Mechanisms of Specific Trunk Exercises in Low Back Pain
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| ClinicalTrials.gov Identifier: NCT01362049 |
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Recruitment Status :
Completed
First Posted : May 27, 2011
Results First Posted : April 4, 2017
Last Update Posted : June 5, 2017
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Sponsor:
University of Vermont
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sharon M. Henry, University of Vermont
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Brief Summary:
The research objective is to determine which physical therapy (PT) treatment is the most efficacious for patients with lower back pain (LBP), who have been subgrouped based on certain clinical features. There is only limited evidence that supports any one PT treatment for patients with LBP since PT treatment outcomes for exercise protocols are equivocal, given the heterogeneous clinical features of patients with LBP. Thus, classification of patients with LBP into subgroups with shared clinical features has been identified as a research priority by several groups in order to prescribe the most efficacious PT treatment for each homogeneous subgroup. The investigators hypothesize that particular PT treatments are most efficacious when applied to patients with LBP, who present with particular clinical and neuromuscular features.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Low Back Pain | Other: Physical Therapy rehabilitation: Stabilization exercises. Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise | Not Applicable |
The proposed studies focus on 2 schemas to classify LBP: 1) the Treatment-Based Classification (TBC) system, from which clinical prediction rules about who is most likely to benefit from spinal stabilization exercises (among others) have been developed, and 2) the Movement System Impairment-Based Classification (MSI) system, which includes 5 classifications of LBP named for the specific direction(s) of movements and alignments associated with the person's LBP.
The primary purpose of this proposal is to conduct a prospective, randomized, controlled Phase II clinical trial in order to examine whether or not treatment matched to a patient's specific signs and symptoms (patient-matched) per the TBC is more effective than the MSI system for improving short- (6 weeks) and long-term (12 and 24 months) outcomes in people with chronic LBP. A secondary purpose is to identify prognostic factors that predict clinical outcomes in the 2 treatment groups being compared.
Subjects will be assigned to one of two study arms:
- eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria ('Eligible' Subject Group); and
- subjects who are not eligible for the TBC-based stabilization exercises ('Ineligible' Subject Group).
Within in each study arm, subjects will be randomly assigned to 1 of 2 exercise protocols for a 6-week period:
- stabilization - a protocol focused on improving the motor control of trunk muscles to stabilize the spine; or
- MSI-based - a classification-specific treatment focused on education and instruction for modifying movement strategies during functional activities, and on exercises specific to the classification category.
Laboratory measures (muscle activation, kinematics, forces) during standardized tasks will quantify neuromuscular impairments associated with LBP and clinical questionnaires will quantify changes in pain, function, and health status pre- and post-treatment. The addition of neuromuscular measures to these classification schemas could improve the sensitivity and specificity of each.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Mechanisms of Specific Trunk Exercises in Low Back Pain |
| Study Start Date : | March 2010 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | December 2013 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 'Eligible' Subject Group - STAB
Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
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Other: Physical Therapy rehabilitation: Stabilization exercises.
The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Other Names:
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Active Comparator: 'Ineligible' Subject Group - STAB
Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
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Other: Physical Therapy rehabilitation: Stabilization exercises.
The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Other Names:
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Active Comparator: 'Eligible' Subject Group - MSI
Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
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Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
The MSI-classification based approach focuses on education and instruction for modifying movement strategies during functional activities, and on exercises that are specific to the classification category. First there is an analysis of and instruction in modifying a subject's direction-specific alignment and movement strategies during symptomatic functional activities. Second, there is education about the principles of tissue injury and healing, and how cumulative tissue stress contributes to microtrauma and LBP. Unique to the education process is the emphasis on how using one's particular movement strategies during functional activities may accelerate tissue stress accumulation because the strategies are used repetitively. Thirdly, there is exercise prescription that includes practice in performing modified versions of the direction-specific impairment tests from the physical exam, with an emphasis on impairments that can be modified to eliminate LBP symptoms.
