Persistent Non Specific Low Back Pain Clinical Trial
Official title:
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
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:
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment