| CTRI Number |
CTRI/2023/11/059813 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Acupuncture for acute neck pain |
|
Scientific Title of Study
|
Effect of Selective Acupuncture points on pain and disability index in patients with acute neck pain - A 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 N B RAJENDRAN |
| 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 (first floor) , Department of Acupuncture and Energy Medicine,Kamarajar nagar,chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7845536679 |
| Fax |
|
| Email |
rajendranbhuvan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N PRABU |
| Designation |
Assistant Medical Officer/ Grade II Lecturer |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences,Faculty block (first floor) ,Kamarajar nagar, Department of Acupuncture and Energy Medicine,chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9566351891 |
| Fax |
|
| Email |
drprabubnys91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N B RAJENDRAN |
| 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 (first floor) , Department of Acupuncture and Energy Medicine,Kamarajar nagar,chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7845536679 |
| Fax |
|
| Email |
rajendranbhuvan@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences |
|
|
Primary Sponsor
|
| Name |
DR N B RAJENDRAN |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences,Faculty block (first floor) ,Kamarajar nagar,chengalpattu |
| 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 N B RAJENDRAN |
International Institute of Yoga and Naturopathy medical sciences |
184/4,International Institute of Yoga and Naturopathy Medical Sciences,Faculty block (first floor), Department of Acupuncture and Energy Medicine,Kamarajar nagar,chengalpattu
Kancheepuram
TAMIL NADU |
7845536679
rajendranbhuvan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture Needling for Acute neck pain |
Acupuncture needling at LU 7,LI 4,SI 3,GV 20 for 3 days in a week follow up for 3 weeks |
| Comparator Agent |
Sham Acupuncture |
Sham Acupuncture for 3 days in a week follow up for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a confirmed diagnosis of acute neck pain caused by stiff neck and willing to give consent |
|
| ExclusionCriteria |
| Details |
History of neck trauma cervical fracture spinal canal cancer acute neck pain with ulcers on the neck region pregnancy and lactating women
fear of acupuncture needles patients with mental or neurological diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of acute neck pain through visual analogue scale , neck pain and disability scale |
Pre and post assessment on each session for 3 days a week for the total of 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Heart Rate Variability |
Pre & post assessment on each session for 3 days a week for the total of 3 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
27/11/2023 |
| 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) |
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 - Any purpose.
- By what mechanism will data be made available?
Response (Others) - ONLINE
- For how long will this data be available start date provided 20-11-2023 and end date provided 21-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Acute neck pain according to the Neck Pain Task Force comes under grade II clinical classification of pain showing no signs or symptoms of major structural pathology but major interference with the activities of daily living .It usually lasts from 7 days to a month . Acute neck pain may become chronic in about 10% of people . Prevalence is highest in middle age , with women being affected more than men . Neck pain is the fourth leading cause of disability , with an annual prevalence rate exceeding 30% . Acupuncture is a therapeutic form of traditional Chinese medicine ( TCM) that involves the insertion of fine needle on the defined points and usually follows by stimulation using related manual or electrical techniques . Acupuncture appears to be a safe treatment modality for acute neck pain , as adverse effects are minor and were cost effective . According to the theory of Chinese traditional medicine , acupoints and tender points may become sensitized when the body is in a diseased state. Stimulation of such sensitive points may lead to disease improvement and improved clinical efficacy . This study aims to evaluate the efficacy and safety of needling at selective acupuncture points in providing pain relief , improvement of cervical vertebral function and quality of life in patients with Acute neck pain . The pre and post assessments will be done each session for 3 days a week with a follow up for 3 weeks . This randomized control study will be conducted among the 60 participants both male and female aged between 18- 65 years . All the eligible subjects will be randomly divided into 2 groups . The study group will undergo needling ( LU 7 , SI 3 , LI 4 , GV 20 ) for 3 days a week with a follow up for 3 weeks. While the control group will be given sham acupuncture for 3 days a week with a follow up for 3 weeks . Assessment will be measured by Visual Analog Scale ( VAS) and Neck Pain and Disability Scale ( NPAD) and assessment of autonomic changes in the body through heart rate variability before and after each session for 3 days a week with a follow up for 3 weeks. |