Other Names:
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Active Comparator: 'Ineligible' Subject Group -MSI
Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
|
Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
The MSI-classification based approach focuses on education and instruction for modifying movement strategies during functional activities, and on exercises that are specific to the classification category. First there is an analysis of and instruction in modifying a subject's direction-specific alignment and movement strategies during symptomatic functional activities. Second, there is education about the principles of tissue injury and healing, and how cumulative tissue stress contributes to microtrauma and LBP. Unique to the education process is the emphasis on how using one's particular movement strategies during functional activities may accelerate tissue stress accumulation because the strategies are used repetitively. Thirdly, there is exercise prescription that includes practice in performing modified versions of the direction-specific impairment tests from the physical exam, with an emphasis on impairments that can be modified to eliminate LBP symptoms.
Other Names:
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Primary Outcome Measures :
- Change From Baseline in Oswestry Disability Scale (0-100%) [ Time Frame: Baseline and 7 weeks ]Disability; Sacle 0-100% Lower score is considered better/improved
- Change From Baseline in Oswestry Disability Scale (0-100%) [ Time Frame: Baseline and 12 Months ]Disability; Sacle 0-100% Lower score is considered better/improved
- Change From Baseline in Numeric Pain Rating Scale (0-10 Points) [ Time Frame: Baseline and 7 weeks ]Current Pain Scale 0-10 Lower score is better/improved
- Change From Baseline in Numeric Pain Rating Scale (0-10 Points) [ Time Frame: Baseline and 12 months ]Current Pain Scale 0-10 Lower score is better/improved
Secondary Outcome Measures :
- Change From Baseline in SF-36 Health Survey (0 - 100 Points) [ Time Frame: Baseline and 7 weeks ]Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
- Change From Baseline in SF-36 Health Survey (0-100 Points) [ Time Frame: Baseline and 12 months ]Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
- Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points) [ Time Frame: Baseline and 7 weeks ]fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty
- Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points) [ Time Frame: Baseline and 12 months ]fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- a history of chronic LBP with or without recurrences for a minimum of 12 months;
- between 21 - 55 years of age;
- able to stand and walk without assistance;
- have an Oswestry Disability Score of 19% or higher AND/OR less than an 8 on one activity reported on the Patient Specific Functional Scale,
Exclusion Criteria:
- any major structural spinal deformity including scoliosis, kyphosis, or stenosis;
- spinal fracture or dislocation;
- osteoporosis;
- ankylosing spondylitis;
- rheumatoid arthritis;
- disc herniation with corroborating clinical signs and symptoms;
- 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 LBP other than the lumbar spine, e.g., hip joint;
- history of neurological disease which required hospitalization;
- active treatment for cancer;
- history of unresolved cancer;
- pregnancy or less than 6 months post-partum or less than 6 months post weaning;
- magnified symptom-behavior;
- worker's compensation or disability case;
- in litigation for the LBP problem;
- have a BMI ≥ 30.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362049
Locations
| United States, Vermont | |
| Human Motion Analysis Lab | |
| Burlington, Vermont, United States, 05401 | |
Sponsors and Collaborators
University of Vermont
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Sharon M Henry, PT, PhD | University of Vermont |
Publications of Results:
Other Publications:
Other Publications:
| Responsible Party: | Sharon M. Henry, Professor, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT01362049 |
| Other Study ID Numbers: |
CHRMS 10-045 5R01HD040909-07 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 27, 2011 Key Record Dates |
| Results First Posted: | April 4, 2017 |
| Last Update Posted: | June 5, 2017 |
| Last Verified: | May 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Sharon M. Henry, University of Vermont:
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Stabilization exercise Physical therapy Rehabilitation Movement System Impairment exercise |
Additional relevant MeSH terms:
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Back Pain Low Back Pain Pain Neurologic Manifestations |