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

This study has been completed.
Sponsor:
Information provided by:
Anglo-European College of Chiropractic
ClinicalTrials.gov Identifier:
NCT01167036
First received: July 20, 2010
Last updated: July 21, 2010
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention
Myofascial Pain Syndrome
 Device: FascialEdge instrument
Other: Placebo electric point stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Anglo-European College of Chiropractic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Pointer Plus stimulator

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167036

Locations
United Kingdom
Anglo-European College of Chiropractic
Bournemouth, Dorset, United Kingdom, BH5 2DF
Sponsors and Collaborators
Anglo-European College of Chiropractic
Investigators
Principal Investigator: Hugh Gemmell, DC, EdD Anglo-European College of Chiropractic
  More Information

No publications provided

Responsible Party: Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic
ClinicalTrials.gov Identifier: NCT01167036     History of Changes
Other Study ID Numbers: AECC 20091
Study First Received: July 20, 2010
Last Updated: July 21, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Anglo-European College of Chiropractic:
Myofascial pain syndrome
Trigger points, Myofascial
Chiropractic
Massage
Musculoskeletal manipulation

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Somatoform Disorders
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013