| CTRI Number |
CTRI/2026/03/105333 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| 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 Study to Compare Two Types of Exercise Therapy to Reduce Pain and Improve Movement in People with Knee Osteoarthritis. |
|
Scientific Title of Study
|
Effect of Trunk Stabilization Exercises Versus Localized Post Isometric Relaxation Technique on Pain, Physical Function and Range of Motion in Individuals with Knee Osteoarthritis: A Randomized Clinical 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 |
Dr Asmita PT |
| Designation |
STUDENT (MPT MUSCULOSKELETAL) |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),
Physiotherapy department,
Room number 21,
4 Vishnu Digamber Marg New Delhi 110002
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),
Physiotherapy department,
Room number 21,
4 Vishnu Digamber Marg New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9521795522 |
| Fax |
|
| Email |
asmitakumari128@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajni kalra PT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),
Physiotherapy department,
Room number 21,
4 Vishnu Digamber Marg New Delhi 110002
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),
Physiotherapy department,
Room number 21,
4 Vishnu Digamber Marg New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9599833554 |
| Fax |
|
| Email |
rajnikalra70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajni kalra PT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),
Physiotherapy department,
Room number 21,
4 Vishnu Digamber Marg New Delhi 110002
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),
Physiotherapy department,
Room number 21,
4 Vishnu Digamber Marg New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9599833554 |
| Fax |
|
| Email |
rajnikalra70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),4, Vishnu Digamber Marg, New Delhi-110002
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [ Rehabilitation Institute] |
|
|
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 Asmita PT |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
Department of Physiotherapy, Room no.21, 4, Vishnu Digamber Marg, New Delhi-110002
New Delhi
DELHI |
9521795522
asmitakumari128@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pandit Deendayal Upadhyaya National Institute for Person with Physical Disabilities |
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 |
Localised post isometric relaxation technique along with conventional exercises. |
for 4 sessions/week for 4 weeks. |
| Comparator Agent |
Trunk stabilisation exercises along with conventional exercises. |
for 4 sessions/week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female subjects of knee osteoarthritis
2. age group between 40-60
3. Kellgren and Lawrence radiological criteria grade 1 to 3
4. visual analogue scale 4 to 7
5. Body mass index less than 30 |
|
| ExclusionCriteria |
| Details |
1. Post-traumatic OA.
2. Lower limb sensorimotor deficit.
3. Non-specific symptoms (uncontrolled BP, malaise, weight loss and fever).
4. Recent intra-articular injection of any kind in the last six months.
5. Those using assistive devices for ambulation (sticks, walkers, and canes).
6. Severe joint deformity of the lower limb.
7. Patients with a history of hip OA, joint replacement in the lower limb, spine surgery, and inflammatory arthritis.
8. Subjects on medication for knee OA (NSAIDS) for the last 1 month.
9. Any other major joint pain (e.g. back, hip, ankle) that could limit functional ability.
10. Subjects who are undergoing any core or trunk stability training for the last 2 months.
11. Patients with other knee conditions, like knee ligamentous injury or sprain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 6-Minute Walk Test |
At baseline and after second and four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain |
At baseline and after second and four weeks |
| range of motions |
At baseline and after second and four weeks |
| 30 seconds sit to stands |
At baseline and after second and four weeks |
| Knee Injury and Osteoarthritis Outcome score (KOOS) |
At baseline and after second and four weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
17/03/2026 |
| 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)
|
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 is a common condition that causes knee pain, stiffness, and difficulty in daily activities. Physiotherapy is an important part of its management. This randomised clinical trial aims to compare the effects of trunk stabilisation exercises and localised post-isometric relaxation techniques on pain, physical function, and knee range of motion in individuals with knee osteoarthritis. Approximately 46 participants will be randomly divided into two groups. Both groups will receive conventional knee exercises and a moist hot pack for 4 weeks. Group A will receive trunk stabilisation exercises, while Group B will receive post-isometric relaxation techniques. Outcomes will be assessed before treatment, at 2 weeks, and after 4 weeks. The results of this study may help identify a more effective physiotherapy approach for managing knee osteoarthritis. |