Effectiveness of a Massage Instrument Compared to Placebo for Upper Trapezius Muscle Pain

July 21, 2010 updated by: Anglo-European College of Chiropractic

Immediate Effectiveness of Instrument Assisted Soft Tissue Mobilization Compared to Placebo on the Sensitivity of Latent Upper Trapezius Trigger Points: A Randomized Double Blind, Placebo-controlled, Parallel-group Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study was to determine if a statistically significant and clinically meaningful difference exits between the FascialEdge tool and placebo in the treatment of latent upper trapezius trigger points.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH5 2DF
        • Anglo-European College of Chiropractic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FascialEdge tool
A massage tool used to loosen adhesions in the superficial fascia
Device: FascialEdge instrument
Stroking massage to patient tolerance over the muscle
Other Names:
  • FascialEdge tool
PLACEBO_COMPARATOR: Placebo
Detuned electric point stimulation over the upper trapezius trigger point
Other: Placebo electric point stimulation
Detuned electric point stimulation over the involved muscle
Other Names:
  • Pointer Plus stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pressure pain threshold over the upper trapezius muscles as determined with a pressure pain algometer
Time Frame: Within five minutes after initial and only treatment
Within five minutes after initial and only treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anglo-European College of Chiropractic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (ESTIMATE)

July 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2010

Last Update Submitted That Met QC Criteria

July 21, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AECC 20091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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