N/A
N=154
Spinal Control During Functional Activities to Improve Low Back Pain Outcomes
Mechanical Low Back Pain · Chronic Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02027623 ↗Enrolled (actual)
154
Serious AEs
1.3%
Results posted
Jul 2019
Primary outcome: Primary: Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase — 32.3; 32.6; 12.8; 21.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motor skill training (Behavioral); Strength and flexibility exercise (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase |
32.3; 32.6; 12.8; 21.2 | — |
| PRIMARY Change in Modified Oswestry Disability Questionnaire (0-100%) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase |
12.8; 21.2; 12.0; 18.2 | — |
| PRIMARY Change in Modified Oswestry Disability Questionnaire (0-100%) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase |
12.0; 18.2; 10.8; 16.7 | — |
| SECONDARY Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase |
4.7; 4.7; 1.4; 2.1; 6.3; 6.9 | — |
| SECONDARY Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase |
1.4; 2.1; 2.0; 2.6; 2.7; 4.0 | — |
| SECONDARY Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase |
2.0; 2.6; 1.8; 2.6; 2.9; 3.8 | — |
| SECONDARY Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From Baseline to 6 Months After Initial Intervention Phase |
7.1; 9.8; 2.0; 4.2 | — |
| SECONDARY Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From 6 Months After the Initial Intervention Phase to 12 Months After Initial Intervention Phase |
2.0; 4.2; 1.3; 2.0 | — |
| SECONDARY Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Baseline to Completion of Initial 6 Week Intervention Phase |
50; 47; 21; 31 | — |
| SECONDARY Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase |
21; 31; 27; 29 | — |
| SECONDARY Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From 6 Months After Completion of Initial Intervention Phase to 12 Months After Completion of Initial Intervention Phase |
27; 29; 23; 25 | — |
| SECONDARY Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Baseline to Completion of Initial 6 Week Intervention Phase |
42; 47; 11; 29 | — |
| SECONDARY Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase |
11; 29; 9; 11 | — |
| SECONDARY Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase |
9; 11; 11; 12 | — |
| SECONDARY Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Baseline to Completion of Initial 6 Week Intervention Phase |
20.3; 19.9; 17.4; 18.3 | — |
| SECONDARY Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase |
17.4; 18.3; 15.9; 16.5 | — |
| SECONDARY Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase |
15.9; 16.5; 15.4; 16.7 | — |
| SECONDARY Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase |
43.2; 40.8; 50.8; 46.3 | — |
| SECONDARY Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase |
50.8; 46.3; 50.9; 47.8 | — |
| SECONDARY Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase |
50.9; 47.8; 51.2; 48.3 | — |
| SECONDARY Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase |
49.2; 52.1; 50.7; 51.0 | — |
| SECONDARY Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase |
50.7; 51.0; 49.6; 50.8 | — |
| SECONDARY Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase |
49.6; 50.8; 50.4; 50.3 | — |
| SECONDARY Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Baseline to Completion of Initial 6 Week Intervention Phase |
35; 29; 7; 6; 66; 65 | — |
| SECONDARY Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase |
7; 6; 13; 13; 62; 48 | — |
| SECONDARY Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase |
13; 13; 8; 11; 33; 29 | — |
| SECONDARY Satisfaction With Care (15-75 Points) |
68.8; 61.4 | — |
| SECONDARY Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase |
11.32; 11.23; 9.17; 11.05; 21.17; 20.84 | — |
| SECONDARY Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase |
9.17; 11.05; 8.63; 10.84; 31.98; 20.36 | — |
Summary
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.
Eligibility Criteria
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
- BMI >30
- 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
- Graves' disease
- Marfan syndrome
- Unable to classify low back pain based on clinical examination findings
Data sourced from ClinicalTrials.gov (NCT02027623). 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.