| CTRI Number |
CTRI/2025/08/092438 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the dry needling on the hamstring and quadratus lumborum muscles to reduce pain and improve movement in people with chronic low back pain |
|
Scientific Title of Study
|
Effectiveness of Dry Needling for Hamstring and Quadratus Lumborum in Managing Pain and Disability in Chronic Low Back Pain: A Comparative Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tannu |
| Designation |
MPT (Orthopedics) |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Chheharta Rd, Makka Singh Colony Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
08368618697 |
| Fax |
|
| Email |
tannurana060@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharnpreet KaurPT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Chheharta Rd, Makka Singh Colony Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
09877781036 |
| Fax |
|
| Email |
shrnpreet.pht@gndu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharnpreet KaurPT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Chheharta Rd, Makka Singh Colony Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
09877781036 |
| Fax |
|
| Email |
shrnpreet.pht@gndu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Guru Nanak Dev University, G.T. Road, Amritsar - 143005, Punjab, India |
|
|
Primary Sponsor
|
| Name |
Tannu |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, G.T. Road, Amritsar - 143005, Punjab, India |
| 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 Tannu |
Health Centre |
Room: Physiotherapy Room, Health Centre, Guru Nanak Dev University, Amritsar
Amritsar
PUNJAB |
08368618697
tannurana060@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Guru Nanak Dev University, Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
The patients will perform the Stretching of lumbar extensors, Stretching of hip flexors, abdominal muscle strengthening, trunk mobility and pelvic tilts. The data will be collected at baseline(before the intervention) and after 6 weeks of treatments the post data will be collected. |
| Intervention |
Dry Needling on Quadratus Lumborum and Hamstring muscle |
Position of the patient: Prone Lying, the physiotherapist will thoroughly cleaning the treatment area with an antiseptic. The specific location for dry needling was marked. The stainless-steel needle was directed on myofascial trigger points of quadratus lumborum and hamstring muscle. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
The study will include the patients of specific and non specific chronic back pain which persist more than 3 months. The subjects will not be taken any physiotherapy treatment from last 4 months. |
|
| ExclusionCriteria |
| Details |
The subjects will be excluded who having Red flags indicative of serious spinal pathology with signs and symptoms of nerve root compromise.
Any obvious spinal deformity or neurological diseases. A reported history of cardiovascular diseases contraindicated to exercise; or individuals who were with elevated blood pressure. Chronic low back pain due to rheumatoid arthritis, ankylosing spondylitis, Lumbar scoliosis, radiculopathies, tumors, or chronic rheumatological diseases, including axial spondyloarthritis (axSpA). Fibromyalgia, corticosteroids or other oral medications treatment and history of spinal surgery. Contraindications for dry needle (needle phobia, coagulation or psychological disorders, varicose regions, cysts, wound, metal or latex allergy, lymphedema, hypothyroidism, diabetes. Those participants with hamstring tightness and pregnancy. Subjects who do not meet the age group.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain, Hamstring Flexibility,
Lumbar Flexibility, Disability,
and Quality of life. |
At baseline and after 6 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
17/08/2025 |
| 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="0"
Months="1"
Days="15" |
|
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
|
Low back pain is a widespread
condition that affects many people at some point in their lives. Chronic Low Back Pain is a recognized public health
issue that tends to worsen over time, often leading to the formation of trigger
points in the quadratus lumborum (QL) muscle and hamstring tightness, which is commonly associated with
chronic low back pain. The available literature stated
that needling to hamstring and quadratus lumborum helps to ease the chronic low
back pain but till now none of the study compare their effects like which one
is better one. The present study analyses the effect of dry needling on
hamstring and quadratus lumborum to assess which approach is better one to improving pain, functionality, mobility, quality of life in
patients with chronic low back pain. |