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

NCT ID: NCT01167036

Last Updated: 2010-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myofascial Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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FascialEdge tool

A massage tool used to loosen adhesions in the superficial fascia

Group Type EXPERIMENTAL

FascialEdge instrument

Intervention Type DEVICE

Stroking massage to patient tolerance over the muscle

Placebo

Detuned electric point stimulation over the upper trapezius trigger point

Group Type PLACEBO_COMPARATOR

Placebo electric point stimulation

Intervention Type OTHER

Detuned electric point stimulation over the involved muscle

Interventions

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FascialEdge instrument

Stroking massage to patient tolerance over the muscle

Intervention Type DEVICE

Placebo electric point stimulation

Detuned electric point stimulation over the involved muscle

Intervention Type OTHER

Other Intervention Names

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FascialEdge tool Pointer Plus stimulator

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anglo-European College of Chiropractic

OTHER

Sponsor Role lead

Responsible Party

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Anglo-European College of Chiropractic

Principal Investigators

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Hugh Gemmell, DC, EdD

Role: PRINCIPAL_INVESTIGATOR

Anglo-European College of Chiropractic

Locations

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Anglo-European College of Chiropractic

Bournemouth, Dorset, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AECC 20091

Identifier Type: -

Identifier Source: org_study_id

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