Massage of the Low Back Muscles Assessed With Ultrasound Scanning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01174667
Recruitment Status : Unknown
Verified July 2010 by Anglo-European College of Chiropractic.
Recruitment status was:  Not yet recruiting
First Posted : August 4, 2010
Last Update Posted : August 4, 2010
Information provided by:
Anglo-European College of Chiropractic

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.

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

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  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

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 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

Primary Outcome Measures :
  1. Thickness of lumbodorsal fascia determined by ultrasound imaging [ Time Frame: An average of 5 minutes from the the end of first treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01174667

Contact: Hugh Gemmell, DC, EdD 441202436268 ext 268
Contact: Jane Cook, DC, MSc 441202436200 ext 208

Sponsors and Collaborators
Anglo-European College of Chiropractic
Principal Investigator: Hugh Gemmell, DC, EdD Anglo-European College of Chiropractic

Responsible Party: Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic Identifier: NCT01174667     History of Changes
Other Study ID Numbers: AECC 290710
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: August 4, 2010
Last Verified: July 2010

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

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