Back to results

Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

Primary Purpose

Oxygen Metabolism, Muscle Spasticity

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Negative pressure therapy

About this trial

This is an interventional supportive care trial for Oxygen Metabolism focused on measuring Cupping Therapy, Near Infrared Spectroscopy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dry cupping for patients of low back pain

dry cupping for health people

Arm Description

Patients will receive four consecutive dry cupping therapy application in one month.

Health people will receive four consecutive dry cupping therapy application in one month.

Outcomes

Primary Outcome Measures

Δ[HbO2]

the concentration changes of oxyhemoglobin (higher alternation means better curative effect)

Δ[Hb]

the concentration changes of deoxyhemoglobin (higher alternation means better curative effect)

Secondary Outcome Measures

Δ[tHb]

the concentration changes of blood volume (higher alternation means better curative effect)

NRS

Numeric Rating Scale for pain (lower score means better curative effect)

Full Information

NCT ID

NCT03816787

First Posted

January 20, 2019

Last Updated

July 22, 2019

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03816787

Brief Title

Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

Official Title

Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Anticipated)

Primary Completion Date

November 25, 2020 (Anticipated)

Study Completion Date

May 29, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oxygen Metabolism, Muscle Spasticity

Keywords

Cupping Therapy, Near Infrared Spectroscopy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dry cupping for patients of low back pain

Arm Type

Experimental

Arm Description

Patients will receive four consecutive dry cupping therapy application in one month.

Arm Title

dry cupping for health people

Arm Type

Active Comparator

Arm Description

Health people will receive four consecutive dry cupping therapy application in one month.

Intervention Type

Procedure

Intervention Name(s)

Negative pressure therapy

Other Intervention Name(s)

Dry cupping therapy

Intervention Description

Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks

Primary Outcome Measure Information:

Title

Δ[HbO2]

Description

the concentration changes of oxyhemoglobin (higher alternation means better curative effect)

Time Frame

all groups: up to 4 weeks

Title

Δ[Hb]

Description

the concentration changes of deoxyhemoglobin (higher alternation means better curative effect)

Time Frame

all groups: up to 4 weeks

Secondary Outcome Measure Information:

Title

Δ[tHb]

Description

the concentration changes of blood volume (higher alternation means better curative effect)

Time Frame

all groups: up to 4 weeks

Title

NRS

Description

Numeric Rating Scale for pain (lower score means better curative effect)

Time Frame

experimental group: up to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ting Li

Phone

18002127296

t.li619@foxmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chenyang Gao

Phone

16622803399

gaocy@bme.cams.cn

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.osapublishing.org/boe/abstract.cfm?uri=boe-8-1-223

Description

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

Learn more about this trial

Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

We'll reach out to this number within 24 hrs