Wet Cupping in Non-specific Low Back Pain
Condition: Persistent Non Specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      Objectives:

      To evaluate the effectiveness of wet cupping in the treatment of NSLBP:

        1. 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

        2. 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:
    

Intervention name(s): wet cupping
Intervention type(s): Procedure
Intervention description(s): Participants assigned to the treatment group will receive wet-cupping therapy 3 times per week for 2 weeks
Other intervention name(s): Hijamah
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wet cupping - back pain - NSLBP - Saudi