| CTRI Number |
CTRI/2024/10/075078 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| 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
|
A clinical trial to test two method post-facilitation stretching and post-isometric relaxation to see which one better helps with neck movement and pain in people with neck pain. |
|
Scientific Title of Study
|
A STUDY TO COMPARE EFFECTIVENESS OF POST ISOMETRIC RELAXATION TECHNIQUE VS POST FACILITATION STRETCH TECHNIQUE IN IMPROVING RANGE OF MOTION AND PAIN IN NON SPECIFIC NECK PAIN A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dubey karishma satyaprakash |
| Designation |
MPT 1st YEAR (MSK) |
| Affiliation |
Narayana hrudayalaya institute of physiotherapy |
| Address |
Narayana Hrudayalaya Institute Of Physiotherapy,258/A, Hosur Road Anekal-Taluk, Bommasandra Industrial Area.
NH Health International Wing room no- 103
Bangalore
KARNATAKA
560099
India |
| Phone |
9987180738 |
| Fax |
|
| Email |
Karishmadu99@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr.Smruti Swagatika Dash |
| Designation |
Professor |
| Affiliation |
|
| Address |
Narayana Hrudayalaya Institute Of Physiotherapy,258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area.
NH Health International Wing room no- 103
Bangalore
KARNATAKA
560099
India |
| Phone |
9448552026 |
| Fax |
|
| Email |
ssdashpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dubey Karishma Satyaprakash |
| Designation |
MPT 1st YEAR (MSK) |
| Affiliation |
Narayana hrudayalaya institute of physiotherapy |
| Address |
Narayana Hrudayalaya Institute Of Physiotherapy,258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area.
NH Health International Wing room no- 103
Bangalore
KARNATAKA
560099
India |
| Phone |
9987180738 |
| Fax |
|
| Email |
Karishmadu99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Hrudayalaya Institute Of Physiotherapy,NH Health International Wing,258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area, Bengaluru, Karnataka 560099 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Dubey Karishma Satyaprakash |
Narayana Hrudayalaya Institute Of Physiotherapy |
258/A, NH Health International Wing room no- 103, Hosur Road Anekal-Taluk, Bommasandra Industrial Area.
NH Health International Wing room no- 103
Bangalore
KARNATAKA |
9987180738
Karishmadu99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academics Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post facilitation stretch technique |
This group with 34 participants will undergo post facilitation stretch technique for the upper fibers of trapezius, levator scapulae, sternocleidomastoid, scalene and suboccipital muscles instead of passive stretching. PFS technique will be applied to the patient, the patient would lie down with one hand on the shoulders point on the affected side. The patients head will be supported by the opposite arm while being flexed, laterally turned away from, and rotated towards the side of involvement. The muscle will be kept in a neutral posture throughout. The patient would contract the muscle strongly by pushing up against the therapists hand as if trying to shrug. This contraction will be held for 10 seconds, after which the patient relaxes and a fast stretch would be applied to the muscle by carefully moving the shoulder straight to the inferior ward. Holding the stretch for 10-15 seconds and repeating it for 3-5 times.This procedure should be repeated three times for each muscle bilaterally.The range of motion, pain and neck function will be assessed at baseline and after 4 weeks that is pre- and post- intervention.
|
| Comparator Agent |
Post isometric relaxation technique |
This group with 34 participants will undergo post isometric relaxation technique for the upper fibers of trapezius, levator scapulae, sternocleidomastoid, scalene and suboccipital muscles instead of passive stretching which is a ‘hands-on’ therapy to induce muscle stretching and relaxation. It is a rehabilitative therapeutic option for non-specific neck pain with the aim to restore normal joint mobility and reduce pain. It is effective in subsequent reduction in muscle , or group of muscles after a brief period during which an isometric contraction would be performed. This technique will be applied from a supine lying position with the head free from the plinth and held by the therapist’s hand while the therapist will be sitting on a stool at the head of the treatment table. The patients head will initially be positioned so that the stretched muscle is in a lengthened position, the therapist will apply isometric resistance to the action of the tight muscle and held for 7 seconds with gentle muscle contraction to avoid the risk of increasing the muscle tone, while breathing in with hold his/her breath during contraction, then the patient will be asked to breathe out and relax for 3 seconds, then apply static stretching in the opposite direction for 30 sec. The procedure will be repeated three times for each muscle bilaterally.The range of motion, pain and neck function will be assessed at baseline and after 4 weeks that is pre- and post- intervention.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-40 yrs.
Neck pain since 2-6 weeks
Both gender included
VAS pain intensity
NDI-neck disability index .
History of neck pain ,decreased cervical ROM included.
|
|
| ExclusionCriteria |
| Details |
Age less than 18 yrs.
History of trauma or accidental injuries.
Any serious pathology.
History of surgery on cervical region .
Existence of disc prolapse,tumor in cervical spine , whiplash injury.
Mental disorders.
Tumors / Malignancies.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck disability index -NDI
ACUTE TO CHRONIC |
BEFORE AND AFTER 4 WEEKS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale (VAS)
score 0 to 10 that is no pain to worst pain |
Before and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/10/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
This study is a randomized, parallel group trial comparing the post facilitation stretch technique and post isometric relaxation technique for 4weeks in patients with non specific neck pain that will be conducted in India. The primary outcome measures will be VAS, NDI and Goniometer for 4 weeks. |