| CTRI Number |
CTRI/2025/01/079774 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
a study to find how dry needling and intramuscular dry needling over quadratus lumborum muscle will be effective in mechanical low back pain |
|
Scientific Title of Study
|
Efficacy of dry needling and intramuscular electrical stimulation of Quadratus lumborum on pain, pain threshold postural sway, and disability among mechanical low back pain. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gerald Edwin Raj |
| Designation |
Professor |
| Affiliation |
Rvs college of Physiotherapy |
| Address |
RVS college of physiotherapy
out patient Department
sulur
Coimbatore
TAMIL NADU
641402
India |
| Phone |
9865397687 |
| Fax |
|
| Email |
jery1809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gerald Edwin Raj |
| Designation |
Professor |
| Affiliation |
Rvs college of Physiotherapy |
| Address |
RVS college of physiotherapy
242 B
Trichy road ,sulur
coimbatore
TAMIL NADU
641402
India |
| Phone |
9865397687 |
| Fax |
|
| Email |
jery1809@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vinodhkumar |
| Designation |
PROFESSOR |
| Affiliation |
SAVEETHA UNIVERSITY |
| Address |
Saveetha university
Thandalam
Kancheepuram dist
chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8760563032 |
| Fax |
|
| Email |
vinodhkumar.scpt@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha institute of medical and technical sciences
saveetha college of Physiotherapy
thandalam
kancheepuram dist
602105 |
|
|
Primary Sponsor
|
| Name |
saveetha university |
| Address |
Saveetha nagar
Thandalam
kanchipuram
chennai
chennai 602105 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gerald Edwin Raj |
RVS college of Physiotherapy OPD |
242-B
Trichy road
sulur
coimbatore
Coimbatore
TAMIL NADU |
9865397687
jery1809@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RVS COLLEGE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dry needling |
dry needling is a minimally invasive trigger point deactivation technique a thin solid sterilized 0.25mm thick needle is inserted intramuscularly in to myofascial trigger point and will be removed after 2-3 min this is performed for 2 times a week for 3 weeks |
| Intervention |
Intramuscular electrical stimulation |
Intramuscular electrical stimulation is new intervention technique used to deactivate myofascial trigger points low frequency current is applied intramuscularly over the myofascial trigger points for 2 to 3 min twice a week for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
presence of myofascial trigger points in Quadratus Lumborum muscle due to mechanical Low back pain |
|
| ExclusionCriteria |
| Details |
History of recent Fracture around Pelvic region
Diabetic neuropathies
Hemiplegia /Hemiparesis
Hemophilia
Needle phobia/Needle allergy
Immune system disorders and etc. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain
pain threshold
Disability
Postural sway
|
the outcome is measuredfirst at 0 week and after 3 weeks of treatment duration
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
pain threshold
postural sway
Disability
Postural sway
|
pain intervention assessed on day 1 & post intervention at end of each week for 2 weeks
carried out consecutive week follow up assessment was performed after 2 months post intervention period
|
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
10/02/2025 |
| 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="2"
Months="0"
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
|
Effectiveness of trigger point dry needling and percutaneous electrical nerve stimulation on Quadratus lumborum among mechanical low back pain patients we have done a pilot study with 45 patients in phase one and submitted results to saveetha university and now we are in the second phase of the study and this study will give various treatment optrions for patients suffering from mechanical low back pain
Research team S.Gerald edwin Raj , Professor RVS college of Physiotherapy . Coimbatore Research Guide DR. Vinodhkumar .Professor ,Saveetha UNiversity , Chennai . |