Massage of the Low Back Muscles Assessed With Ultrasound Scanning

Myofascial Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01174667
• Other study ID #: AECC 290710
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: August 2, 2010
• Last updated: August 3, 2010
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2010
• Source: Anglo-European College of Chiropractic
• Contact: Hugh Gemmell, DC, EdD
• Phone: 441202436268
• Email: hgemmell[@]aecc.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes

Intervention

Procedure:
• Specific massage for fascial release
Patient will receive a 3 minute massage to reduce restrictions in the lumbodorsal fascia.

Other:
• Quiet non-instructed rest for 3 minutes
Patient will lay quietly without any instructions on how to relax.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anglo-European College of Chiropractic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thickness of lumbodorsal fascia determined by ultrasound imaging		An average of 5 minutes from the the end of first treatment	No