NCT03816787

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Status
unknown

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

First Submitted

Initial submission to the registry

January 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2021

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

12 months

First QC Date

January 20, 2019

Last Update Submit

July 22, 2019

Conditions

Oxygen MetabolismMuscle Spasticity

Keywords

Cupping TherapyNear Infrared Spectroscopy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Δ[tHb]

    all groups: up to 4 weeks

  • NRS

    experimental group: up to 4 weeks

Study Arms (2)

dry cupping for patients of low back pain

EXPERIMENTAL

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

Procedure: Negative pressure therapy

dry cupping for health people

ACTIVE COMPARATOR

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

Procedure: Negative pressure therapy

Interventions

Negative pressure therapyPROCEDURE

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

Also known as: Dry cupping therapy
dry cupping for health peopledry cupping for patients of low back pain

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients who have had non-specific low back pains at least 12 weeks now.
  • Healthy people who are interested in dry cupping therapy
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Central Study Contacts

Ting Li

CONTACT

18002127296t.li619@foxmail.com

Chenyang Gao

CONTACT

16622803399gaocy@bme.cams.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 20, 2019

First Posted

January 25, 2019

Study Start

December 1, 2019

Primary Completion

November 25, 2020

Study Completion

May 29, 2021

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share