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Massage of the Low Back Muscles Assessed With Ultrasound Scanning

Primary Purpose

Myofascial Pain Syndrome

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Specific massage for fascial release
Quiet non-instructed rest for 3 minutes
Sponsored by
Anglo-European College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial pain, Trigger points

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Fascial massage

    No treatment control

    Arm Description

    A specific type of fascial massage to release restricted lumbodorsal fascia.

    Patient will rest quietly without receiving any instruction.

    Outcomes

    Primary Outcome Measures

    Thickness of lumbodorsal fascia determined by ultrasound imaging

    Secondary Outcome Measures

    Full Information

    First Posted
    August 2, 2010
    Last Updated
    August 3, 2010
    Sponsor
    Anglo-European College of Chiropractic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01174667
    Brief Title
    Massage of the Low Back Muscles Assessed With Ultrasound Scanning
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    June 2011 (Anticipated)
    Study Completion Date
    June 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Anglo-European College of Chiropractic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myofascial Pain Syndrome
    Keywords
    Myofascial pain, Trigger points

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fascial massage
    Arm Type
    Experimental
    Arm Description
    A specific type of fascial massage to release restricted lumbodorsal fascia.
    Arm Title
    No treatment control
    Arm Type
    No Intervention
    Arm Description
    Patient will rest quietly without receiving any instruction.
    Intervention Type
    Procedure
    Intervention Name(s)
    Specific massage for fascial release
    Other Intervention Name(s)
    Superficial fascial release
    Intervention Description
    Patient will receive a 3 minute massage to reduce restrictions in the lumbodorsal fascia.
    Intervention Type
    Other
    Intervention Name(s)
    Quiet non-instructed rest for 3 minutes
    Other Intervention Name(s)
    Uninstructed rest
    Intervention Description
    Patient will lay quietly without any instructions on how to relax.
    Primary Outcome Measure Information:
    Title
    Thickness of lumbodorsal fascia determined by ultrasound imaging
    Time Frame
    An average of 5 minutes from the the end of first treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hugh Gemmell, DC, EdD
    Phone
    441202436268
    Ext
    268
    Email
    hgemmell@aecc.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jane Cook, DC, MSc
    Phone
    441202436200
    Ext
    208
    Email
    janecook@aecc.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hugh Gemmell, DC, EdD
    Organizational Affiliation
    Anglo-European College of Chiropractic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Massage of the Low Back Muscles Assessed With Ultrasound Scanning

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