Low Back PainNCT00883987
Osteopathic Treatment of Low Back Pain
An observational study of Low Back Pain, run by Mary Lynch at 1 site in Canada.
Trial summary
Eighty percent of Canadians experience low back pain (LBP) at some point in their life (Waddell, 1987), with a point prevalence of up to 30 percent (O'Sullivan, 2005; Waddell, 1987). Low back pain has severe economic ramifications. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Dec 2012
- Phase
- Observational
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with chronic mechanical low back pain (Chronic low back pain is defined as having "pain between the lower ribs and gluteal folds, with minimal radiation to the thigh and never below the knee, present for a minimum of seven weeks"
Who may be able to join
- between the age of 19 and 55 years old,
- able to walk without assistance and /or assistive devices at least 4.7 meters.
- have adequate hearing acuity to detect verbal instructions.
- have adequate visual acuity to walk safely in usual ambient lighting without holding onto objects.
- be able to speak and comprehend English,
- have sufficient cognitive ability to follow instructions, and to provide informed consent, as defined by a Mini Mental Status Examination score of greater than 23 out of 30, performed by the research coordinator.
Who cannot join
- have had neurological signs and symptoms, or complications such as tumor or infection.
- are active in a claim pertaining to a motor vehicle accident or work injury or under any litigation for their pain.
- have had previous osteopathic treatment in the last year.
- had more than one abdominal surgery, or spinal fracture, or structural deformity such as scoliosis or spondylolithesis (Hubley-Kozey, 2002)
- have severe cardiopulmonary disease as determined by a health questionnaire with symptoms such as shortness of breath or chest pain on mild exertion or at rest,
- history of severe neurological disorder that impairs balance and mobility eg stroke, Parkinson's disease, peripheral neuropathy
Show all 11Show fewer
- have pain that leads to severe discomfort with minimal movement,
- have significant musculoskeletal impairment e.g. arthritis that leads to severe discomfort with walking that could lead to an abnormal gait,
- have cognitive compromise impairing ability to care for oneself, and ability to provide informed consent,
- have dizziness while standing,
- have a history of falls in previous month that might make it unsafe to participate in a gait study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Project to Study the Effect of Four Osteopathic Treatments on Trunk Muscle Firing Patterns and Temporospatial Parameters of Gait in Persons With Chronic Low Back Pain
Eighty percent of Canadians experience low back pain (LBP) at some point in their life (Waddell, 1987), with a point prevalence of up to 30 percent (O'Sullivan, 2005; Waddell, 1987). Low back pain has severe economic ramifications. Most incidents of low back pain occur during the prime working years of life, with an estimated cost to the economy at $14,744 Canadian dollars per person per year (Health Canada, 1998). Indirect costs in the form of long-term disability were highest for disorders of arthritis and chronic back pain (Health Canada, 1998). It has been estimated that 12 percent of patients will experience disability within one year after their first episode of low back pain (Banner, 2006). Evidence based diagnosis and treatment is important for desirable outcomes.
The investigators predict that there will be changes in A) trunk muscle electromyographic patterns and in temporo-spatial gait patterns following osteopathic treatment.
Read the detailed description
Research has outlined trunk muscle activation patterns in patients with LBP are different from those who do not suffer from low back pain (Clarke-Davidson and Hubley-Kozey, 2005; Hodges, 1996 and 1997; McGill, 2001 and 2002). Osteopathic research has documented the effects of osteopathic manipulative therapy (OMT) on EMG activity in patients with low back pain (Beckman, Harrington, Dostert, et al., 1991; Ellestad, Nagle, Boesler, et al.,1988; Krpan, Harrington, Beckman, 1992; Steiner, Park, Guzels, 1991) however these studies were limited in design and methodology.
In a controlled trial which measured levels of cellular enzymes to monitor tissue damage during OMT, blood serum enzyme levels did not change as a result of manipulation. More important, EMG levels decreased. OMT did not damage tissue but changed motor neuron activity (Rowane, Horner, Warner, et al., 1989). Beckman, et al., (1991) observed a reduction in EMG activity following OMT in patients with low back pain and found increased skin blood flow as measured by laser doppler flow meter. Steiner et al. (1991), reveal reduction to muscle spasm as measured by EMG in patients with low back pain following OMT. A further study (Ellestad, et al., 1988) noted decreased EMG activity during motion in patients with chronic low back pain. Thus there is preliminary work providing support for reduced EMG activity following OMT within low back pain treatment groups. However there is a need for further research in this area.
We also want to determine the role of manual therapy (osteopathy) in the management of gait dysfunction in this patient population. Patients with LBP present with reduced gait speed, poor thoraco-pelvic coordination and increased erector spinae activity (Lamoth et al. 2002 and 2006), altered weight bearing (Ellen Lee et al., 2007) and reduced single leg stance balance in static conditions (Louto et al., 1998).
Reduced thoraco-pelvic coordination leads to muscular stabilizing effects, altered kinematics, trunk rigidity, and reduced walking velocity (Lamoth et al., 2002). Specific impairments of body structure and function can reduce gait speed in older adults (Kerrigan, Todd, Della Cruce, 1998). Osteopathic intervention targets movement impairments of body structure and should change gait speed in patients with chronic LBP. Mal-alignment contributes to pathology in the pelvis and lumbar spine which can lead to degenerative changes, instability and pain (Aebi, 2005; Gurney, 2002; Steinburg, Luger, Arbel, et al., 2003). The focus of osteopathy is to restore mobility and alignment throughout the whole kinetic chain (Kutchera and Kutchera, 1991; Seffinger, 2007).
Improvement in gait speed and joint motion is shown after mobilization exercises to the ankle and hip in the elderly (Christiansen, 2003). A kinetic relationship links the ankle and pelvis (Gurney, 2002; Khamis \& Yizhar, 2007; Pinto, Souza, Tede, et al., 2008). Cephalo-caudal (pelvis affects ankle), caudal-cephalo (ankle affects pelvis) and ipsilateral-contralateral (one leg affects the other via the pelvis) alignment and kinematic relationships occur when lower extremity joints are maintained in altered positions (Pinto, et al., 2008). Can movement dysfunction secondary to impaired mobility and mal-alignment contribute to pain and antalgic gait?
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Back Pain | Patients with chronic mechanical low back pain (Chronic low back pain is defined as having "pain between the lower ribs and gluteal folds, with minimal radiation to the thigh and never below the knee, present for a minimum of seven weeks") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two primary outcome measures will be used for this study. The GAITRite gait analysis system and surface electromyography (EMG) respectively.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Lynch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Lynch, Nova Scotia Health Authority
- Investigators
- Mary Lynch, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883987
- Sponsor's protocol ID
- CDHA-RS/2009-366
- Status last verified
- Mar 2014
- First submitted
- 16 Apr 2009
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Project to Study the Effect of Four Osteopathic Treatments on Trunk Muscle Firing Patterns and Temporospatial Parameters of Gait in Persons With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00883987
- Acronym / sponsor ID
- CDHA-RS/2009-366
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mary LynchUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 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.
Eighty percent of Canadians experience low back pain (LBP) at some point in their life (Waddell, 1987), with a point prevalence of up to 30 percent (O'Sullivan, 2005; Waddell, 1987). Low back pain has severe economic ramifications. Most incidents of low back pain occur during the prime working years of life, with an estimated cost to the economy at $14,744 Canadian dollars per person per year (Health Canada, 1998). Indirect costs in the form of long-term disability were highest for disorders of arthritis and chronic back pain (Health Canada, 1998). It has been estimated that 12 percent of patients will experience disability within one year after their first episode of low back pain (Banner, 2006). Evidence based diagnosis and treatment is important for desirable outcomes.
The investigators predict that there will be changes in A) trunk muscle electromyographic patterns and in temporo-spatial gait patterns following osteopathic treatment.
Detailed description
Research has outlined trunk muscle activation patterns in patients with LBP are different from those who do not suffer from low back pain (Clarke-Davidson and Hubley-Kozey, 2005; Hodges, 1996 and 1997; McGill, 2001 and 2002). Osteopathic research has documented the effects of osteopathic manipulative therapy (OMT) on EMG activity in patients with low back pain (Beckman, Harrington, Dostert, et al., 1991; Ellestad, Nagle, Boesler, et al.,1988; Krpan, Harrington, Beckman, 1992; Steiner, Park, Guzels, 1991) however these studies were limited in design and methodology.
In a controlled trial which measured levels of cellular enzymes to monitor tissue damage during OMT, blood serum enzyme levels did not change as a result of manipulation. More important, EMG levels decreased. OMT did not damage tissue but changed motor neuron activity (Rowane, Horner, Warner, et al., 1989). Beckman, et al., (1991) observed a reduction in EMG activity following OMT in patients with low back pain and found increased skin blood flow as measured by laser doppler flow meter. Steiner et al. (1991), reveal reduction to muscle spasm as measured by EMG in patients with low back pain following OMT. A further study (Ellestad, et al., 1988) noted decreased EMG activity during motion in patients with chronic low back pain. Thus there is preliminary work providing support for reduced EMG activity following OMT within low back pain treatment groups. However there is a need for further research in this area.
We also want to determine the role of manual therapy (osteopathy) in the management of gait dysfunction in this patient population. Patients with LBP present with reduced gait speed, poor thoraco-pelvic coordination and increased erector spinae activity (Lamoth et al. 2002 and 2006), altered weight bearing (Ellen Lee et al., 2007) and reduced single leg stance balance in static conditions (Louto et al., 1998).
Reduced thoraco-pelvic coordination leads to muscular stabilizing effects, altered kinematics, trunk rigidity, and reduced walking velocity (Lamoth et al., 2002). Specific impairments of body structure and function can reduce gait speed in older adults (Kerrigan, Todd, Della Cruce, 1998). Osteopathic intervention targets movement impairments of body structure and should change gait speed in patients with chronic LBP. Mal-alignment contributes to pathology in the pelvis and lumbar spine which can lead to degenerative changes, instability and pain (Aebi, 2005; Gurney, 2002; Steinburg, Luger, Arbel, et al., 2003). The focus of osteopathy is to restore mobility and alignment throughout the whole kinetic chain (Kutchera and Kutchera, 1991; Seffinger, 2007).
Improvement in gait speed and joint motion is shown after mobilization exercises to the ankle and hip in the elderly (Christiansen, 2003). A kinetic relationship links the ankle and pelvis (Gurney, 2002; Khamis \& Yizhar, 2007; Pinto, Souza, Tede, et al., 2008). Cephalo-caudal (pelvis affects ankle), caudal-cephalo (ankle affects pelvis) and ipsilateral-contralateral (one leg affects the other via the pelvis) alignment and kinematic relationships occur when lower extremity joints are maintained in altered positions (Pinto, et al., 2008). Can movement dysfunction secondary to impaired mobility and mal-alignment contribute to pain and antalgic gait?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Back Pain | – | –Patients with chronic mechanical low back pain (Chronic low back pain is defined as having "pain between the lower ribs and gluteal folds, with minimal radiation to the thigh and never below the knee, present for a minimum of seven weeks") |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with chronic mechanical low back pain (Chronic low back pain is defined as having "pain between the lower ribs and gluteal folds, with minimal radiation to the thigh and never below the knee, present for a minimum of seven weeks"
Key inclusion criteria (6 listed)
- between the age of 19 and 55 years old,
- able to walk without assistance and /or assistive devices at least 4.7 meters.
- have adequate hearing acuity to detect verbal instructions.
- have adequate visual acuity to walk safely in usual ambient lighting without holding onto objects.
- be able to speak and comprehend English,
Key exclusion criteria (11 listed)
- have had neurological signs and symptoms, or complications such as tumor or infection.
- are active in a claim pertaining to a motor vehicle accident or work injury or under any litigation for their pain.
- have had previous osteopathic treatment in the last year.
- had more than one abdominal surgery, or spinal fracture, or structural deformity such as scoliosis or spondylolithesis (Hubley-Kozey, 2002)
- have severe cardiopulmonary disease as determined by a health questionnaire with symptoms such as shortness of breath or chest pain on mild exertion or at rest,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Two primary outcome measures will be used for this study. The GAITRite gait analysis system and surface electromyography (EMG) respectively.
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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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
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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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.
Mary Lynch, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Mary Lynch at 1 site in Canada.
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 6 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: finished, as of the sponsor's last update on 7 Mar 2014. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two primary outcome measures will be used for this study. The GAITRite gait analysis system and surface electromyography (EMG) respectively. (time frame: 12 hours). 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 7 Mar 2014.