NCT01500330

Brief Summary

The purpose of this randomized controlled study is to determine the effectiveness of cupping massage as home use for patients with chronic nonspecific neck pain compared to relaxation exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 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

First Submitted

Initial submission to the registry

December 22, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

4 months

First QC Date

December 22, 2011

Last Update Submit

October 8, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Pain intensity on a 100mm visual analogue scale

    T2 (84 days)

Secondary Outcomes (9)

  • Pain diary

    week 12

  • pain intensity in motion

    T2 (84 days)

  • pain quality

    T2 (84 days)

  • well being

    T2 (84 days)

  • Quality of life

    T2 (84 days)

  • +4 more secondary outcomes

Study Arms (2)

cupping massage

EXPERIMENTAL

12 weeks home use of cupping massage (delivered by the partner or friend) twice a week for 20 minutes

Procedure: cupping massage

control group

ACTIVE COMPARATOR

progressive muscle relaxation twice a week for 20 minutes

Procedure: Progressive muscle relaxation

Interventions

the upper back is covered in massage oil the cupping glass is drawn along the back muscles

cupping massage

standardized programme on muscle relaxation according to Jacobson

control group

Eligibility Criteria

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

You may qualify if:

  • mean neck pain intensity 45mm
  • neck pain for at least 3 months
  • age 18-75
  • partner or friend for the application of the massage

You may not qualify if:

  • specific neck pain due to trauma, neurological disorder, prolapse, operation, cancer
  • severe deformity of the spine
  • skin disease, allergy on the neck area
  • hemophilia, anticoagulation, antiplatelet disorder
  • severe psychiatric disorder
  • severe comorbidity
  • regular intake of opiates and corticosteroids \>10mg prednisolon
  • pregnancy
  • participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Naturheilkunde

Essen, Germany

Location

Related Publications (1)

  • Lauche R, Materdey S, Cramer H, Haller H, Stange R, Dobos G, Rampp T. Effectiveness of home-based cupping massage compared to progressive muscle relaxation in patients with chronic neck pain--a randomized controlled trial. PLoS One. 2013 Jun 7;8(6):e65378. doi: 10.1371/journal.pone.0065378. Print 2013.

Related Links

MeSH Terms

Conditions

Neck Pain

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Thomas Rampp, MD

    Chair of Complementary and Integrative Medicine, University Duisburg-Essen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study coordinator

Study Record Dates

First Submitted

December 22, 2011

First Posted

December 28, 2011

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations