Wet Cupping in Non-specific Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Center for Complementary and Alternative Medicine, Saudi Arabia
Sponsor:
Information provided by (Responsible Party):
National Center for Complementary and Alternative Medicine, Saudi Arabia
ClinicalTrials.gov Identifier:
NCT02012205
First received: December 3, 2013
Last updated: July 13, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Persistent Non Specific Low Back Pain
Procedure: wet cupping

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine, Saudi Arabia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 45
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)
Arms Assigned Interventions
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
not cupping

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:

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012205

Contacts
Contact: Mohamed KM Khalil 00966504955087 STATKHL@HOTMAIL.COM

Locations
Saudi Arabia
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         
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine, Saudi Arabia
Investigators
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)
  More Information

No publications provided

Responsible Party: National Center for Complementary and Alternative Medicine, Saudi Arabia
ClinicalTrials.gov Identifier: NCT02012205     History of Changes
Other Study ID Numbers: MOH044
Study First Received: December 3, 2013
Last Updated: July 13, 2014
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by National Center for Complementary and Alternative Medicine, Saudi Arabia:
wet cupping - back pain - NSLBP - Saudi

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014