Wet Cupping in Non-specific Low Back Pain
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Controlled, Open-label, Parallel-group|
- NRS [ Time Frame: at the end of the two weeks wet cupping sessions. ] [ Designated as safety issue: No ]Difference in Numeric Rating Score at the base and at the end of two weeks of cupping sessions.
- 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 ] [ Designated as safety issue: No ]Change in the score from base line
- the Oswestry Disability Questionnaire (ODQ), [ Time Frame: at the end of two weeks of cupping sessions and two weeks later ] [ Designated as safety issue: No ]change in the score from the base line
- 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 ] [ Designated as safety issue: Yes ]Differences in number of participants with Serious and Non-Serious Adverse Events.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: wet cupping
patient will receive wet cupping
Procedure: wet cupping
Participants assigned to the treatment group will receive wet-cupping therapy 3 times per week for 2 weeks
Other Name: Hijamah
No Intervention: control
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)."
Please refer to this study by its ClinicalTrials.gov identifier: NCT02012205
|Contact: Mohamed KM Khalil||00966504955087||STATKHL@HOTMAIL.COM|
|King Fahad Specialist Hospital||Recruiting|
|Jeddah, Saudi Arabia|
|Principal Investigator: Faiasl Bazaid, MD|
|King Fahad Hospital||Recruiting|
|Madinah, Saudi Arabia|
|Principal Investigator: Raid Abtalib, MD|
|Prince Salman Hospital||Recruiting|
|Riyadh, Saudi Arabia|
|Principal Investigator: AbuBakr Essa, MD|
|Principal Investigator:||Abdullah M AlBedah, MD||National Center for Complementary and Alternative Medicine (NCCAM)|
|Study Director:||Mohamed K.M. Khalil, MD||National Center for Complementary and Alternative Medicine (NCCAM)|