| CTRI Number |
CTRI/2024/05/066716 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Trigger Point Release Technique of Repetitive Needling with Local Anaesthetic agent versus Local Anaesthetic agent plus Steroid in patients with Myofascial Pain Syndrome. |
|
Scientific Title of Study
|
Comparison of Trigger Point Release Technique of Repetitive Needling with Lignocaine versus Lignocaine Plus Steroid in Management of Myofascial Trigger Points – 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 REVATHY S M |
| Designation |
PG JR |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of PMR, AIIMS RAIPUR, CHHATTISGARGH
492099
INDIA
Raipur
CHHATTISGARH
492099
India |
| Phone |
9446100629 |
| Fax |
|
| Email |
revathysm555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMOL KHADE |
| Designation |
Associate Professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of PMR, AIIMS RAIPUR, CHHATTISGARGH
492099
INDIA
Raipur
CHHATTISGARH
492099
India |
| Phone |
9373404138 |
| Fax |
|
| Email |
pdlamolkhade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Revathy S M |
| Designation |
Post Graduate Resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of PMR, AIIMS Raipur, Chhattisgargh
492099
India
CHHATTISGARH
492099
India |
| Phone |
9446100629 |
| Fax |
|
| Email |
revathysm555@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal Investigator AIIMS Raipur |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Revathy S M |
AIIMS RAIPUR |
Department of PMR AIIMS Raipur Chhattisgargh India
Raipur
CHHATTISGARH |
9446100629
revathysm555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTEETHICSCOMMITTEEAIIMSRAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M791||Myalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing local anaesthetic group alone with local anaesthetic and corticosteroid group. |
Patients will be randomized into 2 groups. Group 1 will receive 5 ml Lignocaine with Adrenaline followed by repeated needling techniques to release trigger point. Group 2 will receive 5 ml Lignocaine with Adrenaline and 1ml 40mg/ml corticosteroid followed by repeated needling techniques to release trigger point. Both groups will be compared with VAS scale and WHOQOL BREF Questionnaire pre procedure, 2 weeks and 6 weeks post procedure. If there is no relief in pain, during the second follow up patient can be planned for repeat intervention. In case of persisting pain again patient will be managed accordingly but will not be considered further for the study. |
| Intervention |
Myofascial Trigger point injection |
Patients will be randomized into 2 groups. Group 1 will receive 5 ml Lignocaine with Adrenaline followed by repeated needling techniques to release trigger point. Group 2 will receive 5 ml Lignocaine with Adrenaline and 1ml 40mg/ml corticosteroid followed by repeated needling techniques to release trigger point. Both groups will be compared with VAS scale and WHOQOL BREF Questionnaire pre procedure, 2 weeks and 6 weeks post procedure. If there is no relief in pain, during the second follow up patient can be planned for repeat intervention. In case of persisting pain again patient will be managed accordingly but will not be considered further for the study. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Myofascial trigger points of any duration.
FaileConservative trial of management tried for at least1 week. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain scores measured by the visual analogue scale (VAS) in which 0 indicated no pain and 10 indicated the most intense pain imaginable. |
Baseline 2 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life Assessment using WHO Bref questieneir |
WHO Bref questioneir will be assessed before the procedure and 6 weeks after the procedure. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients satisfying the inclusion and exclusion criteria will be managed conservatively for 1 week as per standard care plan. After 1 week if pain is persisting will taken up for intervention. Patient will be divided into 2 groups by envelope method , group 1 will receive 5 ml 2% Lignocaine with adrenaline (1:200000) (ATD) and Group 2 will receive 4ml 2% Lignocaine with adrenaline (1:200000) (ATD) and 1 ml 40 mg/ml Triamcinolone Acetate with 24G needle followed by repeated needling techniques. Pre procedure VAS & WHOQOL BREF will be assessed. Patient will be reassessed in 2 weeks and 6 weeks with VAS & WHOQOL BREF. |