NCT02631382

Brief Summary

Randomized clinical trial to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 22, 2016

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

December 6, 2015

Last Update Submit

September 20, 2016

Conditions

Low Back Pain

Keywords

wet cupping Saudi Arabia

Outcome Measures

Primary Outcomes (1)

  • Pain Numeric rating scale (NRS) before and after intervention

    numeric pain scale to be measured before intervention then two weeks after

    14 DAYS

Secondary Outcomes (3)

  • pain: McGill, Persistent Pain Intensity (PPI)

    14 days

  • functioning (Disability) using the Oswestry Disability Questionnaire (ODQ)

    14 days

  • the Safety of the two wet cupping techniques, by collecting safety data after two weeks of the intervention

    up to 14 days

Other Outcomes (1)

  • Patient satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS)

    up to 14 days

Study Arms (2)

wet cupping : double cupping

EXPERIMENTAL

wet cupping: (traditional cupping technique): cupping (suction) - Scarification - cupping (suction)

Procedure: wet cupping

wet cupping: single cupping

EXPERIMENTAL

wet cupping:(Asian cupping): Puncture by needles then cupping (suction):

Procedure: wet cupping

Interventions

wet cuppingPROCEDURE

In double cupping (traditional technique): Cupping (suction) then scarification then cupping (suction). In single cupping (Asian): puncture using auto lancet then cupping (suction). In both techniques 4 out of 6 acupoints (BL23, BL24, BL25 bilateral) will be selected.

Also known as: Hijamah, wet cupping device
wet cupping : double cuppingwet cupping: single cupping

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and Female
  • Age equal or more than 18 years up to 60 years
  • Chronic low back pain (at least the duration ≥ 3 months)
  • Not on anti-inflammatory or pain killers for the last 15 days.

You may not qualify if:

  • Patients received wet-cupping therapy before in the last three months
  • Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, and cauda equinal syndrome)
  • Patients who are inappropriate to the wet cupping treatment (AIDS, Hepatitis, Tuberculosis, Syphilis. The referring physicians will be advised to exclude those patients)
  • Patients currently receiving any anticoagulant, antiplatelet medications
  • Anemia, thrombocytopenia, Coagulopathy or Hemorrhagic disease like hemophilia
  • Had undergone a surgery, or had bleeding injury, or had blood donation
  • Uncontrolled hypertension, Ischemic heart disease, previous transient ischemic attack or stroke
  • Diabetes, known renal and / or hepatic diseases
  • Patients who are in pregnancy or have plan to conception
  • Previously or currently drug addicts
  • Any other severe disease or disabling medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King Fahad Hospital

Jeddah, Jeddah, Saudi Arabia

Location

King Fahad Hospital

Madinah, Madinah, Saudi Arabia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sulaiman AlEidi, MBBS

    NCCAM , MOH, Riyadh, Saudi Arabia

    PRINCIPAL INVESTIGATOR

  • Mohamed Khalil, MD

    NCCAM.MOH

    STUDY CHAIR

  • Ashry Gad Mohamed, MD

    King Saud University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2015

First Posted

December 16, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 22, 2016

Record last verified: 2015-12

Locations

SA(2)