| CTRI Number |
CTRI/2024/01/061178 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the effects of strain counterstain technique with muscle energy technique on hip pain: a randomised controlled trial |
|
Scientific Title of Study
|
Comparison of Strain counterstrain technique versus Muscle energy technique on piriformis trigger point: A Randomised Controlled 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 |
Deepika |
| Designation |
Post Graduate Student |
| Affiliation |
Amar jyoti institute of physiotherapy |
| Address |
Amar Jyoti institute of physiotherapy Karkardooma, vikas marg, Delhi-110092
East
DELHI
110092
India |
| Phone |
8708365649 |
| Fax |
|
| Email |
deepikayadav4199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepika |
| Designation |
Post Graduate Student |
| Affiliation |
Amar Jyoti institute of physiotherapy |
| Address |
Amar Jyoti institute of physiotherapy Karkardooma, vikas marg, Delhi-110092
East
DELHI
110092
India |
| Phone |
8708365649 |
| Fax |
|
| Email |
deepikayadav4199@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika |
| Designation |
Post Graduate Student |
| Affiliation |
Amar jyoti institute of physiotherapy |
| Address |
Amar Jyoti institute of physiotherapy Karkardooma, vikas marg, Delhi-110092
East
DELHI
110092
India |
| Phone |
8708365649 |
| Fax |
|
| Email |
deepikayadav4199@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amar Jyoti institute of physiotherapy, vikasmarg, Karkardooma, delhi 110092 |
|
|
Primary Sponsor
|
| Name |
Amar Jyoti institute of physiotherapy |
| Address |
Vikas marg, karkardooma, Delhi-110092 |
| Type of Sponsor |
Other [self - funded] |
|
|
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 |
| Tarun kumar |
Amar jyoti institute of physiotherapy |
Second floor, physiotherapy department, Vikas marg, Karkardooma, Delhi-110092
East
DELHI |
8745802112
physiotarun29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar jyoti institutional review board-ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muscle Energy Technique |
Muscle energy technique will be given to each individual. With this procedure, the patient is asked to lie supine, with the affected sides knee bent and its foot placed on the lateral aspect of the other knee, while the therapist pushes the knee medially until it meets the restrictive barrier. Give the patient three to five seconds to push against the resistance of the therapist, then allow them a period of isometric relaxation before engaging a new barrier and repeating the process three times. |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Static stretching
|
Ask the patient to lie supine with his legs straight.
Instruct the patient to elevate the affected leg and flex the knee. Gently draw your knee toward your opposite shoulder with your other hand while you perform 10 repetitions x 3 sets of 10 seconds. |
| Intervention |
Strain counterstrain |
With the patient in a prone position, the therapist will palpate the trigger point, suspend the patients lower extremities off the plinth, flex the hip (around 135 degrees), abduct, and rotate the hip externally as needed until the patients pain subsides. The position is held for 90 seconds, and a 10-second rest period is given. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Grade -II tenderness on piriformis trigger point.
2.Positive Active piriformis test and Seated piriformis stretch test
3.Decreased medial/internal and external rotation of hip.
|
|
| ExclusionCriteria |
| Details |
1. Back and lower limb surgery
2. Spinal deformity
3. History of PIVD less than 6 months
4. Cross SLR positive
5. Slump positive
6. Spinal fracture
7. Spondylolisthesis
8. Arthritis
9. Amputation
10. Any pathology and injury around hip, knee
11. Ankylosing spondylitis
12. Pregnancy/post 1 year pregnancy
13. Lumbar stenosis.
|
|
|
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 |
1. Grade of tenderness of piriformis trigger points.
2. Hip internal and external range of motion |
Three time assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Active piriformis test
2.Seated piriformis stretch test |
Three time points |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/01/2024 |
| Date of Study Completion (India) |
29/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Present study is an interventional study. The purpose of the study is to compare strain counterstrain technique with muscle energy technique to explore the efficacy of these techniques in alleviating piriformis trigger points. Study will be conducted at Amar jyoti institute of physiotherapy (University of Delhi) in Delhi, India. The aim and objectives of the study are to identify the effect of Strain counterstrain technique versus muscle energy technique on piriformis trigger point, to investigate the efficacy of Strain counterstrain on piriformis trigger point, to investigate the efficacy of muscle energy technique on piriformis trigger point and to investigate the efficacy of strain counterstrain technique along with muscle energy technique on piriformis trigger point. The outcome measures are Grade of tenderness of piriformis trigger points, Hip internal and external range of motion. · |