| CTRI Number |
CTRI/2024/10/075911 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| 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
|
To Compare Effect of Two Techniques in Individuals with Neck Pain |
|
Scientific Title of Study
|
Comparative Effectiveness of Instrument Assisted Soft Tissue mobilization and Muscle Energy Technique on Posture and Pain in Individuals with Chronic Mechanical 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 |
Meera Gupta |
| Designation |
Post Graduate Student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injury Center - Institute of Rehabilitation sciences |
| Address |
Room no 6, 2nd floor, Indian Spinal Center - Institute of Rehabilitation Sciences (Musculoskeletal), Sector C, Vasant Kunj, New Delhi
South West DELHI 110070 India |
| Phone |
9354939714 |
| Fax |
|
| Email |
meeragupta0523@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chitra Kataria |
| Designation |
Professor and Principal |
| Affiliation |
Indian Spinal Injury Center - Institute of Rehabilitation sciences |
| Address |
Secretariate, 2nd floor, Indian Spinal Center - Institute of Rehabilitation Sciences (Musculoskeletal), Sector C, Vasant Kunj, New Delhi
South West DELHI 110011 India |
| Phone |
9810310670 |
| Fax |
|
| Email |
rehab@isiconline.org |
|
Details of Contact Person Public Query
|
| Name |
Meera Gupta |
| Designation |
Post Graduate Student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injury Center - Institute of Rehabilitation sciences |
| Address |
Room no 6, 2nd floor, Indian Spinal Center - Institute of Rehabilitation Sciences (Musculoskeletal), Sector C, Vasant Kunj, New Delhi
South West DELHI 110070 India |
| Phone |
9354939714 |
| Fax |
|
| Email |
meeragupta0523@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre - Institute of rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi, South West Delhi, 110070, India |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
N/A |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Meera Gupta |
Indian spinal Injuries Center Institute of Rehabilitation Sciences |
Rehabilitation Department, Ground Floor, Sector C, Vasant Kunj, New Delhi-110070 South West DELHI |
9354939714
meeragupta0523@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Indian Spinal Injuries Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrument Assisted Soft Tissue Mobilization |
Instrument Assisted Soft Tissue Mobilization will be given manually in combination with conventional therapy for 2 sessions over the course of 2 weeks |
| Comparator Agent |
Muscle Energy Technique |
Muscle Energy Technique will be given manually in combination with conventional therapy for 2 sessions over the course of 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-40 years, Chronic mechanical neck pain (more than 3 months), Craniovertebral Angle (CVA) less than 48 degrees, willingness to participate |
|
| ExclusionCriteria |
| Details |
patient diagnosed with any recent surgery, trauma or unhealed fracture of cervical spine, cervical spine surgery. patient diagnosed with neck pain secondary to disorders (like neoplasm, cardiovascular disease, spasmodic torticolis, radiculopathy with neurological deficits), systemic diseases (like infection or inflammatory arthritis of cervical spine). any open wound around neck, skin conditions (like petechie, ecchymosis), allergy to metal emolients, anti-coagulant therapy, patient intolerance and hypersensitivity to pain. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale |
Day 0 (baseline, Pre-test), at 2 week (Post-test) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain Pressure Threshold |
Day 0 (baseline, Pre-test), at 2 week (Post-test) |
| Craniovertebral Angle |
Day 0 (baseline, Pre-test), at 2 week (Post-test) |
| Cervical Range of Motion |
Day 0 (baseline, Pre-test), at 2 week (Post-test) |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
31/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="7" 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
|
Pain in the anatomic region of neck is known as mechanical neck pain which is primarily caused by overuse of a normal anatomical structure, secondary to injury and deformity of anatomical structure. Existing literature shows effectiveness of both the techniques on chronic mechanical neck pain as instrument assisted soft tissue mobilization with the help of specialized instrument apply strokes which releases muscle tension and improve flexibility. Whereas muscle energy technique works on the principle of post-isometric relaxation by which relaxes and further lengthen muscles. Both techniques are found effective in treating chronic mechanical neck pain separately. However, to best of our knowledge no study has checked comparative effectiveness of the two effective techniques. Patients will be screened based on inclusion and exclusion criteria and then they will be enrolled into 2 groups with the help of random allocation software. (Group 1) will receive instrument assisted soft tissue mobilization along with conventional physiotherapy. (Group 2) will receive muscle energy technique along with conventional physiotherapy for 4 sessions in course of 2 weeks. The outcome measurement will be done by numeric pain rating scale for pain, algometer for Pain Pressure threshold, Craniovertebral angle for forward head posture and Goniometer for cervical range of motion. Variations in the pre and post outcome measure will help us to find out which technique is more effective. |