| CTRI Number |
CTRI/2024/12/077686 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Developing a questionnaire which help Physiotherapist to treat individuals with Knee pain |
|
Scientific Title of Study
|
Development, Validation, and Effectiveness of the SRIHER Knee Pain Screening Tool with Targeted Therapy in Physiotherapy Primary Care: A Randomized Controlled 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 |
Soundararajan K |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical Rehabilitation Department, Ground Floor, New block, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, [Deemed to be university], Porur, Chennai, INDIA.
Ramachandra Medical College, Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
09551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr P Antony Leo Aseer |
| Designation |
Professor and Principal |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical Rehabilitation Department, Ground Floor, New block, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, [Deemed to be university], Porur, Chennai, INDIA.
Ramachandra Medical College, Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
09841544303 |
| Fax |
|
| Email |
antonyleo@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr P Antony Leo Aseer |
| Designation |
Professor and Principal |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical Rehabilitation Department, Ground Floor, New block, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, [Deemed to be university], Porur, Chennai, INDIA.
Ramachandra Medical College, Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116
TAMIL NADU
600116
India |
| Phone |
09841544303 |
| Fax |
|
| Email |
antonyleo@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, No 1, Sri Ramachandra Nagar, Porur, Chennai 600116, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu |
| 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 K Soundararajan |
Sri Ramachandra Hospital |
Physical Rehabilitation Department, Ground Floor, New block, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, [Deemed to be university], Porur, Chennai, INDIA.
Chennai
TAMIL NADU |
09551163416
soundararajan.k@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH INSTITUTIONAL ETHICS COMMITTEE Clinical Evaluation of Drugs Procedures Devices Diagnostics Vaccine Herbal remedies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M239||Unspecified internal derangement of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
The subjects in this group will receive knee-strengthening exercises in specific. Exercise will be progressed gradually according to ACSM guidelines. All exercises will be prescribed according to FITT Principles. |
| Intervention |
Experimental Group |
The subjects in this group will receive exercise based on the Delphi study recommendation, SRIHER Targeted Therapy. SRIHER Targeted Therapy is a comprehensive assessment and treatment for individuals with Knee Pain. Exercise will progress based on improvement. All exercises will be prescribed according to FITT Principles. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
-Participants with Knee Pain aged above 18 to 55 years
-Participants with sufficient English language comprehension
-Participants who gave consent to participate in the study |
|
| ExclusionCriteria |
| Details |
-Participants with severe knee OA, in whom knee replacement is indicated.
-Participants with a history of hip OA, lower limb joint replacement/ surgery, spine surgery
-Participants with corticoid injection within the past one month.
-Participants with any congenital or acquired deformity in the spine or lower limb
-Participants Diagnosed with comorbidities - neurological conditions, psychiatric conditions, systemic diseases/cancer
-Participants not able to come for follow ups / not willing to participate in the study
-Participants with suspicion of chronic widespread pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
30-Second Chair Stand Test
|
at Baseline, at the end of the 1st week, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Global perceived effect
Numerical rating scale
Patient Reported Outcomes Measurement Information System (PROMIS)
Knee muscle group strength using a hand-held dynamometer
|
at Baseline, at the end of the 1st week, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
18/12/2024 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
BACKGROUND According to estimates from the World Health Organization, 9.6% of men and 18% of women worldwide have symptomatic osteoarthritis in their older years. According to United Nations research, by 2050, over 20% of the world’s population will be over 60 years old. Individuals with Knee osteoarthritis (KOA) experience pain and disability more frequently than any other chronic health condition. Although knee osteoarthritis is a complex condition, it usually consists of unified subgroups or phenotypes. Therapeutic exercise is strongly advised in addition to diet and pain medication as the initial course of treatment. OA knee pain is difficult to diagnose in primary care, and both patients and healthcare professionals may find it irritating that there isn’t a well-established biological model and stratified rehabilitation program to support the pain and guide first physical therapy choices. They lack consideration of biological, psychological, and social interventions. We aimed to develop and validate an SRIHER knee pain screening and targeted therapy tool to identify prognostic indicators relevant to physical therapists’ clinical decision-making concerning initial treatment options in physiotherapy primary care. Also, to find the effectiveness of the SRIHER knee pain screening and targeted therapy tool on enhancing the outcomes among musculoskeletal knee pain individuals in physiotherapy primary care. There are minimal numbers of studies available globally with stratified rehabilitation programs addressing musculoskeletal knee pain and impairments. No study has been conducted with a randomized controlled trial design for a stratified knee rehabilitation program. AIM OF THE STUDY This study aims to develop a valid tool to screen, categorize, and deliver targeted therapy to individuals with musculoskeletal knee pain. To evaluate the effectiveness of the SRIHER knee pain screening tool with targeted therapy on enhancing the outcomes among musculoskeletal knee pain individuals in physiotherapy primary care using physical function.
|