Massage of the Low Back Muscles Assessed With Ultrasound... | NCT01174667

Studies
Massage of the Low Back Muscles Assessed With Ultrasound Scanning

NCT01174667

Sponsor

Anglo-European College of Chiropractic

Status

Unknown status

Last Update Posted

Aug 4, 2010Estimated

Enrollment

70Estimated

Phase

Phase 1Phase 2

Conditions

Myofascial Pain Syndrome

Interventions

Specific massage for fascial release
Quiet non-instructed rest for 3 minutes

Countries

Not provided

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

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Aug 2, 2010

First Submission Date that Met QC Criteria

Aug 3, 2010

First Posted Date

Aug 4, 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

Aug 3, 2010

Last Update Posted Date

Aug 4, 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 aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues in the low back in a group of patients with chronic low back pain treated with massage to a control group of non-treated patients.

It is hypothesized that on average, soft tissue thickness in the lumbar region will change in the group receiving massage compared to the control group.

Detailed Description

A specialized form of massage designed to reduce fascial restrictions will be compared to a no-treatment control group based on a change in thickness of the lumbodorsal fascia as determined by ultrasound imaging.

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fascial massage	Experimental	A specific type of fascial massage to release restricted lumbodorsal fascia.	Procedure: Specific massage for fascial release
No treatment control	No Intervention	Patient will rest quietly without receiving any instruction.	Other: Quiet non-instructed rest for 3 minutes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Specific massage for fascial release	Procedure	Patient will receive a 3 minute massage to reduce restrictions in the lumbodorsal fascia.	Fascial massage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thickness of lumbodorsal fascia determined by ultrasound imaging		An average of 5 minutes from the the end of first treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of chronic low back pain far at least 3 months
Able to read and write English
Between 18-64 years of age

Exclusion Criteria:

Prior lumbar surgery
Infected or broken skin over the lumbodorsal fascia
Major structural spinal deformity
Specific cause of low back pain, such as tumor, infection, fracture
Bleeding disorders or use of anticoagulant medications
Pregnancy
Litigation for low back pain
Systemic infection

Accepts Healthy Volunteers

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

Name	Role	Phone	Extension	Email
Hugh Gemmell, DC, EdD	Contact	441202436268	268	hgemmell@aecc.ac.uk
Jane Cook, DC, MSc	Contact	441202436200	208	janecook@aecc.ac.uk

Overall Officials

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

Locations

Not provided

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