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
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | January 2015 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: 1. - Patients who have had non-specific low back pains at least 12 weeks now. 2. - Interested in using wet cupping therapy 3. - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Saudi Arabia | King Fahad Specialist Hospital | Jeddah | |
| Saudi Arabia | King Fahad Hospital | Madinah | |
| Saudi Arabia | Prince Salman Hospital | Riyadh |
| Lead Sponsor | Collaborator |
|---|---|
| National Center for Complementary and Alternative Medicine, Saudi Arabia |
Saudi Arabia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | NRS | Difference in Numeric Rating Score at the base and at the end of two weeks of cupping sessions. | at the end of the two weeks wet cupping sessions. | No |
| Secondary | Scores of the McGill Pain questionnaire for pain intensity (PPI) | Change in the score from base line | at the end of two weeks of cupping sessions and two weeks later | No |
| Secondary | the Oswestry Disability Questionnaire (ODQ), | change in the score from the base line | at the end of two weeks of cupping sessions and two weeks later | No |
| Secondary | Number of Participants with Serious and Non-Serious Adverse Events | Differences in number of participants with Serious and Non-Serious Adverse Events. | at the last visit, one week after the end of the last sessions | Yes |