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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014