Massage of the Low Back Muscles Assessed With Ultrasound Scanning

August 3, 2010 updated by: Anglo-European College of Chiropractic

Effect of Fascial Release on Connective Tissue Structure in Human Subjects With Chronic Low Back Pain as Determined by Ultrasound Imaging: a Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fascial massage
A specific type of fascial massage to release restricted lumbodorsal fascia.
Procedure: Specific massage for fascial release
Patient will receive a 3 minute massage to reduce restrictions in the lumbodorsal fascia.
Other Names:
  • Superficial fascial release
No Intervention: No treatment control
Patient will rest quietly without receiving any instruction.
Other: Quiet non-instructed rest for 3 minutes
Patient will lay quietly without any instructions on how to relax.
Other Names:
  • Uninstructed rest

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anglo-European College of Chiropractic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Estimate)

August 4, 2010

Last Update Submitted That Met QC Criteria

August 3, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AECC 290710

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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