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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06407687
Other study ID # REC/RCR & AHS/23/0183
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date September 2024

Study information

Verified date June 2024
Source Riphah International University
Contact : Imran Amjad, PHD*
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mechanical low back pain (LBP) generally results from an acute traumatic event, but it may also be caused by cumulative trauma. The severity of an acute traumatic event varies widely, from twisting one's back to being involved in a motor vehicle collision. Mechanical LBP due to cumulative trauma tends to occur more commonly in the workplace and Quadratus Lumborum injury plays an important role in causing MLBP. The aim of this study is To compare the effects of Electrical Dry Needling and Dry Needling on pain, endurance and range of motion in patients with Quadratus Lumborum Syndrome.


Description:

A Randomized Clinical Trial will be conducted at Ali Afzal Shah Dispensary and Inam ul Haq Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using simple random sampling and patients will be divided in Group A and B. 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 1 session per week along with 5 day conventional physiotherapy a week for 4 weeks. Group 2 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 once per week and 5 days of conventional Physiotherapy per week for 4 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 26
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Electro Dry Needlig
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.
dry needling
Dry needling is a technique that acupuncturists, physical therapists and other trained healthcare providers use to treat musculoskeletal pain and movement issues.

Locations

Country Name City State
Pakistan Ali Afzal Shah Dispensary Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

Bryner P, HSR GD. Unilaterol bock poin: ci cose series of quodroitus lumborum. 1996.

de Franca GG, Levine LJ. The quadratus lumborum and low back pain. J Manipulative Physiol Ther. 1991 Feb;14(2):142-9. — View Citation

Fernández-de-las-Peñas C, Dommerholt JJTpdnae, approach c-b. Basic concepts of myofascial trigger points (TrPs). 2013:3-19.

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. — View Citation

MHMD H, Choudhury M, Mojumder M. A COMPARATIVE STUDY OF TREATMENT OF CHRONIC BACKACHE BETWEEN CONVENTIONAL METHOD AND TRIGGER POINT INJECTIONS (TPI).

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.

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. — View Citation

Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary NPRS 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
Primary Leg length Discrepancy 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
Primary Endurance 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
Primary Range of motion 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
Primary Disability 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
See also
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Completed NCT04719689 - Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis N/A