Vacuum Cupping for Chronic Neck and Back Pain

Chronic Pain Clinical Trial

Official title:

Vacuum Cupping for Chronic Neck and Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05392283
• Other study ID #: VC2022-1.0
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Neck Pain

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)