The Effects of Short Arc Banding
Primary Purpose
Chronic Low Back Pain
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Short Arc Banding
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Chronic mechanical low back pain (LBP) with a duration of greater than six weeks, severity and location remaining the same
- No current radicular symptoms extending below the knee
- Logan College Faculty, staff, as well as patients from any of Logan Health Center's allied clinics
Exclusion Criteria:
- Current radicular symptoms extending below the knee
- A history of neurological disease,
- History of severe lumbar trauma or surgery
- Contraindications to lumbar manipulation
- Current use of muscle relaxants or analgesics
- Degenerative joint disease (DJD)
- Recent spinal manipulative therapy (within 2 weeks of start of trial)
- Current use of modalities (e-stim, vibration, etc) and other exercise
- Diabetes
- Heart, kidney thyroid disorders and chronic disease
- Female subjects who are pregnant or breast feeding
Sites / Locations
- Logan College of ChiropracticRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Short Arc Banding Group
Arm Description
Lumbar extension on the ATM II from back project. Rehabilitation exercise intervention.
Outcomes
Primary Outcome Measures
Diagnostic ultrasound
Secondary Outcome Measures
Revised Oswestery Low Back Disability Questionnaire
Quadruple Visual Analogue Scale
Full Information
NCT ID
NCT00885001
First Posted
April 17, 2009
Last Updated
April 20, 2009
Sponsor
Logan College of Chiropractic
1. Study Identification
Unique Protocol Identification Number
NCT00885001
Brief Title
The Effects of Short Arc Banding
Official Title
The Effects of Short Arc Banding: A Novel Exercise Intervention in Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Logan College of Chiropractic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The general purpose of this pilot study is to determine the effects of a novel exercise intervention (short arc banding (SAB)) on the cross sectional area of lumbar multifidus well as functional outcomes assessments in patients with chronic low back pain.
Detailed Description
Multifidus muscle is well known and documented to be a segmental spinal stabilizer and postural muscle. (Bajek, Bogduk) Previous studies have shown evidence that patients with low back pain (LBP) present with multifidus muscle atrophy. It has been documented that patients presenting with unilateral back pain demonstrate an ipsilateral state of reduced cross sectional area of lumbar multifidus (LM) at the segmental level of injury or pain.(Barker, Hides) Chronic LBP sufferers demonstrate a localized and segmentally specific decrease in cross sectional area of multifidus.(Hides) It has been theorized that multifidus muscle surrounding a chronically painful or degenerative segment is less able to stabilize the spine at that segment, predisposing chronic LBP patients to exacerbation due to the inability to cope with demands of day to day life. (Bajek)
Rehabilitative Ultrasound Imaging (RUSI) has been verified as accurate and reliable in determining cross sectional area of lumbar multifidus (Hides). The interrater and intrarater reliability of RUSI has been shown high utilizing a standardized protocol. (Hides) Measurement of LM contraction using RUSI has been shown a valid and useful measure to determine activation of LM as correlated with EMG. (Kiesel) RUSI has been correlated with MRI which is the gold standard for measuring CSA of LM. (Hides)
Type I muscle fibers are the predominant muscle fiber type in lumbar multifidus which has led researchers to pursue spinal stabilization exercises which focus on isometric contractions. These interventions stimulate mainly Type I muscle fibers because they do not use speed or loading parameters theorized necessary to stimulate Type II fibers. (Rissanen, Ng) Previous studies by Rantanen examined LM fiber type in post surgery low backs. Patients with good recovery (minimal to no symptoms 5 years after surgery) showed increased Type II muscle fiber type in relation to those with a poor recovery and Type I fibers increased. (Rantanen) Limited mobility might account for decrease in diameter in Type II fibers in patients undergoing lumbar surgeries.
Notably, Type I muscle fibers appear to increase in size in the presence of chronic LBP. This is probably due to chronic pain induced low tension muscle spasm. (Mattila, Rantanen) Stokes suggested that LM takes on an increasing role in spinal stability due to atrophy of other muscles, thus the increase in size of Type I fibers versus Type II.
To date, the effects of a short arc fast tapping exercise with band resistance or short arc banding (SAB) on the cross sectional area of multifidus has not been documented in the literature. Short arc banding is a novel exercise treatment and to our knowledge is the first study of this mode of exercise. Using a fast motion against band resistance we hope to reach threshold necessary to stimulate not only type I muscle fibers which predominate the LM, but also type II muscle fibers. From the literature, type II muscle fibers decrease in cross sectional area in the presence of a segmental spinal lesion such as lumbar disc herniation. Type II muscle fibers of multifidus aid the spine to respond to and stabilize a ballistic load. Since modern man is much more sedentary, lumbar spines are not loaded adequately to produce stimulation and maintain size of Type II muscle fibers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short Arc Banding Group
Arm Type
Experimental
Arm Description
Lumbar extension on the ATM II from back project. Rehabilitation exercise intervention.
Intervention Type
Procedure
Intervention Name(s)
Short Arc Banding
Intervention Description
Lumbar extension on the ATM II from back project. Rehabilitation exercise intervention.
Primary Outcome Measure Information:
Title
Diagnostic ultrasound
Time Frame
beginning of the trial, at the two week mark and the end of the trial
Secondary Outcome Measure Information:
Title
Revised Oswestery Low Back Disability Questionnaire
Time Frame
at the beginning and end of the trail
Title
Quadruple Visual Analogue Scale
Time Frame
Beginning and end of the trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic mechanical low back pain (LBP) with a duration of greater than six weeks, severity and location remaining the same
No current radicular symptoms extending below the knee
Logan College Faculty, staff, as well as patients from any of Logan Health Center's allied clinics
Exclusion Criteria:
Current radicular symptoms extending below the knee
A history of neurological disease,
History of severe lumbar trauma or surgery
Contraindications to lumbar manipulation
Current use of muscle relaxants or analgesics
Degenerative joint disease (DJD)
Recent spinal manipulative therapy (within 2 weeks of start of trial)
Current use of modalities (e-stim, vibration, etc) and other exercise
Diabetes
Heart, kidney thyroid disorders and chronic disease
Female subjects who are pregnant or breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Morrell, DC
Phone
(636) 227-2100
Ext
1812
Email
Adam.Morrell@logan.edu
Facility Information:
Facility Name
Logan College of Chiropractic
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
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The Effects of Short Arc Banding
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