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Massage of the Low Back Muscles Assessed With Ultrasound Scanning

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Anglo-European College of Chiropractic.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Anglo-European College of Chiropractic
ClinicalTrials.gov Identifier:
NCT01174667
First received: August 2, 2010
Last updated: August 3, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Myofascial Pain Syndrome
 Procedure: Specific massage for fascial release
Other: Quiet non-instructed rest for 3 minutes
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Anglo-European College of Chiropractic:

Primary Outcome Measures:
  • Thickness of lumbodorsal fascia determined by ultrasound imaging [ Time Frame: An average of 5 minutes from the the end of first treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Uninstructed rest

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174667

Contacts
Contact: Hugh Gemmell, DC, EdD 441202436268 ext 268 hgemmell@aecc.ac.uk
Contact: Jane Cook, DC, MSc 441202436200 ext 208 janecook@aecc.ac.uk

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: NCT01174667     History of Changes
Other Study ID Numbers: AECC 290710
Study First Received: August 2, 2010
Last Updated: August 3, 2010
Health Authority: United Kingdom: Department of Health

Keywords provided by Anglo-European College of Chiropractic:
Myofascial pain
Trigger points

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013