Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

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.

Study Overview

• Status: Unknown
• Conditions: Muscle Spasticity; Oxygen Metabolism
• Intervention / Treatment: Procedure: Negative pressure therapy

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Li; Phone Number: 18002127296; Email: t.li619@foxmail.com
• Study Contact Backup: Name: Chenyang Gao; Phone Number: 16622803399; Email: gaocy@bme.cams.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dry cupping for patients of low back pain; Patients will receive four consecutive dry cupping therapy application in one month.	Procedure: Negative pressure therapy; Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks; Other Names: Dry cupping therapy
Active Comparator: dry cupping for health people; Health people will receive four consecutive dry cupping therapy application in one month.	Procedure: Negative pressure therapy; Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks; Other Names: Dry cupping therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

Helpful Links

• Significant and sustaining elevation of blood oxygen induced by Chinese cupping therapy as assessed by near-infrared spectroscopy

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): November 25, 2020
• Study Completion (Anticipated): May 29, 2021

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Near Infrared Spectroscopy; Cupping Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Back Pain; Low Back Pain; Muscle Spasticity
• Other Study ID Numbers: NIRS for Cupping Therapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No