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Completed

NCT Number: NCT05392283

Vacuum Cupping for Chronic Neck and Back Pain

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.

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Key information

Conditions

Chronic Pain Back Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jena University Hospital

Jena, 07747, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain intensity (Numeric rating scale (NRS))

    Time frame: 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 outcomes

  1. Quantitative sensory testing (QST)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

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

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

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 26, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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