Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

Not Applicable

• Conditions: Muscle Spasticity; Oxygen Metabolism
• Interventions: Procedure: Negative pressure therapy

• Registration Number: NCT03816787
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on low back pain. 50 patients with low back pain as experimental group and 50 healthy people as control group are treated by DCT. They will receive four consecutive WCT application in one month. Optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin (\[HbO2\]), deoxy-hemoglobin (\[Hb\]) and the derived change in blood volume (\[tHb\]) in/surround the cupping sites during treatment. The investigators hope to interpret the curative effect of DCT from the perspective of modern hemodynamics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24
• Study Start: 2019-12-01
• Primary Completion: 2020-11-25
• Study Completion: 2021-05-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients who have had non-specific low back pains at least 12 weeks now.
• Healthy people who are interested in dry cupping therapy

Exclusion Criteria

• Patients who have had non-specific low back pains at least 12 weeks now.
• Healthy people who are interested in dry cupping therapy

Exclusion Criteria:

• 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
  • 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.

• Patients who have had treatment for low back pain during last 2 weeks.

• Patients who are in pregnancy or have plan to conception.

• Patients who have vertebra surgery or have plan of surgery.

• Patients who are inappropriate to join this trial judged by the radiologists or specialists.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dry cupping for patients of low back pain	Negative pressure therapy	Patients will receive four consecutive dry cupping therapy application in one month.
dry cupping for health people	Negative pressure therapy	Health people will receive four consecutive dry cupping therapy application in one month.

Primary Outcome Measures

Name	Time	Method
Δ[HbO2]	all groups: up to 4 weeks	the concentration changes of oxyhemoglobin (higher alternation means better curative effect)
Δ[Hb]	all groups: up to 4 weeks	the concentration changes of deoxyhemoglobin (higher alternation means better curative effect)

Secondary Outcome Measures

Name	Time	Method
Δ[tHb]	all groups: up to 4 weeks	the concentration changes of blood volume (higher alternation means better curative effect)
NRS	experimental group: up to 4 weeks	Numeric Rating Scale for pain (lower score means better curative effect)