Wet Cupping in Non-specific Low Back Pain

NCT02012205 | Completed DMC

• 1 other identifier: MOH044
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Persistent Non Specific Low Back Pain

Keywords

wet cupping - back pain - NSLBP - Saudi

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Scores of the McGill Pain questionnaire for pain intensity (PPI)

  at the end of two weeks of cupping sessions and two weeks later

• the Oswestry Disability Questionnaire (ODQ),

  at the end of two weeks of cupping sessions and two weeks later

• Number of Participants with Serious and Non-Serious Adverse Events

  at the last visit, one week after the end of the last sessions

Study Arms (2)

wet cupping

EXPERIMENTAL

patient will receive wet cupping

Procedure: wet cupping

control

NO INTERVENTION

not cupping

Interventions

wet cupping PROCEDURE

Participants assigned to the treatment group will receive wet-cupping therapy 3 times per week for 2 weeks

Also known as: Hijamah

wet cupping

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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).
• 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)
• 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.

Sponsors & Collaborators

• National Center for Complementary and Alternative Medicine, Saudi Arabia: lead

Study Sites (3)

King Fahad Specialist Hospital

Jeddah, Jeddah, Saudi Arabia

Location

King Fahad Hospital

Madinah, Madinah, Saudi Arabia

Location

Prince Salman Hospital

Riyadh, Riyadh Region, Saudi Arabia

Location

Related Publications (1)

• Al-Eidi SM, Mohamed AG, Abutalib RA, AlBedah AM, Khalil MKM. Wet Cupping-Traditional Hijamah Technique versus Asian Cupping Technique in Chronic Low Back Pain Patients: A Pilot Randomized Clinical Trial. J Acupunct Meridian Stud. 2019 Dec;12(6):173-181. doi: 10.1016/j.jams.2019.04.005. Epub 2019 Apr 24.

  PMID: 31028971 DERIVED

Study Officials

• Abdullah M AlBedah, MD

  National Center for Complementary and Integrative Health (NCCIH)

  PRINCIPAL INVESTIGATOR

• Mohamed K.M. Khalil, MD

  National Center for Complementary and Integrative Health (NCCIH)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 16, 2013
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

SA (3)