Vacuum Cupping for Chronic Neck and Back Pain

NCT05392283 | Completed

• 1 other identifier: VC2022-1.0
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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 was to test the feasibility of the study design.

Conditions

Chronic Pain; Neck Pain; Back Pain

Keywords

Vacuum cupping; Quantitative sensory testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quantitative sensory testing (QST)

  measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment

• Neck Disability Index (NDI)

  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)

  measured at baseline (week 1), at the end of treatment (week 5) and after 1 month after last treatment

• Pain diary

  filled in from baseline (week 1) until last treatment (week 5)

Study Arms (1)

Vacuum cupping

EXPERIMENTAL

Device: AERO vacuum cupping device

Interventions

AERO vacuum cupping device 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.

Vacuum cupping

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic neck or back pain
• mean pain intensity ≥ 40 mm VAS

You may not qualify if:

• neurological symptoms or neuropathic pain
• vertebral column surgery less than 12 months prior to the study
• congenital deformation of the spine

Sponsors & Collaborators

• Jena University Hospital: lead
• University of Jena: collaborator
• Helheten Norway: collaborator
• National Research Centre of Complementary and Alternative Medicine, Norway: collaborator

Study Sites (1)

Jena University Hospital

Jena, 07747, Germany

Location

MeSH Terms

Conditions

Chronic Pain; Neck Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 26, 2022
• Study Start: May 2, 2022
• Primary Completion: July 31, 2022
• Study Completion: August 30, 2022
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

DE (1)