NCT01635634

Brief Summary

The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2.1 years

First QC Date

July 3, 2012

Last Update Submit

May 4, 2018

Conditions

Keywords

FibromyalgiaCupping

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Pain on a 100mm visual analog scale

    Day 18

Secondary Outcomes (12)

  • Pain Intensity

    Day 200

  • Fatigue

    Day 18

  • Fatigue

    Day 200

  • Sleep Quality

    Day 18

  • Sleep Quality

    Day 200

  • +7 more secondary outcomes

Study Arms (3)

Sham Cupping

SHAM COMPARATOR

Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back

Other: Cupping therapy

Cupping Therapy

EXPERIMENTAL

Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back

Other: Cupping therapy

Wait list

NO INTERVENTION

Wait list control no specific intervention for 3 weeks study period

Interventions

Cups are placed at the skin; local suction is created on the skin; it mobilizes blood flow; the suction is created by a mechanical device (Pneumatron, Pneumed, Germany)

Cupping TherapySham Cupping

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FMS diagnosis according to AWMF Guidelines,
  • necessary documents: medical records
  • Pain intensity \> 45mm VAS
  • Participation in cupping twice weekly on appointment

You may not qualify if:

  • pregnancy
  • other study participation
  • pain due to other rheumatic disease
  • major psychiatric disorder
  • substance abuse
  • severe somatic disorder (cancer)
  • injections, acupuncture, neural therapy within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Naturheilkunde

Essen, 45276, Germany

Location

Related Publications (1)

  • Lauche R, Spitzer J, Schwahn B, Ostermann T, Bernardy K, Cramer H, Dobos G, Langhorst J. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial. Sci Rep. 2016 Nov 17;6:37316. doi: 10.1038/srep37316.

    PMID: 27853272BACKGROUND

Related Links

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cupping Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Jost Langhorst, MD, Prof

    University of Duisburg-Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 9, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2014

Study Completion

March 1, 2015

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations