Chronic Low Back PainPhase 1/2NCT00885001
The Effects of Short Arc Banding
A Phase 1/2 study testing Short Arc Banding in people with Chronic Low Back Pain, run by Logan College of Chiropractic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Short Arc Banding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Logan College of Chiropractic
Chesterfield, Missouri, 63017
About this study
Official title: The Effects of Short Arc Banding: A Novel Exercise Intervention in Patients With Chronic Low Back Pain
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.
Read the 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
- Conditions
- Chronic Low Back Pain
- Being tested
- Short Arc Banding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Arc BandingProcedure or surgery
Lumbar extension on the ATM II from back project. Rehabilitation exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| Short Arc Banding Group | Experimental | Lumbar extension on the ATM II from back project. Rehabilitation exercise intervention. Receives: Procedure: Short Arc Banding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic ultrasound
Measured: beginning of the trial, at the two week mark and the end of the trial
Secondary outcomes (2)
Revised Oswestery Low Back Disability Questionnaire
Measured: at the beginning and end of the trail
Quadruple Visual Analogue Scale
Measured: Beginning and end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885001
- Sponsor's protocol ID
- RD0311090179
- Other IDs
- 403
- Status last verified
- Apr 2009
- First submitted
- 17 Apr 2009
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short Arc Banding: A Novel Exercise Intervention in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00885001
- Acronym / sponsor ID
- RD0311090179
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short Arc Banding Group | Experimental | Procedure: Short Arc BandingLumbar extension on the ATM II from back project. Rehabilitation exercise intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Arc BandingLumbar extension on the ATM II from back project. Rehabilitation exercise intervention. | Procedure or surgery | Short Arc Banding Group |
Primary outcome
Diagnostic ultrasound
Time frame: beginning of the trial, at the two week mark and the end of the trial
2 secondary outcomes
Revised Oswestery Low Back Disability Questionnaire
Time frame: at the beginning and end of the trail
Quadruple Visual Analogue Scale
Time frame: Beginning and end of the trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2009.
Related trials for Chronic Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Short Arc Banding in people with Chronic Low Back Pain, run by Logan College of Chiropractic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Morrell, DC ((636) 227-2100 ext. 1812, Adam.Morrell@logan.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic ultrasound (time frame: beginning of the trial, at the two week mark and the end of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2009.