Effectiveness of a Massage Instrument Compared to Placebo... | NCT01167036

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

NCT01167036

Sponsor

Anglo-European College of Chiropractic

Status

Completed

Last Update Posted

Jul 22, 2010Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Myofascial Pain Syndrome

Interventions

FascialEdge instrument
Placebo electric point stimulation

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Jul 20, 2010

First Submission Date that Met QC Criteria

Jul 21, 2010

First Posted Date

Jul 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2010

Last Update Posted Date

Jul 22, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FascialEdge tool	Experimental	A massage tool used to loosen adhesions in the superficial fascia	Device: FascialEdge instrument
Placebo	Placebo Comparator	Detuned electric point stimulation over the upper trapezius trigger point	Other: Placebo electric point stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FascialEdge instrument	Device	Stroking massage to patient tolerance over the muscle	FascialEdge tool

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pressure pain threshold over the upper trapezius muscles as determined with a pressure pain algometer		Within five minutes after initial and only treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugh Gemmell, DC, EdD	Anglo-European College of Chiropractic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anglo-European College of Chiropractic		Bournemouth	Dorset	BH5 2DF	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009209	Myofascial Pain Syndromes

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided