Massage of the Low Back Muscles Assessed With Ultrasound Scanning
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
1 other identifier
interventional
70
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2010
CompletedFirst Posted
Study publicly available on registry
August 4, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 4, 2010
July 1, 2010
9 months
August 2, 2010
August 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Thickness of lumbodorsal fascia determined by ultrasound imaging
An average of 5 minutes from the the end of first treatment
Study Arms (2)
Fascial massage
EXPERIMENTALA specific type of fascial massage to release restricted lumbodorsal fascia.
No treatment control
NO INTERVENTIONPatient will rest quietly without receiving any instruction.
Interventions
Patient will receive a 3 minute massage to reduce restrictions in the lumbodorsal fascia.
Patient will lay quietly without any instructions on how to relax.
Eligibility Criteria
You may qualify if:
- History of chronic low back pain far at least 3 months
- Able to read and write English
- Between 18-64 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugh Gemmell, DC, EdD
Anglo-European College of Chiropractic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2010
First Posted
August 4, 2010
Study Start
September 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 4, 2010
Record last verified: 2010-07