Vacuum Cupping for Chronic Neck and Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Vacuum Cupping for Chronic Neck and Back Pain

Conditions
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Chronic Pain, Neck Pain, Back Pain

Intervention / Treatment
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* Device: AERO vacuum cupping device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vacuum cupping<br> | Device: AERO vacuum cupping device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vacuum cupping, Quantitative sensory testing