N/A
N=102
Mechanisms of Specific Trunk Exercises in Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01362049 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in Oswestry Disability Scale (0-100%) — -8.26; -7.75; -8.00; -9.48 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Therapy rehabilitation: Stabilization exercises. (Other); Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Oswestry Disability Scale (0-100%) |
-8.8; -14.2; -10.1; -9.7 | — |
| PRIMARY Change From Baseline in Oswestry Disability Scale (0-100%) |
-8.8; -14.2; -10.1; -9.7 | — |
| PRIMARY Change From Baseline in Numeric Pain Rating Scale (0-10 Points) |
.18; -1.56; -1.35; -1.25 | — |
| PRIMARY Change From Baseline in Numeric Pain Rating Scale (0-10 Points) |
.18; -1.56; -1.35; -1.25 | — |
| SECONDARY Change From Baseline in SF-36 Health Survey (0 - 100 Points) |
4.40; 3.99; 3.34; 1.32 | — |
| SECONDARY Change From Baseline in SF-36 Health Survey (0-100 Points) |
3.16; 5.68; 2.72; 2.97 | — |
| SECONDARY Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points) |
-3.1; 0.6; -2.9; -1.6 | — |
| SECONDARY Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points) |
-3.1; 0.6; -2.9; -1.6 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01362049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.