTRA 441110 India
Department of musculoskeletal physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongari Hinga Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9767234562 |
| Fax |
|
| Email |
dakshinayanwadhawe226@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Deshmukh |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Department of musculoskeletal physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongari Hinga Road Nagpur MAHARASHTRA 441110 India
Department of musculoskeletal physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongari Hinga Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8888826093 |
| Fax |
|
| Email |
nehadeshmukh57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dakshinayan Maruti Wadhawe |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Department of musculoskeletal physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongari Hinga Road Nagpur MAHARASHTRA 441110 India
Department of musculoskeletal physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongari Hinga Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09767234562 |
| Fax |
|
| Email |
dakshinayanwadhawe226@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College of Physiotherapy, Wanadongri Hingna Road Nagpur-441110, Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy |
| Address |
Shri Datta Meghe Polytechnic Campus, Wanadongari Hingna Road Nagpur MAHARASHTRA 441110 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dakshinayan Maruti Wadhawe |
Datta Meghe College of Physiotherapy, Wanadongari Hingna Road Nagpur |
Department of musculoskeletal physiotherapy OPD, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongari Hinga Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA |
09767234562
dakshinayanwadhawe226@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved, Physiotherapy, Nursing (APN) Colleges Institutional Ethical Commettee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active Release Technique |
In the ART group, ART will used to treat the muscles demonstrating scar tissue particularly targeted trapezius muscles such as upper, middle and lower fiber of trapezius muscle. After shortening based on fiber texture in the longitudinal direction apply firm pressure over the muscle, do the active movement of that particular muscles and active stretching to lengthen the tissue that had been shortened. with traditional physiotherapy |
| Comparator Agent |
Maitland Mobilisation |
The second study group will receive Maitland mobilization with including postero-anterior Maitland mobilization Grade II at the level of C5-C6. Frequency of mobilization was two days a week for three weeks. While intensity of mobilization was based on the Maitland concept. Time of oscillations was two or three oscillations in a second for one to two minutes. with traditional physiotherapy |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1 Having non-specific neck pain
2 Patients with negative special test for cervical region
3 Neck disability index score more than or equal to 15
|
|
| ExclusionCriteria |
| Details |
1 Traumatic injuries
2 Previous neck or shoulder surgery
3 Previous steroid injection or acupuncture
4 On x-ray MRI diagnosed case of cervical spine spondylolisthesis spondylosis spondylitis disc protrusion extrusion or sequestration
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Cervical ROM for flexion/ extension/ lateral flexion/ lateral rotation using full circle universal Goniometer
2.Numerical pain rating scale (NPRS)
3.Neck disability index (NDI)
|
before beginning of treatment and after end of treatment (before day 1 of treatment and after 3rd week of treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Neck disability index (NDI)
|
before beginning of treatment and after end of treatment (before day 1 of treatment and after 3rd week of treatment) |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
02/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Non-specific neck pain
(NP) is characterized by pain in the posterior and lateral aspect of the neck
between the superior nuchal line and the spinous process of the first thoracic
vertebra without any indications or symptoms of a major structural pathology,
without causing minor to major interference with day-to-day activities, and
without any neurological signs or specific pathologies, such as tumors,
infectious or inflammatory cervical spondylolysis, traumatic sprains and
fractures, etc. The
patients will be selected according to inclusion and exclusion criteria. Once
consent is obtained Cervical range of motion would be assessed with the help of
goniometer, and pain will be assessed with Numerical Pain Rating Scale (NPRS)
and Neck Disability Index scale (NDI) before starting treatment. The subjects with Non-specific neck pain included in the study were randomly assigned to one of two groups
pre-test/post-test design. For 3 weeks, the ART and Maitland mobilization
groups received treatment twice per week for 20 minutes. After all the
interventions were completed, the NPRS score, NDI score, and ROM were measured
again. |