search
Back to results

Vacuum Cupping for Chronic Neck and Back Pain

Primary Purpose

Chronic Pain, Neck Pain, Back Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
AERO vacuum cupping device
Sponsored by
Jena University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Vacuum cupping, Quantitative sensory testing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jena University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vacuum cupping

Arm Description

Outcomes

Primary Outcome Measures

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")

Secondary Outcome Measures

Quantitative sensory testing (QST)
QST is a diagnostic tool which allows measurement of pain sensitivity.
Neck Disability Index (NDI)
NDI is used to measure neck pain and to quantify disability for neck pain.
Oswestry Disability Index (ODI)
ODI is used to measure low back pain and to quantify disability for low back pain.
Pain diary
A pain diary helps to track pain in the course of the study.

Full Information

First Posted
April 26, 2022
Last Updated
August 10, 2022
Sponsor
Jena University Hospital
Collaborators
University of Jena, Helheten Norway, National Research Centre of Complementary and Alternative Medicine, Norway
search

1. Study Identification

Unique Protocol Identification Number
NCT05392283
Brief Title
Vacuum Cupping for Chronic Neck and Back Pain
Official Title
Vacuum Cupping for Chronic Neck and Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jena University Hospital
Collaborators
University of Jena, Helheten Norway, National Research Centre of Complementary and Alternative Medicine, Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Neck Pain, Back Pain
Keywords
Vacuum cupping, Quantitative sensory testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vacuum cupping
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AERO vacuum cupping device
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity (Numeric rating scale (NRS))
Description
NRS is a 11-point pain scale for self-reporting of pain ("0" meaning "no pain" and "10" meaning "worst pain")
Time Frame
measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment
Secondary Outcome Measure Information:
Title
Quantitative sensory testing (QST)
Description
QST is a diagnostic tool which allows measurement of pain sensitivity.
Time Frame
measured at baseline (week 1) and weekly during treatment (week 2 to 5) and 1 month after last treatment
Title
Neck Disability Index (NDI)
Description
NDI is used to measure neck pain and to quantify disability for neck pain.
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
Title
Oswestry Disability Index (ODI)
Description
ODI is used to measure low back pain and to quantify disability for low back pain.
Time Frame
measured at baseline (week 1), at the end of treatment (week 5) and after 1 month after last treatment
Title
Pain diary
Description
A pain diary helps to track pain in the course of the study.
Time Frame
filled in from baseline (week 1) until last treatment (week 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jena University Hospital
City
Jena
ZIP/Postal Code
07747
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Vacuum Cupping for Chronic Neck and Back Pain

We'll reach out to this number within 24 hrs