Clinical trial NCT02012205: Wet Cupping in Non-specific Low Back Pain
Official title: Safety and Efficacy of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Controlled, Open-label, Parallel-group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Non Specific Low Back Pain
Keywords: wet cupping - back pain - NSLBP - Saudi
Lead sponsor: National Center for Complementary and Alternative Medicine, Saudi Arabia
Sponsor class: OTHER_GOV
First posted: 2013-12-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: NRS
timeFrame: at the end of the two weeks wet cupping sessions.
Secondary outcomes:
measure: Scores of the McGill Pain questionnaire for pain intensity (PPI)
timeFrame: at the end of two weeks of cupping sessions and two weeks later
measure: the Oswestry Disability Questionnaire (ODQ),
timeFrame: at the end of two weeks of cupping sessions and two weeks later
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: at the last visit, one week after the end of the last sessions
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Fahad Specialist Hospital
city: Madinah
country: Saudi Arabia
facility: King Fahad Hospital
city: Riyadh
country: Saudi Arabia
facility: Prince Salman Hospital
Study officials:
affiliation: National Center for Complementary and Integrative Health (NCCIH)
name: Abdullah M AlBedah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Complementary and Integrative Health (NCCIH)
name: Mohamed K.M. Khalil, MD
role: STUDY_DIRECTOR
References:
citation: 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.