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

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ClinicalTrials.gov Identifier: NCT01167036
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Myofascial Pain Syndrome Device: FascialEdge instrument Other: Placebo electric point stimulation

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2009
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic
U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic
ClinicalTrials.gov Identifier: NCT01167036     History of Changes
Other Study ID Numbers: AECC 20091
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: August 2009

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
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases