Human Motion Analysis Lab
Burlington, Vermont, 05401, United States
NCT Number: NCT01362049
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.
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Notify Me21 year–55 year
All sexes
Interventional
Not applicable
Burlington, Vermont, 05401, United States
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:
Within in each study arm, subjects will be randomly assigned to 1 of 2 exercise protocols for a 6-week period:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Trunk stabilization exercises, Segmental stabilization exercises
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: Specific exercise, Sarhmann exercise approach, MSI exercises
Time frame: Baseline and 7 weeks
Disability; Sacle 0-100% Lower score is considered better/improved
Time frame: Baseline and 12 Months
Disability; Sacle 0-100% Lower score is considered better/improved
Time frame: Baseline and 7 weeks
Current Pain Scale 0-10 Lower score is better/improved
Time frame: Baseline and 12 months
Current Pain Scale 0-10 Lower score is better/improved
Time frame: Baseline and 7 weeks
Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
Time frame: Baseline and 12 months
Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
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
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
University of Vermont
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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