| CTRI Number |
CTRI/2024/12/078290 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Manual Traction Physiotherapy Can Help Improve Pain, Stiffness, and Physical Function in People with Knee Arthritis |
|
Scientific Title of Study
|
The impact of manual traction physiotherapy technique on The Western Ontario and Mcmaster University Osteoarthritis Index (WOMAC) and CTX-II Levels 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 |
Dedi Ardinata |
| Designation |
Investigator |
| Affiliation |
Department of Physiology, Faculty of Medicine Universitas Sumatera Utara. |
| Address |
Department of Physiology, Faculty of Medicine Universitas Sumatera Utara.
Jl. Dr. Mansur no. 5. Pada bulan, Medan, Sumatera Utara, Indonesia
20155
Other |
| Phone |
085262915879 |
| Fax |
|
| Email |
dedi1@usu.ac.id |
|
Details of Contact Person
Scientific Query
|
| Name |
Dedi Ardinata |
| Designation |
Investigator |
| Affiliation |
Department of Physiology, Faculty of Medicine Universitas Sumatera Utara. |
| Address |
Department of Physiology, Faculty of Medicine Universitas Sumatera Utara.
Jl. Dr. Mansur no. 5. Pada bulan, Medan, Sumatera Utara, Indonesia
20155
Other |
| Phone |
085262915879 |
| Fax |
|
| Email |
dedi1@usu.ac.id |
|
Details of Contact Person
Public Query
|
| Name |
Rizka Mutiara |
| Designation |
Investigator |
| Affiliation |
Masters Program in Biomedical Science, Faculty of Medicine, Universitas Sumatera Utara |
| Address |
Masters Program in Biomedical Science, Faculty of Medicine, Universitas Sumatera Utara
Jl. Dr. Mansur no. 5. Pada bulan, Medan, Sumatera Utara, Indonesia
Jl. Dr. Mansur no. 5. Pada bulan, Medan, Sumatera Utara, Indonesia
20155
Other |
| Phone |
082168982575 |
| Fax |
|
| Email |
rizkamutiara1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Medicine, Universitas Sumatera Utara
Jl. Dr. Mansur no. 5. Pada bulan, Medan, Sumatera Utara, Indonesia,20155 |
|
|
Primary Sponsor
|
| Name |
Faculty of Medicine Universitas Sumatera Utara |
| Address |
Jl. Dr. Mansur no. 5. Pada bulan, Medan, Sumatera Utara, Indonesia. 20155 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Indonesia |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Wenti Damayanti Gea |
RSU. Sembiring (General Hospital) |
Physiotherapy & rehabilitation services.
Jalan Besar No. 77 Kec. Delitua Kab. Deli Serdang Sumatra Utara
|
082277306287
wentygea722@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Komite-Etik-Penelitian-Kesehatan-Universitas-Sumatera-Utara-(University-Research-Ethics-Committee) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
manual traction physiotherapy technique |
Standard Operating Procedures for Manual Traction Implementation
Understanding
Manual traction is the movement of a joint surface perpendicular to the joint surface of its partner towards a distance, accompanied by a form of passive movement with a small or large amplitude.
Purpose
Abnormal release of licrosslinks in the joint capsule
Reduces the viscosity of knee joint fluid
Reduces pain
Releasing the adhesion of the ligamentous capsule knee joint
Maintains muscle elasticity
Improves blood circulation
Procedure
The procedure for implementing manual traction carried out by the author in this study is as follows:
Preparation of Tools/Beds
The physiotherapist checks the cleanliness and position of the bed.
The height is low according to the therapists ergonomics.
Belt or belt
Physiotherapist Preparation
The physiotherapist checks the cleanliness and position of the bed.
All distracting accessiories are removed (rings, watches).
Patient Preparation
Physiotherapy explains the purpose, procedure and implementation of manual traction.
The patient is face down, the knee joint position forms 450 and is free from clothing, then the patient is attached to a belt ± 3 fingers above the knee joint.
Management
The physiotherapy hand fixes with a lumbrical grip or holds the patients leg slightly above the ankle with the patient in a prone position and knee flexion.
The patient is instructed to relax.
Then the physiotherapist performed a pull on the patients leg straight with ±.45-0. Then relax and repeat the above movements.
Manual traction Dosage technique applied:
Intensity : Perform 3 repetitions
Duration : 8 to 10 seconds
Frequency: 2 times a week for 4 weeks of research. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Men and women over 40 years old.
Diagnosed with bilateral knee osteoarthritis (OA) by a qualified doctor.
Have not previously received physiotherapy for knee OA.
Have a moderate severity of knee OA (Grade 3).
Able to answer questions clearly (no cognitive impairments).
No other bone or muscle disorders. |
|
| ExclusionCriteria |
| Details |
Taking medications like immune system suppressors, corticosteroids, cyclosporins, antipsychotics, or any osteoarthritis drugs, including pain relievers taken by mouth, injection, or applied to the skin (like NSAIDs).
Unable to follow the full research protocol.
Receiving other medical or traditional treatments for knee osteoarthritis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The main outcomes of this study are the change in the WOMAC score and the levels of CTX-II. |
The main outcome of this study will be assessed at baseline and immediately after the last manual traction session (session 8) in the fourth week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of this research is side effects of manual traction intervention |
The side effects of manual traction intervention are assessed 5–15 minutes after each intervention. |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
03/01/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dedi1@usu.ac.id].
- For how long will this data be available start date provided 28-02-2025 and end date provided 31-03-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - N/A
|
|
Brief Summary
|
This study aims to evaluate the effects of a physiotherapy technique known as manual traction on patients with knee osteoarthritis (OA). The focus is on two key outcomes: improvement in knee pain, stiffness, and function, measured by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and levels of CTX-II, a marker for cartilage breakdown. By comparing these measurements before and after the therapy, the study seeks to determine if manual traction can provide relief and slow cartilage deterioration in knee OA patients |