| CTRI Number |
CTRI/2023/09/057597 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| 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
|
A comparison of the effects of muscle energy techniques and upper neck release on pain and mobility in individuals with mechanical neck pain |
|
Scientific Title of Study
|
Immediate Effects of Muscle Energy Technique versus Suboccipital Release Technique on pain and Range of motion in individuals with mechanical neck pain : A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rasika Kate |
| Designation |
Post Graduate Student |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti institute for Orthopaedics and Rehabilitation College of physiotherapy, 11/12 Thube Park,shivajinagar,
Pune
MAHARASHTRA
411005
India
Pune
MAHARASHTRA
411005
India |
| Phone |
8600523916 |
| Fax |
|
| Email |
rasikakate27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilima Bedekar |
| Designation |
HOD musculoskeletal physiotherapy |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti institute for Orthopaedics and Rehabilitation College of physiotherapy, 11/12 Thube Park,shivajinagar,
Pune
MAHARASHTRA
411005
India
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nilimabedekar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilima Bedekar |
| Designation |
HOD musculoskeletal physiotherapy |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti institute for Orthopaedics and Rehabilitation College of physiotherapy, 11/12 Thube Park,shivajinagar,
Pune
MAHARASHTRA
411005
India
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nilimabedekar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Pune |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy
11/12, Thube Park, Shivajinagar, Pune - 411005 |
| Type of Sponsor |
Private medical college |
|
|
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 Rasika Kate |
Sancheti Institute for Orthopaedics and Rehabilitation |
Department of Musculoskeletal Physiotherapy Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy
11/12, Thube Park, Shivajinagar, Pune - 411005
Pune
MAHARASHTRA |
8600523916
rasikakate27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Suboccipital Release |
Suboccipital release technique
position: supine lying
intervention time: 4 minutes |
| Intervention |
Muscle Energy Technique |
Post Isometric Relaxation
Intervention time : 4 minutes
position: supine lying |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18- 50
2. Neck pain on VAS: 3-7
3. Both males and females |
|
| ExclusionCriteria |
| Details |
1.Signs of serious pathology (malignancy, inflammatory disorder, infection)
2. History of cervical spine surgery in 12 months
3. History of trauma or fractures in cervical spine
4. Signs of cervical myelopathy and radiculopathy
5. Congenital spinal deformities
6.Participants having difficulty in cognitive insufficiency |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
|
pre intervention,
post intervention: immediately and after 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inclinometer |
pre intervention,
post intervention: immediately and after 24 hours |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "71"
Final Enrollment numbers achieved (India)="71" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/09/2023 |
| Date of Study Completion (India) |
31/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/05/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present study aimed to study the effects of muscle energy technique versus suboccipital release technique on pain and neck range of motion in individuals with mechanical neck pain.
Studies using muscle energy techniques and suboccipital release techniques individually have shown improvement but very few studies compared these two techniques in symptomatic population and there is lack of evidence about effectiveness of subocciptal release as compared to muscle energy technique on reducing pain in individuals with mechanical neck pain. So this study intended to compare the effectiveness of suboccipital release versus muscle energy techniques on pain and neck range of motion in the patients having mechanical neck pain. Hypothesis of the study is effects of suboccipital release and muscle energy technique are equally effective on pain and neck range of motion in individuals with mechanical neck pain |