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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04719689
Other study ID # REC/Lhr/20/0101 Huma Akhtar
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date July 1, 2021

Study information

Verified date August 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project was a Randomized clinical trial conducted to Compare the effects of dry needling and dry cupping in Positional fault of pelvis due to Myofascial trigger points in Quadratus Lumborum so that we can have best treatment option for patients with myofascial trigger points.


Description:

Non Probability Convenient sampling was done. Patients following eligibility criteria from Physiotherapy department of Islam Central hospital, Sialkot were considered. Sample size was calculated with Epitool calculator. 26 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A was given Dry needling technique and Group B was given Dry Cupping along with conventional physiotherapy treatment (hot pack and stretching). Duration of research was almost 6 months. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus Lumborum. All participants were provided written informed consent prior to commencement of the procedures. They were free to quit the treatment at any stage of research. Data was analyzed by using SPSS version 23.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - On palpation the presence of at least 1 active trigger point in quadratus lumborum. So the patient presents with low back pain. - Patients presents with positional fault of pelvis (lateral tilt)(4). - Patients having chronic Low Back Pain for at least more than 6 months(3). - Patients agree to get treatment sessions for the research work. Exclusion Criteria: - Participants should not have taken any medications like analgesics, anti-coagulants, Non-steroidal anti-inflammatory drugs or muscle relaxants during this study or even 3 days before this study. - Participants should not have received any other treatment for the pain management, because it will affect the results of the study. - Patients with bleeding disorders, local or systemic infection, acute muscle trauma. - Patients with comorbid conditions. - Patients with severe physical disability and true leg length discrepancy(1). - Pregnant females

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dry needling
Experimental group 1 got this intervention containing Dry needling for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus lumborum
Dry cupping
Experimental group 2 got this intervention containing Dry cupping for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus Lumborum

Locations

Country Name City State
Pakistan Riphah IU Lahore

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Haake M, Müller HH, Schade-Brittinger C, Basler HD, Schäfer H, Maier C, Endres HG, Trampisch HJ, Molsberger A. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007 Sep 24;167(17):1892-8. Erratum in: Arch Intern Med. 2007 Oct 22;167(19):2072. — View Citation

Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296. Review. — View Citation

Leetun DT, Ireland ML, Willson JD, Ballantyne BT, Davis IM. Core stability measures as risk factors for lower extremity injury in athletes. Med Sci Sports Exerc. 2004 Jun;36(6):926-34. — View Citation

Pavkovich R. EFFECTIVENESS OF DRY NEEDLING, STRETCHING, AND STRENGTHENING TO REDUCE PAIN AND IMPROVE FUNCTION IN SUBJECTS WITH CHRONIC LATERAL HIP AND THIGH PAIN: A RETROSPECTIVE CASE SERIES. Int J Sports Phys Ther. 2015 Aug;10(4):540-51. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Pain by 'Pressure Pain Algometer' Change in Pain from baseline was checked at 6th session by Pressure Pain Algometer. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Baseline, 6th session(at 3rd week), follow up session after 1 month
Primary Change in Range of Motion of lumbar spine side flexion by 'Goniometer' Change in ROM from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. A goniometer is a device that measures an angle or permits rotation of an object to a definite position Baseline, 6th session(at 3rd week), follow up session after 1 month
Secondary Change in pain by 'Numeric Pain Rating Scale' Change in pain from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. The Numerical Pain Rating Scale (NPRS) is an 11 point pain scale that is completed by a patient himself, under the supervision of researcher. Baseline, 6th session(at 3rd week), follow up session after 1 month
Secondary Change in Range of Motion of lumbar side flexion by Measuring tape Change in ROM from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. The method for using a tape measure to examine lateral flexion of the spine has been introduced in the literature. Baseline, 6th session(at 3rd week), follow up session after 1 month
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