- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06140264
Effect of Acupuncture Dry Needle in Treatment of Chronic Mechanical Low Back Pain
Short Term Effect of Acupuncture Dry Needle in Treatment of Chronic Mechanical Low Back Pain: A Randomized Controlled Clinical Trial
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Riyadh
-
Al-Kharj, Riyadh, Saudi Arabia, 11942
- Walid Kamal Abdelbasset
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ranges from 20 to 45 years old.
- Pain of at least 30 mm to 70 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 100 mm (worst imaginable pain).
- Presence of MTrPs at least in 4 muscles on any side.
- Patients had lower back myofascial pain syndrome for at least 3 months ago.
Exclusion Criteria:
A history of previous back surgery, neurologic deficit, current lower extremity symptoms, cardiopulmonary disease with decreased activity tolerance, rheumatologic conditions, polyarticular osteoarthritis, rheumatoid arthritis and advanced lumbar degenerative disease, patients receiving other treatment in the form of physical therapy or medication for the duration of the study that may interfere with the results of this study.
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 |
|---|---|
|
Active Comparator: Acupuncture dry needle
This group received acupuncture dry needle over trigger points of back muscles followed by stretching and strengthening exercises for back muscles, 2 sessions per week for 2 weeks.
|
The muscles that have been treated iliocostalis lumborum, quadratus lumborum, gluteus medius and piriformis muscles.
The patients received 2 sessions per week for 2 weeks.
|
|
No Intervention: Stretching and strengthening exercises
This group received only stretching and strengthening exercises for back muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Four weeks
|
Pain was assessed by Visual Analog Scale (VAS).
VAS is a scale that allows continuous data analysis and uses a 10 cm line with 0 in one end (no pain) and 10 (worst pain) on the other end.
Patients were asked to place a mark along the line to denote their level of pain.
|
Four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional disability
Time Frame: Four weeks
|
Functional disability of each patient was assessed by Oswestery disability questionnaire.
It is valid and reliable tool.
It is consists of 10 multiple choice questions for back pain, patient select one sentence out of six that best describe his pain, Higher scores indicated great pain.
Scores (0-20%) minimal disability, Scores (20%- 40%) moderate, Scores (40% - 60%) severe, Scores (60%-80%) crippled, Scores (80% - 100%) patients are confined to bed.
|
Four weeks
|
|
Lumbar range of motion
Time Frame: Four weeks
|
Modified-modified Schober flexion technique was used based on the work of Williams et al.
This method is reliable and valid in measuring range of motion of lumbar flexion.
The investigator stood behind the standing patient to identify the posterior superior iliac spines with her or his thumbs, and then an ink mark was drawn along the midline of the lumbar spine horizontal to the posterior superior iliac spines.
Another ink mark was made 15 cm above the original mark; the distance between superior and inferior skin marks was measured.
Then the investigator instructed the patient to bend forward into full lumbar flexion and the new distance between superior and inferior skin marks was measured.
|
Four weeks
|
Collaborators and Investigators
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
- RHPT/022/035
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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