| CTRI Number |
CTRI/2025/12/099665 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| 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 integrated PNF exercises on reducing pain and stiffness and improving daily life in people with knee osteoarthritis. |
|
Scientific Title of Study
|
Efficacy of integrated proprioceptive neuromuscular facilitation technique in reducing pain and tightness and improving quality of life in patients with 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 |
Dr Sunita Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,MMDU,Mullana,Ambala, Haryana, 133207, India |
| Address |
Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR), Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, 133207, India
Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR), Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, 133207, India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Gourab Deb |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,MMDU,Mullana,Ambala |
| Address |
Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR), Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, 133207, India
Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR), Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, 133207, India
Ambala
HARYANA
133207
India |
| Phone |
8787852389 |
| Fax |
|
| Email |
gaurabdeb71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gourab Deb |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,MMDU,Mullana,Ambala |
| Address |
Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR), Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, 133207, India
Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR), Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, 133207, India
Ambala
HARYANA
133207
India |
| Phone |
8787852389 |
| Fax |
|
| Email |
gaurabdeb71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MMDU, Mullana, Ambala, 133207, INDIA |
|
|
Primary Sponsor
|
| Name |
Gourab Deb |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MMDU, Mullana, Ambala |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gourab Deb PT |
MM Super specialty Hospital, Mullana, 133207, Ambala, Haryana, India. |
Ground floor, Room no. 2, Department of Physiotherapy, Maharishi Markandeshwar (deemed to be a university), Mullana, 133207, Ambala, Haryana, India.
Ambala
HARYANA |
8787852389
gaurabdeb71@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Treatment |
The conventional treatment protocol includes gentle stretching and isometric strengthening targeting hamstrings, quadriceps, adductors, abductors, the IT band, and calf muscles. Sessions last 30–50 minutes, 3 times weekly for 4 weeks. The protocol progresses weekly from basic stretches to mini squats, heel-to-toe walking, and balance tasks through gradual progression with increasing repetitions and duration |
| Intervention |
Integrated PNF Technique |
Integrated PNF protocol involves hold-relax stretching and a combination of isotonic techniques. It primarily targets hamstrings, quadriceps, adductors, abductors, the IT band, and calf muscles. Each session lasts 25–50 minutes, with weekly variation in repetitions and duration for hold-relax stretching and COI. Each session is conducted 3 times per week, over 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 40 and 70 years.
2. Both males and females will be included.
3. Patients with Grade 1, 2, or 3 osteoarthritis of the knee using the Kellgren-Lawrence classification.
4. Presence of joint osteoarthritis in one or both knees confirmed by radiographic x-ray.
|
|
| ExclusionCriteria |
| Details |
1. knee joint pathologies, e.g., chondromalacia patella, plica syndrome.
2. Post-traumatic knee patients.
3. No history of surgery on the target joint (such as joint replacement or repair).
4. Patients with intra-articular contracture were excluded from 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. The Western Ontario and McMaster Universities Arthritis Index (WOMAC).
2. Universal Goniometer.
3. Pain intensity measured using the Visual Analog Scale (VAS).
|
Pre & post (4 week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Quality of Life: Measured with SF-36 questionnaire. |
Pre & post (4 week) |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Osteoarthritis is one of the most common musculoskeletal disorders, and among that, knee osteoarthritis is the most common type of arthritis. According to data from the Global Burden of Disease, the prevalence of knee pain increases with age, with the highest prevalence in individuals over the age of 50. The osteoarthritis can cause various anatomical and physiological changes in joint tissues, such as cartilage degradation, bone regeneration, and the development of osteophytes. Osteoarthritis is recognized as the most common joint disorder, and from 1990 to 2019, the global prevalence of KOA increased by 48%. The purpose of this study is to evaluate the effects of the integrated PNF technique on pain levels, functional mobility, muscle strength, muscle tightness, and overall quality of life in patients with knee osteoarthritis. Patients will be recruited based on selection criteria. Subjects will be randomly allocated into group A and group B. Group A will receive the integrated PNF approach, and Group B will receive conventional treatment. Pre-test and post-test assessments will be done by using a goniometer, WOMAC, quality of life with SF-36, & VAS for pain. There is no literature that evaluates the effect of integrated PNF technique on pain levels, functional mobility, muscle strength, muscle tightness, and overall quality of life in patients with knee osteoarthritis. |