| CTRI Number |
CTRI/2024/02/063256 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of acupuncture needling for chronic neck pain individuals |
|
Scientific Title of Study
|
Effect of acupuncture needling at EX-UE-8 and cervical area(Auricular) for chronic neck pain individuals- 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 HarihniG |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG block, Arumbakkam, Chennai- 600 106
Chennai
TAMIL NADU
600106
India |
| Phone |
8248706942 |
| Fax |
|
| Email |
drharihni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrA Mooventhan |
| Designation |
Assistant Medical Officer cum lecturer grade 2 |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Research, second floor, Government Yoga and Naturopathy Medical College and Hospital, PG block, Arumbakkam,Chennai -106
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHarihni |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG block, Arumbakkam, Chennai- 600 106
Chennai
TAMIL NADU
600106
India |
| Phone |
8248706942 |
| Fax |
|
| Email |
drharihni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai- 600106 |
| 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 |
| DrHarihni G |
Government Yoga and Naturopathy Medical College and Hospital |
Department of Acupuncture and Energy Medicine, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG block, Arumbakkam, Chennai 600106
Chennai
TAMIL NADU |
8248706942
drharihni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 7||Osteopathic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture |
Acupuncture needling at EX-UE-8 & Cervical area for 10 days for about 30 minutes |
| Comparator Agent |
Control group not receive any acupuncture treatment |
No acupuncture needling for control group |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having neck pain more than 3 months.
|
|
| ExclusionCriteria |
| Details |
1)Patients with histories of surgery, fractures, or severe injuries in the cervical region
2)Other systemic illness
3)Patients who are pregnant, lactating and menstruating.
4)Patients participating in other studies.
5)Trypanophobia.
6)Ulceration of skin at selected acupoints.
7)Disable to communicate or critically ill.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neck disability index |
Neck disability index will be assessed before the day of intervention and after 10 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion, Quality of life and Visual Analog Scale |
Range of motion, Quality of life and Visual Analog Scales are assessed before the intervention and after 10 days of intervention |
|
|
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 1 |
|
Date of First Enrollment (India)
|
08/03/2024 |
| 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="2"
Days="0" |
|
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
|
Acupuncture is recognized as a effective tool for pain management. This study aims at with patients having chronic neck pain which is about more than 3 months are recruited for this study. The study group will receive acupuncture for 10 days for about 30 minutes, while the control group will not receive any acupuncture intervention. This study aims and work on pain, disability, range of motion and quality of life. The neck pain disability index, VAS scale used to measure pain and disability respectively, goniometer for range of motion and SF 12 questionnaire for quality of life. |