- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407687
Compare Electrodry Needlig and Dry Needling in Mechanical Low Back Pain
Comparative Effects of Electro Dry Needling Versus Dry Needling on Pain, Endurance and Range of Motion in Patients With of Quadratus Lumborum Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 05499
- Ali Afzal Shah Dispensary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 25 to 45 years.
- Male and females both included.
- Muscle hypersensitivity on palpation
- Deep aching pain in sides of the lower back.
- Positive side-bridge test (Right < 83.2 sec and Left < 81.5 sec)
- Positive Simon's criteria for Quadratus Lumborum
- Patients with NPRS <7
- ODI score of < 40
- Decreased Lumber Side flexion and extension ROM
- Positive apperent Leg Length Discrepancy with more than 2 cm
- Negative Laslet's criteria for sacroiliac dysfunction
Exclusion Criteria:
- People with real leg length discrepancy
- People with any other medical condition Including Lumbar fracture, Spondylolisthesis, Ankylosing Spondylysis, Rheumatoid Arthritis. All these conditions will be ruled out with carefully history and examination.
- People taking any other form of treatment including corticosteroids, non-steroidal anti-inflammatory drugs or analgesics.
- People with previous history of surgical treatment for Lumbar spine. o People with neurological deficits or systemic illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Electric dry needling
Group A will receive Electrical Dry Needling along with conventional physiotherapy.
The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes Frequency 80-100 Hz, Duration 10-30 minutes and intensity as tolerated.
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Electro Dry Needling is a modified form of dry needling which utilises an electro-stimulation unit connected via cables to fine filament needles.
The combination of dry needling with electro-stimulation often prolongs the pain relief effect by blocking nerve pathways and preventing pain signals from travelling to the brain.
|
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Active Comparator: Dry needling
Group B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes.
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Dry needling is a technique that acupuncturists, physical therapists and other trained healthcare providers use to treat musculoskeletal pain and movement issues.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS
Time Frame: 4th week
|
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). |
4th week
|
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Leg length Discrepancy
Time Frame: 4th week
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Involves measuring limb length with a tape measure between 2 defined points, in the stand.
Two common points are the anterior iliac spine and the medial malleolus or the anterior inferior iliac spine and lateral malleolus
|
4th week
|
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Endurance
Time Frame: 4th week
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The McGill Torso Endurance Tests are a useful battery of tests that assess all sides of the trunk allowing us to assess the endurance capacity of the torso muscles or if there is an imbalance between these three muscle groups which can contribute to low-back dysfunction and core instability.
|
4th week
|
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Range of motion
Time Frame: 4th week
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Universal goniometer will be used to measure side binding ROM of Lumber Spine in atient with Quadratus Lumborum Syndrome.Universal goniometer is tool that has two arms and a fulcrum in which one arm remains fixed and the other arm moves to measure the ROM.
The norm side bending ROM of Lumber Spine is 20 degress on each side.
Its reliability is 0.97 and validity is 0.98
|
4th week
|
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Disability
Time Frame: 4th week
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ODI scoring is used to measure the disability of the patient.
ODI score system consists of sections which includes a score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
And in this study the patients with moderate disability will be included for the study and its Reliability is 0.88 and validity is 0.93
|
4th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabiya Noor, PhD, Riphah International University
Publications and helpful links
General Publications
- Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
- Wong AYL, Karppinen J, Samartzis D. Low back pain in older adults: risk factors, management options and future directions. Scoliosis Spinal Disord. 2017 Apr 18;12:14. doi: 10.1186/s13013-017-0121-3. eCollection 2017.
- Trompeter K, Fett D, Platen P. Prevalence of Back Pain in Sports: A Systematic Review of the Literature. Sports Med. 2017 Jun;47(6):1183-1207. doi: 10.1007/s40279-016-0645-3.
- Pandey E, Kumar N, Das SJPOTJ. Effect of stretching on shortened quadratus lumborum muscle in non specific low back pain. 2018;11(2):80-6.
- MHMD H, Choudhury M, Mojumder M. A COMPARATIVE STUDY OF TREATMENT OF CHRONIC BACKACHE BETWEEN CONVENTIONAL METHOD AND TRIGGER POINT INJECTIONS (TPI).
- Bryner P, HSR GD. Unilaterol bock poin: ci cose series of quodroitus lumborum. 1996.
- Grover C, Christoffersen K, Clark L, Close R, Layhe S. Atraumatic Back Pain Due to Quadratus Lumborum Spasm Treated by Physical Therapy with Manual Trigger Point Therapy in the Emergency Department. Clin Pract Cases Emerg Med. 2019 May 29;3(3):259-261. doi: 10.5811/cpcem.2019.4.42788. eCollection 2019 Aug.
- Fernández-de-las-Peñas C, Dommerholt JJTpdnae, approach c-b. Basic concepts of myofascial trigger points (TrPs). 2013:3-19.
- de Franca GG, Levine LJ. The quadratus lumborum and low back pain. J Manipulative Physiol Ther. 1991 Feb;14(2):142-9.
- Borenstein D. Mechanical low back pain--a rheumatologist's view. Nat Rev Rheumatol. 2013 Nov;9(11):643-53. doi: 10.1038/nrrheum.2013.133. Epub 2013 Sep 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0183
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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