| CTRI Number |
CTRI/2022/08/045032 [Registered on: 29/08/2022] Trial Registered Prospectively |
| Last Modified On: |
06/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare which treatment is better for the management of myofascial pain syndrome - dry needling or ozone therapy. |
|
Scientific Title of Study
|
A randomized control study to compare the efficacy of ozone therapy and dry needling in the management of myofascial pain syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renu Anna Johnson |
| Designation |
PG student |
| Affiliation |
AIIMS PATNA |
| Address |
Department of PMR, All India Institute of Medical Sciences, Patna, Phulwari Sharif , Bihar.
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
renuannajohnson@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Pandey |
| Designation |
Additional Professor and Head of Department, PMR department |
| Affiliation |
AIIMS PATNA |
| Address |
Department of PMR, All India Institute of Medical Sciences, Patna, Phulwari Sharif , Bihar.
Department of PMR, AIIMS PATNA, PHULWARI SHARIF, PATNA, BIHAR - 801507
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drsanjaykr1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renu Anna Johnson |
| Designation |
PG student |
| Affiliation |
AIIMS PATNA |
| Address |
Department of PMR, All India Institute of Medical Sciences, Patna, Phulwari Sharif , Bihar.
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
renuannajohnson@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS PATNA,
Phulwari Sharif, Patna, Bihar- 801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
AIIMS PATNA, Phulwari Sharif, Patna, Bihar, 801507 |
| 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 Renu Anna Johnson |
AIIMS PATNA |
Department of PMR,PMR building, AIIMS PATNA, Phulwari Sharif, Patna Bihar, 801507
Patna
BIHAR |
9446540250
renuannajohnson@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- AIIMS, Patna |
Approved |
|
|
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 |
Dry needling |
Dry needling will be done once at the beginning of the study without any injectate or drug with a monofilament needle using fast in and fast out method into the myofascial trigger point. |
| Comparator Agent |
Ozone therapy |
Ozone therapy will be given once with the help of a medical ozone generator, 8 cc of ozone gas at a concentration of 15 microgram per ml using a needle in the beginning of the study in the myofascial trigger point. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with myofascial pain syndrome attending AIIMS PATNA OPD and consenting patients |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain using Visual analogue scale VAS |
Follow up will be done at baseline, 2 weeks and 4 weeks using VAS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Depression, anxiety and stress using DASS 21 scale |
Followup will be done at baseline,2 weeks and 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/09/2022 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomised control study comparing the efficacy of ozone therapy and dry needling in the management of myofascial pain syndrome. Patients would be included from those attending AIIMS PATNA OPD. |