| CTRI Number |
CTRI/2024/05/066885 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating Meridian Balance and Electro-Acupuncture: A Randomized Control Trial on Chronic Knee Pain |
|
Scientific Title of Study
|
Comparative study of the immediate effect of meridian balance method and electro-acupuncture for individuals with chronic knee pain-a randomized control 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 Abitone V R |
| Designation |
Assistant professor |
| Affiliation |
SDM College of Naturopathy And Yogic Sciences |
| Address |
Department of acupuncture,
SDMCNYS,Belthangady, Dakshina Kannada, Ujire, Karnataka 574240
SDMCNYS,Belthangady, Dakshina Kannada, Ujire, Karnataka 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9655976897 |
| Fax |
|
| Email |
abitone.avr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Abitone V R |
| Designation |
Assistant professor |
| Affiliation |
SDM College of Naturopathy And Yogic Sciences |
| Address |
Department of acupuncture,
SDMCNYS,Belthangady, Dakshina Kannada, Ujire, Karnataka 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9655976897 |
| Fax |
|
| Email |
abitone.avr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Abitone V R |
| Designation |
Assistant professor |
| Affiliation |
SDM College of Naturopathy And Yogic Sciences |
| Address |
Department of acupuncture,
SDMCNYS,Belthangady, Dakshina Kannada, Ujire, Karnataka 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9655976897 |
| Fax |
|
| Email |
abitone.avr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shanthivana nature cure hospital |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Abitone V R |
Shanthivana nature cure hospital,dharmasthala |
Department of acupuncture,
SDMCNYS,Belthangady, Dakshina Kannada, Ujire, Karnataka 574240
Dakshina Kannada
KARNATAKA |
09655976897
abitone.avr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sdmcnys |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Electroacupuncture |
The patient is made to sit comfortably on a chair or stool. This group has been treated with the application of acupuncture needles with the help of electric current aka Electroacupuncture. Needles were kept for 20 minutes. Electrical stimulation was applied connected to the points ST35, EX-LE4, EX-LE2, SP10, ST36, GB34, SP9, and BL40. The intensity of stimulation was increased according to the comfort of the patient. This procedure lasts for 25 minutes. |
| Intervention |
Meridian balance method acupuncture |
Detailed questions are asked of the patient about the location, type, aggravating factor, and severity of pain. The patient is made to sit comfortably on a chair or stool. After assessing the exact location of the pain, the Sick meridian is identified as either ST or SP meridian or both ST and SP. Step 2 consists of choosing the balancing meridian according to the pain in the area, for example, if the pain is in ST meridian, it can be balanced by LI, SP or P meridians, and if the pain is in SP meridian, it is balanced by either LU, SI, ST or TW meridian. After choosing the treating meridian the points are selected according to the Mirror Imaging or Reverse mirror Imaging replicating knee image on the elbow joint. Tender points are selected and needled (mainly LI11, LI10, LI12, OR LU5, and nearby tender points). With the combination of Tung’s acupuncture using Mu Huo (11.10), ZongJian (11.05), SiHuaZhong (77.09), SiHuaXia (77.011) on the opposite hand, and SanJin (DT.07). The needles left retained for 20 minutes and this procedure lasts for about 25 minutes. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 25-70, Both males and females will be included, Preoperative visual analogue scale (VAS) score ≥4, Decreased range of motion, Persistent pain more than 6 months,Independently mobile (with or without aids)
|
|
| ExclusionCriteria |
| Details |
Developmental Knee deformities, Patients with a history of any psychiatric diseases, Suspected or confirmed pregnancy, Rheumatological or neurological diseases, Recent spinal fractures or back surgery, Presence of infection, tumors, or radicular symptoms, Unstable cardiac conditions, Body mass index of more than 30,Pain is secondary or not continues
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS), McGill Pain Questionnaire, Goniometer, Pain disability index, WOMAC scale |
2 time points(baseline and after 20 minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Insomnia Severity Index |
2 time points(baseline and after 20 minutes) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 clinical trial aimed to compare the immediate effects of Electroacupuncture and balance meridian acupuncture on chronic knee pain patients. The study had a sample size of 80 participants, with 40 individuals in each group. The duration of the treatment was 20 minutes. Assessment tools used in the study included the Visual Analogue Scale (VAS), McGill Pain Questionnaire, Goniometer, WOMAC scale, Pain Disability Index, and Insomnia
Severity Index. Data was collected at two-time points - baseline and after 20 minutes of treatment. This study aimed to evaluate the immediate impact of balance meridian acupuncture on pain management and explore the underlying mechanism of the intervention.
|