Vacuum Cupping for Chronic Neck and Back Pain

Sponsor
Jena University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05392283
Collaborator
University of Jena (Other), Helheten Norway (Other), National Research Centre of Complementary and Alternative Medicine, Norway (Other)
6
1
1
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3.1

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: AERO vacuum cupping device
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vacuum Cupping for Chronic Neck and Back Pain
Actual Study Start Date :
May 2, 2022
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pain intensity (Numeric rating scale (NRS)) [measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment]

    NRS is a 11-point pain scale for self-reporting of pain ("0" meaning "no pain" and "10" meaning "worst pain")

Secondary Outcome Measures

  1. Quantitative sensory testing (QST) [measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment]

    QST is a diagnostic tool which allows measurement of pain sensitivity.

  2. 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]

    NDI is used to measure neck pain and to quantify disability for neck pain.

  3. Oswestry Disability Index (ODI) [measured at baseline (week 1), at the end of treatment (week 5) and after 1 month after last treatment]

    ODI is used to measure low back pain and to quantify disability for low back pain.

  4. Pain diary [filled in from baseline (week 1) until last treatment (week 5)]

    A pain diary helps to track pain in the course of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jena University Hospital Jena Germany 07747

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jena University Hospital
ClinicalTrials.gov Identifier:
NCT05392283
Other Study ID Numbers:
  • VC2022-1.0
First Posted:
May 26, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jena University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022