| CTRI Number |
CTRI/2025/12/099185 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Electro-Acupuncture Treatment for knee pain |
|
Scientific Title of Study
|
Clinical Outcome of Electro-Acupuncture in the Management of Knee Bi Syndrome:An Acupuncture And Energy Medicine Based Randomized Controlled 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 Dinesh kumar S |
| Designation |
PG scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences Faculty Block Ground FloorRoom No 3 Kamaraja Nagar
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379938973 |
| Fax |
|
| Email |
kumar02012000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Geetanjali |
| Designation |
Head of the Department of Acupuncture and Energy Medicine (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences,Faculty Block, Ground Floor,Room No.3,Department of Acupuncture
and Energy Medicine,Division III,Kamaraja Nagar,Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Geetanjali |
| Designation |
Head of the Department of Acupuncture and Energy Medicine (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences,Faculty Block, Ground Floor,Room No.3,Department of Acupuncture
and Energy Medicine,Division III,Kamaraja Nagar,Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences. |
|
|
Primary Sponsor
|
| Name |
Dr Dinesh kumar S |
| Address |
184/4 INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY, FACULTY BLOCK, Ground Floor, Room No. 3,KAMARAJA
NAGAR,CHENGALPATTU,Kancheepuram,TAMIL NADU - 603001,India |
| Type of Sponsor |
Other [Self] |
|
|
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 Dinesh kumar S |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4,Acupuncture and Energy Medicine Division,Faculty
Block,Ground Floor,Room No.2,Kamaraj Nagar,Chengalpattu.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
6379938973
kumar02012000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee International Institute of Yoga and Naturopathy Medical Sciences |
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 |
Electroacupuncture |
The study group will receive electroacupuncture at six specific TCM acupoints:MEDIAL XIYAN(Medial-eye of the knee),SP5(Shangqiu),SP9(Yinlingquan),ST35(Dubi),ST36(Zusanl)and GB34(Yanglingquan).Sterile, single-use acupuncture copper handled filiform needles (0.25 × 25 mm) will be inserted perpendicularly to a depth of 15–25 mm to the patients in a sitting position. Electrical stimulation will be done with a Electronic Acupuncture instrument having an adjustable pulse frequency between 1 – 100 Hz.The above points are given for 20 minutes for each session - three sessions in a week alternatively for three consecutive weeks. |
| Comparator Agent |
Waitlist |
The patient will be rested during treatment for 3 week study.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients were diagnosed with knee pain (symptoms - pain, swelling,warm,stiffness).2.The participants who have the range of motion (ROM) below 130°.3.Body mass index (BMI)lesser than 35.4.The participants are included under the TCM based knee bi syndrome questionaries (Bothmoderate and severe). |
|
| ExclusionCriteria |
| Details |
1.Patients with severe osteoarthritis requiring surgical intervention or history of lower-limbjoint (knee joint) arthroplasty surgery.2.Presence of other diseases causing pain or dysfunction of the lower limb, apart from kneejoint disease. (Lumbar disc herniation, Parkinson’s disease, Alzheimer’s disease, Neuromuscular disorder, etc.)3.Patients who had undergone any cardiovascular surgery (coronary stent or pacemaker)or epilepsy.4.Patients with Psychiatric conditions such as Schizophrenia or Depression.5.Pregnant or lactating women.6.Patients who are afraid of needles (Trypanophobia) & disorders of coagulopathy(e.g., hemophilia).7.Individuals who are undergoing chemotherapy sessions.8.Participation in another clinical study within the last 30 days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Range of Motion (ROM): Assessed using a universal goniometer to measure knee flexion and extension.2.Assessment of TCM Knee Bi Syndrome Assessment Questionnaire (TCM-KBSAQ) before and after the intervention. |
Baseline, 1st week and 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Pain related disability: Will be measured by using the Pain Disability Index(PDI) score.2.Inflammatory marker (ESR): By lab investigation. |
Baseline,1st week and 3rd week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/01/2026 |
| 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="1"
Months="1"
Days="30" |
|
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
|
This study is a randomized controlled trial evaluating the effectiveness of electro-acupuncture in treating Knee Bi Syndrome, a TCM condition caused by obstruction of qi and blood due to cold-damp invasion. The research aims to measure improvements in knee range of motion, pain severity, disability, and inflammatory markers after treatment. Seventy participants aged 35–60 will be selected based on both clinical and TCM diagnostic criteria. The intervention group receives electro-acupuncture at six specific acupoints for 20 minutes, three times weekly for three weeks, while the control group receives no treatment during the study. Key outcome tools include a goniometer, the TCM Knee Bi Syndrome Assessment Questionnaire, the Pain Disability Index, and ESR testing. Randomization is done using computerized allocation and SNOSE concealment, though blinding is not used. Ethical considerations, informed consent, and participant confidentiality are comprehensively addressed. The document includes detailed methodology, inclusion and exclusion criteria, and standardized treatment procedures. A literature review highlights prior evidence showing electro-acupuncture’s analgesic and anti-inflammatory benefits. Overall, the study seeks to generate reliable evidence supporting electro-acupuncture for chronic knee pain within a TCM framework. |