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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

July 20, 2010
July 21, 2010
September 2009
January 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01167036 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of a Massage Instrument Compared to Placebo for Upper Trapezius Muscle Pain
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Myofascial Pain Syndrome
  • Device: FascialEdge instrument
    Stroking massage to patient tolerance over the muscle
    Other Name: FascialEdge tool
  • Other: Placebo electric point stimulation
    Detuned electric point stimulation over the involved muscle
    Other Name: Pointer Plus stimulator
  • Experimental: FascialEdge tool
    A massage tool used to loosen adhesions in the superficial fascia
    Intervention: Device: FascialEdge instrument
  • Placebo Comparator: Placebo
    Detuned electric point stimulation over the upper trapezius trigger point
    Intervention: Other: Placebo electric point stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01167036
AECC 20091
No
Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic
Anglo-European College of Chiropractic
Not Provided
Principal Investigator: Hugh Gemmell, DC, EdD Anglo-European College of Chiropractic
Anglo-European College of Chiropractic
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP