Spinal Control During Functional Activities to Improve Low Back Pain Outcomes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/15/2018 |
| Start Date: | December 2013 |
| End Date: | March 2019 |
Exercise is one of the primary interventions used with people with chronic, mechanical low
back pain. It is unknown, however, which exercise is best for which person, which exercises a
person will adhere to and for how long, and the effect of adhering to a specific type of
exercise on how the person functions, particularly in the long run. The purpose of this study
is to examine if the short- and long-term effects are different between 1) commonly
prescribed strength and flexibility exercises for the trunk and limbs, and 2) individualized
practice in daily functional activities that are difficult or painful to perform. Adherence
to the different interventions, the relationship between adherence and outcomes,as well as
the effect of a booster intervention also will be examined.
back pain. It is unknown, however, which exercise is best for which person, which exercises a
person will adhere to and for how long, and the effect of adhering to a specific type of
exercise on how the person functions, particularly in the long run. The purpose of this study
is to examine if the short- and long-term effects are different between 1) commonly
prescribed strength and flexibility exercises for the trunk and limbs, and 2) individualized
practice in daily functional activities that are difficult or painful to perform. Adherence
to the different interventions, the relationship between adherence and outcomes,as well as
the effect of a booster intervention also will be examined.
For many people, mechanical low back pain (LBP) is a long-term, function-limiting condition
rather than a short-term, self-limiting condition. Exercise is one of the primary
non-surgical approaches used worldwide for managing LBP. Specifically in people with chronic
LBP, exercise has been found to be as efficacious, if not more efficacious than 1) no
treatment, 2) usual care, and 3) many other treatments, such as massage or laser therapy.
Despite the growing body of evidence for the beneficial effects of exercise, however, there
is limited evidence about 1) which exercise is best for which person, 2) how long the effects
of different exercises last, 3) which types of exercise people will adhere to, and for how
long, and 4) the mechanisms underlying the effects of different types of exercise.
This study aims to address these limitations by directly comparing the effects of 1) exercise
to increase strength of the trunk and increase flexibility of the trunk and extremities, and
2) individualized, motor skill training directed at performance of daily functional
activities that are painful or limited due to the person's LBP. This study also will examine
1) the effects of a booster phase of intervention, 2) the relationship between adherence to
intervention and function, and 3) the relationship between performance of functional
activities and function-related outcomes. People with chronic LBP will be randomized to 1) an
intervention of strength and flexibility exercise or motor skill training, and 2) a booster
or no-booster intervention. Intervention will be provided in 2 phases: 1) initial phase: 6 -
1 hour sessions, once/week for 6 weeks, and 2) booster phase: # of sessions needed to regain
independence in home program, beginning 6 months after the initial phase. The investigators
will collect 1) measurements of pain, function, disability, and economic outcomes, 2) reports
of adherence, and 3) laboratory-based measures of performance of functional activities.
People will be followed for 12 months after the initial intervention phase. Three sets of
hypotheses are proposed. First, the investigators hypothesize that both interventions will
result in improvements in pain, function, disability, and economic outcomes, but that the
motor skill training will result in more long lasting improvements than the strength and
flexibility exercise. Second, the investigators hypothesize that the effect of a booster
phase of intervention will 1) result in longer lasting improvement in function and better
adherence than a no-booster intervention, and 2) be greater for motor skill training than for
strength and flexibility exercise. Finally, the investigators hypothesize that 1) adherence
to motor skill training will be more strongly related to function than will adherence to
strength and flexibility exercise, and 2) performance of functional activities by people
receiving motor skill training will be more strongly related to function than performance of
functional activities by people receiving strength and flexibility exercise.
rather than a short-term, self-limiting condition. Exercise is one of the primary
non-surgical approaches used worldwide for managing LBP. Specifically in people with chronic
LBP, exercise has been found to be as efficacious, if not more efficacious than 1) no
treatment, 2) usual care, and 3) many other treatments, such as massage or laser therapy.
Despite the growing body of evidence for the beneficial effects of exercise, however, there
is limited evidence about 1) which exercise is best for which person, 2) how long the effects
of different exercises last, 3) which types of exercise people will adhere to, and for how
long, and 4) the mechanisms underlying the effects of different types of exercise.
This study aims to address these limitations by directly comparing the effects of 1) exercise
to increase strength of the trunk and increase flexibility of the trunk and extremities, and
2) individualized, motor skill training directed at performance of daily functional
activities that are painful or limited due to the person's LBP. This study also will examine
1) the effects of a booster phase of intervention, 2) the relationship between adherence to
intervention and function, and 3) the relationship between performance of functional
activities and function-related outcomes. People with chronic LBP will be randomized to 1) an
intervention of strength and flexibility exercise or motor skill training, and 2) a booster
or no-booster intervention. Intervention will be provided in 2 phases: 1) initial phase: 6 -
1 hour sessions, once/week for 6 weeks, and 2) booster phase: # of sessions needed to regain
independence in home program, beginning 6 months after the initial phase. The investigators
will collect 1) measurements of pain, function, disability, and economic outcomes, 2) reports
of adherence, and 3) laboratory-based measures of performance of functional activities.
People will be followed for 12 months after the initial intervention phase. Three sets of
hypotheses are proposed. First, the investigators hypothesize that both interventions will
result in improvements in pain, function, disability, and economic outcomes, but that the
motor skill training will result in more long lasting improvements than the strength and
flexibility exercise. Second, the investigators hypothesize that the effect of a booster
phase of intervention will 1) result in longer lasting improvement in function and better
adherence than a no-booster intervention, and 2) be greater for motor skill training than for
strength and flexibility exercise. Finally, the investigators hypothesize that 1) adherence
to motor skill training will be more strongly related to function than will adherence to
strength and flexibility exercise, and 2) performance of functional activities by people
receiving motor skill training will be more strongly related to function than performance of
functional activities by people receiving strength and flexibility exercise.
Inclusion Criteria:
- chronic low back pain for a minimum of 12 months
- currently experiencing low back pain symptoms but not in a recurrence or an acute
flare-up
- Modified Oswestry Disability Index score of ≥ 20%
- 3 or more functional activities limited due to low back pain
- able to stand and walk without assistance
- able to understand and sign a consent form
Exclusion Criteria:
- any structural spinal deformity including scoliosis, kyphosis, or stenosis
- spinal fracture or dislocation
- low back pain due to trauma
- osteoporosis
- ankylosing spondylitis
- rheumatoid arthritis
- fibromyalgia
- symptomatic disc herniation
- spondylolisthesis
- serious spinal complications such as tumor or infection
- previous spinal surgery
- frank neurological loss, i.e., weakness and sensory loss
- pain or paresthesia below the knee
- etiology of low back pain other than the lumbar spine, e.g., hip joint
- history of neurologic disease which required hospitalization
- active treatment for cancer
- history of unresolved cancer
- pregnancy
- worker's compensation, disability, or litigation case
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Linda R Van Dillen, P.T., Ph.D.
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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