| CTRI Number |
CTRI/2025/04/085811 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| 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
|
Effect of Hamstring Active Release Technique Program on knee Pain, Range of motion and Hamstring-to-Quadriceps strength ratio in patients with Knee Osteoarthritis |
|
Scientific Title of Study
|
Impact of Hamstring Active Release Technique Program on Pain, Range of motion and Hamstring-to-Quadriceps strength ratio in patients with Grade 1 and 2 Knee Osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satwinder Kaur |
| Designation |
Student |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University) |
| Address |
Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala HARYANA 133207 India |
| Phone |
8427669149 |
| Fax |
|
| Email |
satwinderkaurbpt2019@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sandeep Pattnaik |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University) |
| Address |
Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala HARYANA 133207 India |
| Phone |
9438565681 |
| Fax |
|
| Email |
physiosandeep94@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sandeep Pattnaik |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University) |
| Address |
Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala HARYANA 133207 India |
| Phone |
9438565681 |
| Fax |
|
| Email |
physiosandeep94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Satwinder Kaur |
| Address |
Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, HARYANA, India, 133207 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sandeep Pattnaik |
Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, HARYANA, India, 133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Satwinder Kaur |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Orthopedic Physiotherapy Research Laboratory, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, India, 133207 Ambala HARYANA |
8427669149
satwinderkaurbpt2019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Sciences and Research Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hamstring Active Release Technique
Interferential Therapy
Conventional exercise including Quadriceps isometric exercise, straight leg raise, hamstring set, bridging, heel rise |
Hamstring Active Release technique-30 seconds stretch for 5 repetitions per session for 3 sessions per week for 4 weeks
IFT-Carrier frequency 4khz, beat frequency 100hz, sweep frequency 150hz, 10 minutes per session, 3 sessions per week for 4 weeks
Exercise Protocol- Quadriceps isometric exercise, straight leg raising, hamstring set, bridging, heel rise 10 seconds hold, 10 repetitions each per session with 5 seconds rest in between. |
| Comparator Agent |
Interferential Therapy Conventional exercise including Quadriceps isometric exercise, straight leg raise, hamstring set, bridging, heel rise |
IFT-Carrier frequency 4khz, beat frequency 100hz, sweep frequency 150hz, 10 minutes per session, 3 sessions per week for 4 weeks
Exercise Protocol- Quadriceps isometric exercise, straight leg raising, hamstring set, bridging, heel rise 10 seconds hold, 10 repetitions each per session with 5 seconds rest in between. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with grade 1 and 2 knee osteoarthritis.
Willingness to participate and provide informed consent.
Ability to understand and follow instructions.
|
|
| ExclusionCriteria |
| Details |
Severe knee osteoarthritis grade 3 and 4.
Recent knee surgery or injury.
Any recent physiotherapy for knee osteoarthritis within last 3 months.
Neurological disorders affecting lower limbs.
Pregnancy or lactation.
Any other condition that may confound the results of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.NPRS for pain intensity
2.Universal Goniometry to measure Active and Passive knee Range of Motion
3.Hamstring-to-quadriceps strength ratio using Modified Sphygmomanometer test
|
At baseline (Immediately after recruitment)
After 4 weeks of intervention (!2 sessions of treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nil
|
Nil |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
15/05/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Knee
osteoarthritis also known as degenerative joint disease, is typically the
result of wear and tear of the articular cartilage. It may lead to muscle weakness,
increased joint loading, alteration in the gait pattern and increase the knee adduction movement. The
objective of the study is to determine
the impact of the Hamstring Active Release Technique (ART) program on range of
motion in patients with grade 1 and 2 knee osteoarthritis. Active release
technique is a manual therapy for the recovery of soft tissue function that
involve the removal of adhesions, which can cause pain, stiffness, and muscle
weakness. To
determine the impact of the Hamstring Active Release Technique (ART) program on
range of motion and the Isokinetic Hamstring to Quadriceps Strength Ratio in
patients with Grade 1 And 2 Knee Osteoarthritis. On the basis of inclusion and exclusion criteria. Subjects
will be randomly allocated into Group 1, Group 2 through computer based random
allocation techniques. Group 1 will receive Active release technique with
conventional physiotherapy treatment and Group 2 will receive only conventional
physiotherapy treatment. Pre-test and post-test assessment will be done by
Numerical Pain rating scale (NPRS), Goniometer to measure Active and Passive
range of motion and hamstring and quadriceps strength ratio using Sphygmomanometer
test. This research aligns with a patient-centered
approach, and a deeper understanding of the musculoskeletal health, and the
choice of additional physiotherapy treatment approaches. |