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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05392283
Other study ID # VC2022-1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2022
Est. completion date June 30, 2022

Study information

Verified date April 2022
Source Jena University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Small clinical pilot studies have shown that vacuum massage-related techniques such as traditional dry cupping can reduce musculoskeletal pain such as back and neck pain. At the same time, little is yet known about the potential mechanisms of action of these therapies. A vacuum pump induces a massaging effect of the skin including the deeper tissue layers. The resulting massage technique corresponds to a kind of tissue manipulation similar to dry cupping. In this procedure, suction force and air flow can be individually adjusted. This is an advantage that can be used for patients with varying degrees of sensitivity or who are preloaded by patients with varying degrees of sensitivity or a history of pain. The aim of this study is to investigate the mechanisms of action of the therapeutic effects of the vacuum cupping in chronic neck or back pain using the biomarker QST.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date June 30, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - chronic neck or back pain - mean pain intensity = 40 mm VAS Exclusion Criteria: - neurological symptoms or neuropathic pain - vertebral column surgery less than 12 months prior to the study - TENS, acupuncture, osteopathy, or a chiropractic maneuvre or infiltration at the area within 4 weeks prior to the inclusion in the study - congenital deformation of the spine

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AERO vacuum cupping device
The treatment consists of 5 sessions (approx. 30 min) of vacuum massage. The vacuum pump provided by the device provides a type of vacuum massage, that can be adjusted according to applied suction and air flow. The resulting massage technique provides a type of soft tissue manipulation similar to the ancient traditional medicine technique of cupping. Nonetheless, this automated technique allows for more precise determination of the massage characteristics.

Locations

Country Name City State
Germany Jena University Hospital Jena

Sponsors (4)

Lead Sponsor Collaborator
Jena University Hospital Helheten Norway, National Research Centre of Complementary and Alternative Medicine, Norway, University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity (Numeric rating scale (NRS)) NRS is a 11-point pain scale for self-reporting of pain ("0" meaning "no pain" and "10" meaning "worst pain") measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment
Secondary Quantitative sensory testing (QST) QST is a diagnostic tool which allows measurement of pain sensitivity. measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment
Secondary Neck Disability Index (NDI) NDI is used to measure neck pain and to quantify disability for neck pain. measured at baseline (week 1), at the end of treatment (week 5) and after 1 month after last treatmentekly during treatment (week 2 to 5) and 1 month after last treatment
Secondary Oswestry Disability Index (ODI) ODI is used to measure low back pain and to quantify disability for low back pain. measured at baseline (week 1), at the end of treatment (week 5) and after 1 month after last treatment
Secondary Pain diary A pain diary helps to track pain in the course of the study. filled in from baseline (week 1) until last treatment (week 5)
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