CTRI Number |
CTRI/2023/01/049276 [Registered on: 30/01/2023] Trial Registered Prospectively |
Last Modified On: |
22/09/2025 |
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
|
Effect of exercise using Elastic band, Manual therapy technique and Stretching in hamstring muscle flexibility in Low back pain |
Scientific Title of Study
|
Effect of Eccentric training using Thera-band, Muscle energy technique and Static stretching in hamstring muscle flexibility of patients with mechanical Low back pain |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mohammed Aejaz Siddiqui |
Designation |
Lecturer |
Affiliation |
Khyati Institute of Physiotherapy |
Address |
Department of Physiotherapy, Khyati Institute of Physiotherapy,Shahibaug, Ahmedabad
Ahmadabad GUJARAT 380003 India |
Phone |
9173006095 |
Fax |
|
Email |
dr.aijaz00786@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Amalkumar Bhattacharya |
Designation |
Professor and head |
Affiliation |
Parul University |
Address |
Department of Medicine,
Parul University,
Waghodia, Vadoadara
Vadodara GUJARAT 391760 India |
Phone |
9824333430 |
Fax |
|
Email |
amal_akb@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Amalkumar Bhattacharya |
Designation |
Professor and head |
Affiliation |
Parul University |
Address |
Department of Medicine,
Parul University,
Waghodia, Vadoadara
Rajkot GUJARAT 391760 India |
Phone |
9824333430 |
Fax |
|
Email |
amal_akb@rediffmail.com |
|
Source of Monetary or Material Support
|
Dr.jivraj mehta healthe foundation, hospital, Jivrajpark,Bakeri Medical Research Centre, Dr Jivraj Mehta Marg, Paldi, Ahmedabad - 380007 (Near Ayojan Nagar, Lavanya Society, Yashkamal Society) Ahmedabad |
M.S Physiotherapy clinic, shop no. 8 shahin society complex, near juhapura cross road,sarkhej road, ahmedabad. |
|
Primary Sponsor
|
Name |
Mohammed Aejaz Siddiqui |
Address |
Parul University,vadodara, gujarat |
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 |
Dr M Aejaz M Siddiqui |
M.S. Physiotherapy and Pain Relief Center |
Physiotherapy Department, no.8, shahin society complex, near model school, juhapura sarkhej road, Ahmedabad Ahmadabad GUJARAT |
09173006095
dr.aijaz00786@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Dr.Jivraj Mehta Smarak health foundation, Institutional Ethics Commitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Dsiability |
By Oswetry Disability Index |
Comparator Agent |
Goniometry measurement techniques |
Active knee extension by 90-90 test |
Comparator Agent |
Pain |
by NPRS scale |
Intervention |
Physiotherapy technique
(Eccentric training with thera band)
|
Eccentric training with thera band, given for 3 days a week(frequency) for 6 weeks (total duration) |
Intervention |
Physiotherapy technique(Static hamstring stretching) |
Static hamstring stretching, given for 3 days week(frequency) for 6 weeks(total duration) |
Intervention |
physiotherapy techniques
(Muscle energy technique) |
muscle energy technique given for 3 days(frequncy) a week for 6 weeks(total duration) |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Subjects with mechanical low back pain
Tightness in hamstring muscle diagnosed with 90-90 test.
(Inability to achieve 20 degree of active knee extension in supine position.)
|
|
ExclusionCriteria |
Details |
Hyper mobility of knee joint.
Subjects under medication(muscle relaxants, corticosteroids).
Skin disease like skin ulcers and warts.
Open wounds and ulcers.
Neurological problems
Circulatory problems like arterial and venous disease.
Metal implants in the lower extremities
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Hamstring flexibility |
on intial assessment (Pre-intervention), after 3 weeks, after 6 weeks, after 8 weeks (follow-up) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pain |
on intial assessment (Pre-intervention), after 3 weeks, after 6 weeks, after 8 weeks (follow-up) |
Disability |
on intial assessment (Pre-intervention), after 3 weeks, after 6 weeks, after 8 weeks (follow-up) |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/02/2023 |
Date of Study Completion (India) |
25/09/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
25/09/2024 |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.aijaz00786@gmail.com].
- For how long will this data be available start date provided 26-01-2025 and end date provided 26-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
EFFECT OF ECCENTRIC TRAINING USING THERA-BAND,
MUSCLE ENERGY TECHNIQUE AND STATIC STRETCHING IN HAMSTRING MUSCLE FLEXIBILITY
OF PATIENTS WITH MECHANICAL LOW BACK PAIN
|