| CTRI Number |
CTRI/2025/02/080574 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
How Electro-Acupuncture impacts nerve function and pain relief in Acute Low Back Pain based on treatment duration: A Two-Arm Clinical Study |
|
Scientific Title of Study
|
Evaluation of Electro-acupuncture - induced Autonomic function in relation to treatment duration among patients with Acute Non-specific Low Back Pain - A Two Arm 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 |
Dr Jebalin Josco J |
| Designation |
PG Scholar |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences, Chengalpattu |
| Address |
Yoga and Naturopathy(Branch-3) Department of Acupuncture and Energy Medicine International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar nagar Chengalpattu Ammanambaakam Tamil Nadu 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9092268116 |
| Fax |
|
| Email |
drjebalinjohn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geethanjali Shankar |
| Designation |
Head of Department |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences Chengalpattu |
| Address |
Department of Acupuncture and Energy Medicine International Institute of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam Tamil Nadu 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat.007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jebalin Josco J |
| Designation |
PG Scholar |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences Chengalpattu |
| Address |
Yoga and Naturopathy(Branch-3) Department of Acupuncture and Energy Medicine International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar nagar Chengalpattu Ammanambaakam Tamil Nadu 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9092268116 |
| Fax |
|
| Email |
drjebalinjohn@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam Tamil Nadu India 603001 |
|
|
Primary Sponsor
|
| Name |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
International Institute of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam Tamil Nadu 603001 |
| Type of Sponsor |
Government medical college |
|
|
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 Jebalin Josco J |
International Institute Of Yoga And Naturopathy Medical Sciences |
Naturopathy and yoga Branch3 Department of Acupuncture and Energy Medicine 184/4 Kamarajar Nagar Chengalpattu Ammanambaakam Tamil Nadu 603001
Kancheepuram
TAMIL NADU |
9092268116
drjebalinjohn@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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electro-Acupuncture |
Arm 1: Acupuncture needling at UB-25, UB-26, GV-4, with electrical stimulation over UB-25, UB-26 acupuncture points bilaterally for 20 mins. |
| Comparator Agent |
Electro-Acupuncture |
Arm 2: Acupuncture needling at UB-25, UB-26, GV-4, with electrical stimulation over UB-25, UB-26 acupuncture points bilaterally for 40 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The study includes individuals aged 18 years and older who have non-radicular low back pain, restricted to the area above the knee or experiencing somatically referred pain only. Participants must not have received any acupuncture or related therapy in the 7 days prior to study entry. Informed consent must be signed, and participants should score more than 3 on the Visual Analog Scale (VAS) during screening to be eligible for the study. |
|
| ExclusionCriteria |
| Details |
The study excludes individuals under the age of eighteen and those with low back pain caused by factors such as tumors, infections, metabolic conditions, inflammatory arthritis, or fractures. Participants with recognized abnormalities, including scoliosis, spondylolisthesis, or spondylolysis, as well as those experiencing pain below the knee or associated with conditions unrelated to the spine (e.g., visceral, vascular, or genito-urinary causes) are also excluded. Individuals who have previously undergone lumbar surgery, have nervous system impairments, or experience back pain linked to multiple areas of extensive multi-site discomfort are not eligible. Additionally, pregnant or lactating women, those who have used any form of acupuncture in the 7 days prior to study entry, individuals with implanted medical devices such as pacemakers, and patients with a known allergy to acupuncture needles or electroacupuncture materials are also excluded from the study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HRV |
20 minutes and 40 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Algometry |
20 minutes and 40 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [drjebalinjohn@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
Electro-acupuncture works by stimulating specific acupuncture points, activating sympathetic nerve fibers, and increasing endogenous opioids, which help reduce pain and inflammation. Treatment durations of 20 and 40 minutes have been shown to effectively reduce pain. By targeting acupuncture points UB-25 and UB-26 with electro-acupuncture, along with GV-4 through normal acupuncture, this treatment aims to enhance autonomic nervous system function, alleviate pain, and promote healing. Increased parasympathetic activity is expected as part of the therapeutic effect, contributing to pain relief and improved healing. The study will compare the efficacy of these two time intervals in providing pain relief and improving autonomic function in patients with acute NSLBP. This study aims to explore the effects of electro-acupuncture on acute non-specific low back pain (NSLBP). A total of 60 participants will be randomly assigned to two groups, each consisting of 30 individuals. Arm 1 will receive electro-acupuncture with electrical stimulation at UB-25 and UB-26 for 20 minutes, along with normal acupuncture at GV-4, while Arm 2 will undergo the same treatment for 40 minutes. The primary measures for assessing baseline and outcomes will include heart rate variability (HRV) and Algometry, both of which will be recorded before and after treatment.
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