- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04719689
Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis
August 27, 2021 updated by: Riphah International University
Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis Due to Myofascial Trigger Points in Quadratus Lumborum
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Lahore, Pakistan, 54000
- Riphah IU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Dry needling
Dry needling, hot pack, stretching exercises.
|
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
|
Experimental: Dry Cupping
Dry cupping, hot pack, stretching exercises.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain by 'Pressure Pain Algometer'
Time Frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
|
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
|
Change in Range of Motion of lumbar spine side flexion by 'Goniometer'
Time Frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain by 'Numeric Pain Rating Scale'
Time Frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
|
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
|
Change in Range of Motion of lumbar side flexion by Measuring tape
Time Frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer 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. doi: 10.1001/archinte.167.17.1892. Erratum In: Arch Intern Med. 2007 Oct 22;167(19):2072.
- 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. doi: 10.1249/01.mss.0000128145.75199.c3.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2019
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
January 10, 2021
First Submitted That Met QC Criteria
January 19, 2021
First Posted (Actual)
January 22, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 27, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/20/0101 Huma Akhtar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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