Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

Muscle Spasticity Clinical Trial

Official title:

Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03816787
• Other study ID #: NIRS for Cupping Therapy
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: May 29, 2021

Study information

• Verified date: July 2019
• Source: Chinese Academy of Medical Sciences
• Contact: Ting Li
• Phone: 18002127296
• Email: t.li619[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 29, 2021
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Muscle Spasticity
• Oxygen Metabolism

Intervention

Procedure:
• Negative pressure therapy
Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?[HbO2]	the concentration changes of oxyhemoglobin (higher alternation means better curative effect)	all groups: up to 4 weeks
Primary	?[Hb]	the concentration changes of deoxyhemoglobin (higher alternation means better curative effect)	all groups: up to 4 weeks
Secondary	?[tHb]	the concentration changes of blood volume (higher alternation means better curative effect)	all groups: up to 4 weeks
Secondary	NRS	Numeric Rating Scale for pain (lower score means better curative effect)	experimental group: up to 4 weeks

External Links

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