Chronic Pain Clinical Trial
Official title:
Vacuum Cupping for Chronic Neck and Back Pain
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 |
Verified date | April 2022 |
Source | Jena University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Jena University Hospital | Jena |
Lead Sponsor | Collaborator |
---|---|
Jena University Hospital | Helheten Norway, National Research Centre of Complementary and Alternative Medicine, Norway, University of Jena |
Germany,
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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