Vacuum Cupping for Chronic Neck and Back Pain

Vacuum Cupping for Chronic Neck and Back Pain - a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Chronic Pain; Neck Pain
• Intervention / Treatment: Device: AERO vacuum cupping device

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Jena, Germany, 07747
    • Jena University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Vacuum cupping

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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: University of Jena; National Research Centre of Complementary and Alternative Medicine, Norway; Helheten Norway

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Quantitative sensory testing; Vacuum cupping
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Chronic Pain; Neck Pain
• Other Study ID Numbers: VC2022-1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No