- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02012205
Wet Cupping in Non-specific Low Back Pain
Safety and Efficacy of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Controlled, Open-label, Parallel-group
Background: Persistent nonspecific low back pain (PNSLBP) is one of the most common low back pains worldwide. Many interventions were tried including wet cupping which is commonly used for pain conditions in Saudi Arabia and other parts in the world but without solid scientific evidence.
Aims: This study aims at determining safety and efficacy of wet cupping for treating PNSLBP.
Methods: This is a randomized wait-listed controlled clinical trial. Eligible patients with history of at least 3 months of PNSLBP will be randomized in to two groups, 45 patients each. The first group will be given wet-cupping treatment at two acupuncture points of urinary Bladder (BL) meridians among the BL23, BL24 and BL25, 6 times within 2 weeks. The second group will serve as a control group. Usual care, including providing brochures for exercise, general advice for PNSLBP and acetaminophen, will be allowed in both groups. Separate assessors participated in the outcome assessment. Investigators will use the 0 to100 numerical rating scale (NRS) for pain, the McGill Pain questionnaire for pain intensity (PPI) and the Oswestry Disability Questionnaire (ODQ), and to assess acetaminophen use and safety issues.
Expected Results: To provide data on the safety and effectiveness of wet cupping in treating PNSLBP and open the way for integrative medicine in Saudi Arabia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives:
To evaluate the effectiveness of wet cupping in the treatment of NSLBP:
- Primary objective: To assess the effect of wet cupping on Pain (difference in the NRS from base to the end of two weeks) compared to the control group
- Secondary objectives :
I-To compare Functioning (Oswestry Disability Questionnaire) from the base to the end of the two weeks of wet cupping sessions& two weeks later in the two groups II-To compare NRS from base to two weeks after the end of cupping III-To compare Number of Acetaminophen tables taken at the end of two weeks. IV-To evaluate Safety of wet cupping
SPECIFIC HYPOTHESIS: The hypothesis of this study is that the improvement of Numeric Rating Scale (NRS) for Pain at the end of the study will be greater in the Wet Cupping Treatment group than in the Control group
Overall Design: a randomised, waiting-list controlled, open-label, parallel trial.
- Study Type: Interventional
- Condition: Persistent Non Specific Low Back Pain (PNSLBP)
Case definition parameters:
- Low back pain: is defined as pain and discomfort, localized , below the costal margin and above the inferior gluteal folds, with or without referred leg pain.,
- Persistent low back pain: is defined as low back pain persisting for at least 12 weeks. We do not deal specifically with repeated, short bouts of pain.
- Nonspecific low back pain: is defined as" low back pain that is not attributable to a recognizable, known specific pathology (e.g. infection, tumour, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis), radicular syndrome or caudal equine syndrome)."
Study Design:
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Jeddah, Saudi Arabia
- King Fahad Specialist Hospital
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Madinah, Saudi Arabia
- King Fahad Hospital
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Riyadh, Saudi Arabia
- Prince Salman Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- - Patients who have had non-specific low back pains at least 12 weeks now.
- - Interested in using wet cupping therapy
- - Age equal or more than 18 years up to 60 years of age.
Exclusion Criteria:
1-Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
2-Patients who are inappropriate to the wet cupping treatment.
- ◦AIDS, Active Hepatitis, Tuberculosis, Syphilis. (N.B.)Referring physicians will be advised to exclude patients with the above mentioned diseases.
- ◦Patients who regularly take anticoagulants, antiplatelet drugs
- ◦Anemia, thrombocytopenia
- ◦Hemorrhagic disease like hemophilia
- ◦Diabetes
- ◦Severe cardiovascular disease
◦Kidney diseases (renal failure, chronic renal disease)
3-Patients who have experiences of wet cupping treatment during last 3 months. 4-Patients who have had treatment for low back pain during last 2 weeks. 5-Patients who are in pregnancy or have plan to conception. 6-Patients who have vertebra surgery or have plan of surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: wet cupping
patient will receive wet cupping
|
Participants assigned to the treatment group will receive wet-cupping therapy 3 times per week for 2 weeks
Other Names:
|
No Intervention: control
not cupping
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NRS
Time Frame: at the end of the two weeks wet cupping sessions.
|
Difference in Numeric Rating Score at the base and at the end of two weeks of cupping sessions.
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at the end of the two weeks wet cupping sessions.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scores of the McGill Pain questionnaire for pain intensity (PPI)
Time Frame: at the end of two weeks of cupping sessions and two weeks later
|
Change in the score from base line
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at the end of two weeks of cupping sessions and two weeks later
|
the Oswestry Disability Questionnaire (ODQ),
Time Frame: at the end of two weeks of cupping sessions and two weeks later
|
change in the score from the base line
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at the end of two weeks of cupping sessions and two weeks later
|
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: at the last visit, one week after the end of the last sessions
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Differences in number of participants with Serious and Non-Serious Adverse Events.
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at the last visit, one week after the end of the last sessions
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Collaborators and Investigators
Investigators
- Principal Investigator: Abdullah M AlBedah, MD, National Center for Complementary and Integrative Health (NCCIH)
- Study Director: Mohamed K.M. Khalil, MD, National Center for Complementary and Integrative Health (NCCIH)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOH044
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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