| CTRI Number |
CTRI/2025/02/080128 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Acupressure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Benefit of Acupressure for Joint Pain and Mobility in Knee Osteoarthritis |
|
Scientific Title of Study
|
Effectiveness of Acupressure on Pain, Joint Stiffness, and Physical Function in Patients with Osteoarthritis of Knee |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nafi Yannis |
| Designation |
Investigator |
| Affiliation |
Magister of Nursing, Faculty of Nursing Universitas Sumatera Utara |
| Address |
Magister of Nursing Department, Medical Surgical Nursing Division on Second Floor, Room no. 3, Faculty of Nursing Universitas Sumatera Utara
Jl. Prof. T. Maas No.3, Kampus, Padang Bulan, Medan, Sumatera Utara,
Indonesia
20155
Other |
| Phone |
082160435355 |
| Fax |
|
| Email |
nafiyannis@usu.ac.id |
|
Details of Contact Person
Scientific Query
|
| Name |
Nafi Yannis |
| Designation |
Investigator |
| Affiliation |
Magister of Nursing, Faculty of Nursing Universitas Sumatera Utara |
| Address |
Magister of Nursing Department, Medical Surgical Nursing Division on Second Floor, Room no. 3, Faculty of Nursing Universitas Sumatera Utara
Jl. Prof. T. Maas No.3, Kampus, Padang Bulan, Medan, Sumatera Utara,
Indonesia
20155
Other |
| Phone |
082160435355 |
| Fax |
|
| Email |
nafiyannis@usu.ac.id |
|
Details of Contact Person
Public 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. Padang bulan, Medan, Sumatera Utara, Indonesia
20155
Other |
| Phone |
085262915879 |
| Fax |
|
| Email |
dedi1@usu.ac.id |
|
|
Source of Monetary or Material Support
|
| Faculty of Nursing Universitas Sumatera Utara Jl. Prof. T. Maas No.3, Kampus, Padang Bulan, Medan, Sumatera Utara, 20155, Indonesia |
|
|
Primary Sponsor
|
| Name |
Faculty of Nursing Universitas Sumatera Utara |
| Address |
Jl. Prof. T. Maas No.3, Kampus, Padang Bulan, Medan, Sumatera Utara, 20155, Indonesia |
| Type of Sponsor |
Other [Government nursing 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 Tari Mediyanti |
Prof. Dr. Chairuddin P. Lubis Universitas Sumatera Utara (Governance Hospital) |
Physical Medicine and Rehabilitation Department, Division of
Physiotherapy and Rehabilitation services, first floor.
Jl. Dr. Mansyur No.66, Medan, 20155, Sumatera Utara, Indonesia
|
08126511707
tari.mediyanti@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: M15-M19||Osteoarthritis, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physiotherapy and NSAID |
Physiotherapy administered for three times a week for four weeks. NSAID (tab diclofenac 50 mg twice a day for less than 1 week) |
| Intervention |
Physiotherapy, NSAID, and Acupressure |
Physiotherapy administered for three times a week for four weeks. NSAID (tab diclofenac 50 mg twice a day for less than 1 week) plus Acupressure administered for patients in eight acupressure points on the knee: ST34, ST35, ST36, SP9, SP10, GB34, EX-LE2, and EX-LE4. Acupressure dosage technique applied: Intensity : Perform 3 repetition duration : 10 to 15 seconds Frequency : 3 times a week for 4 weeks of research. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of diagnosed with osteoarthritis in one knee by a competent physician
Patients with unilateral or bilateral knee x-rays.
Patients has not undergone any acupressure treatment related to knee osteoarthritis.
Patients does not have any other musculoskeletal disorders.
Patients has not received intra-articular injections within the past 30 days.
Patients has no history of knee surgery.
Patients WOMAC score indicates moderate severity (24-48) in one knee.
Patients has not received physiotherapy before.
Patients has been prescribe NSAIDs for less than one week.
Patients does not experience cognitive impairment that would hinder answering question.
Patients able to speak Indonesian.
|
|
| ExclusionCriteria |
| Details |
Patients unwilling to adhere to the research standards until completion
Patients has received traditional interventions for knee osteoarthritis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The main outcome of this study are the change in Western Ontario and Macmaster Universities Osteoarthritis Index (WOMAC) score |
The main outcome of this study will be assessed at baseline 2 week and 4 week. Immediately after first week, after second week, after third week, and after the last acupressure session (session 3) in the fourth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of this research is side effects of acupressure intervention |
The side effects of acupressure intervention are assessed at baseline in 15 minutes after each intervention |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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-identiļ¬cation.
- 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 [nafiyannis@usu.ac.id].
- For how long will this data be available start date provided 03-03-2025 and end date provided 03-06-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Osteoarthritis causes symptoms of pain, joint stiffness, and decrease physical function. Management of osteoarthritis is commonly approached through pharmacological and surgical interventions, which are often associated with side effect. Acupressure offers an alternative for managing chronic pain condition such as osteoarthritis, with advantages including low cost, minimal complications, simple applications, and higher safety. Study aims to evaluate the effect of acupressure in patients with knee osteoarthritis. The focus on primary outcome to improvement in knee pain, stiffness, and function measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). By comparing these measurements before acupressure, after 1 week, after 2 week, after 3 week, and after 4 week. The study seeks to determine whether acupressure can release of endorphins as body natural painkiller and trigger anti-inflammatory response to reduce swelling in patients with osteoarthritis of knee.
|