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

Myofascial Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167036
• Other study ID #: AECC 20091
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: July 21, 2010
• Start date: September 2009
• Est. completion date: January 2010

Study information

• Verified date: August 2009
• Source: Anglo-European College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes

Intervention

Device:
• FascialEdge instrument
Stroking massage to patient tolerance over the muscle

Other:
• Placebo electric point stimulation
Detuned electric point stimulation over the involved muscle

Locations

Country	Name	City	State
United Kingdom	Anglo-European College of Chiropractic	Bournemouth	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
Anglo-European College of Chiropractic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure pain threshold over the upper trapezius muscles as determined with a pressure pain algometer		Within five minutes after initial and only treatment	No