NCT01167036

Brief Summary

The purpose of this study was to determine if using a specialized massage tool was more effective than a placebo treatment in relieving pain in the upper trapezius muscle along the top of the shoulder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
Last Updated

July 22, 2010

Status Verified

August 1, 2009

Enrollment Period

4 months

First QC Date

July 20, 2010

Last Update Submit

July 21, 2010

Conditions

Myofascial Pain Syndrome

Keywords

Myofascial pain syndromeTrigger points, MyofascialChiropracticMassageMusculoskeletal manipulation

Outcome Measures

Primary Outcomes (1)

  • Pressure pain threshold over the upper trapezius muscles as determined with a pressure pain algometer

    Within five minutes after initial and only treatment

Study Arms (2)

FascialEdge tool

EXPERIMENTAL

A massage tool used to loosen adhesions in the superficial fascia

Device: FascialEdge instrument

Placebo

PLACEBO COMPARATOR

Detuned electric point stimulation over the upper trapezius trigger point

Other: Placebo electric point stimulation

Interventions

FascialEdge instrumentDEVICE

Stroking massage to patient tolerance over the muscle

Also known as: FascialEdge tool
FascialEdge tool
Placebo electric point stimulationOTHER

Detuned electric point stimulation over the involved muscle

Also known as: Pointer Plus stimulator
Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male or female
  • between 18-64 years of age
  • a latent trigger point of the upper trapezius muscle

You may not qualify if:

  • an active trigger point of the upper trapezius muscle
  • rash or infection of the skin over the trigger point
  • neck pain
  • taking anticoagulant drugs
  • spontaneous bleeding
  • long term corticosteroid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anglo-European College of Chiropractic

Bournemouth, Dorset, BH5 2DF, United Kingdom

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Hugh Gemmell, DC, EdD

    Anglo-European College of Chiropractic

    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

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 22, 2010

Study Start

September 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 22, 2010

Record last verified: 2009-08

Locations

GB(1)