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

Primary Purpose

Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
FascialEdge instrument
Placebo electric point stimulation
Sponsored by
Anglo-European College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial pain syndrome, Trigger points, Myofascial, Chiropractic, Massage, Musculoskeletal manipulation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Anglo-European College of Chiropractic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FascialEdge tool

Placebo

Arm Description

A massage tool used to loosen adhesions in the superficial fascia

Detuned electric point stimulation over the upper trapezius trigger point

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 20, 2010
Last Updated
July 21, 2010
Sponsor
Anglo-European College of Chiropractic
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1. Study Identification

Unique Protocol Identification Number
NCT01167036
Brief Title
Effectiveness of a Massage Instrument Compared to Placebo for Upper Trapezius Muscle Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Anglo-European College of Chiropractic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
Myofascial pain syndrome, Trigger points, Myofascial, Chiropractic, Massage, Musculoskeletal manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FascialEdge tool
Arm Type
Experimental
Arm Description
A massage tool used to loosen adhesions in the superficial fascia
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Detuned electric point stimulation over the upper trapezius trigger point
Intervention Type
Device
Intervention Name(s)
FascialEdge instrument
Other Intervention Name(s)
FascialEdge tool
Intervention Description
Stroking massage to patient tolerance over the muscle
Intervention Type
Other
Intervention Name(s)
Placebo electric point stimulation
Other Intervention Name(s)
Pointer Plus stimulator
Intervention Description
Detuned electric point stimulation over the involved muscle
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Gemmell, DC, EdD
Organizational Affiliation
Anglo-European College of Chiropractic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anglo-European College of Chiropractic
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH5 2DF
Country
United Kingdom

12. IPD Sharing Statement

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

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