An interventional study of Lumbar back brace and Back school in Degenerative Disc Disease, Lumbar Spondylosis and Low Back Pain, sponsored by Dallas VA Medical Center. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-01-08.
Sponsored by Dallas VA Medical Center · Not applicable, Interventional, and Treatment
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The main objectives of this study are to evaluate the benefits of back bracing in the symptomatic management of patients with CLBP due to degenerative lumbar disc disease. The plan is to study patients with uncomplicated CLBP without symptoms of radiculopathy or neurogenic claudication.
The secondary objectives of the study are to evaluate if a back brace provides any additive benefit to usual care consisting of exercise and patient education in patients with CLBP due to degenerative disc disease.
Specific Aim 1. To evaluate the effectiveness of back brace to improve pain and patient-reported functional measures in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy.
Hypothesis 1. Back brace in addition to usual care will provide statistically significant improvement in pain and functional measures compared to usual care alone.
Specific Aim 2. To evaluate the adherence to back brace wear instructions in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy Hypothesis 2. Patients with CLBP, due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy, who are prescribed a back brace, will demonstrate clinically acceptable rates of adherence to brace wear instructions.
Physiatrists use back braces (lumbar support, back corset, semi-rigid brace, and lumbar orthotic) for symptomatic management of patients' chronic low back pain (CLBP) despite very poor evidence supporting their use in the few published studies that have examined them. Evidence supporting back braces in other populations, such as pregnant women, and patients with sub-acute or acute low back pain, is better established. However, the benefits of back braces in the CLBP population are very unclear.
A Cochrane review on the role of lumbar supports in treating chronic LBP revealed that limited evidence was available, which led to the conclusion that, "it remains unclear whether lumbar supports are more effective than no or other interventions for treating low-back pain." The research emphasized the need for high quality randomized trials evaluating the effectiveness of back braces, and also recommended that compliance of brace wear be monitored.
The mechanism by which back braces might help patients with CLBP is also unclear. The semi-rigid design of the commonly used back brace does not mechanically limit movement enough to suggest that movement limitation is the mechanism by which back braces provide relief. However, some studies have suggested that back braces help patients with CLBP by providing postural support or a kinesthetic reminder of their posture. Using posturography, Munoz et al., studied the forces applied by lumbar bracing and concluded that back braces seem to help by improving the quality of balance strategy used by the patient. Another mechanism by which back braces are believed to help patients is by providing warmth underneath the brace.
There is poor published information regarding adherence to instructions (compliance) about the use of back braces. Based on the investigators' anecdotal clinical experience, adherence rates vary widely among patients who are prescribed back braces, ranging from non-use to constant use around the clock. Poor adherence to instructions can be a significant factor resulting in inconclusive evidence supporting the role of back brace in patients with CLBP. A recent study showed that a strong predictor for consistent adherence to back brace usage was a positive attitude towards it. In this study, positive attitude towards the back brace explained 41% of the variance in outcomes. In addition, investigators found that perceived benefit from the brace outweighed any subjective discomfort.
Back braces have been used as adjunctive therapy in addition to other conservative care options. A recent study evaluated the cumulative effect of bracing to exercise and found that bracing helps to increase trunk stiffness and augments muscle contractions, which may remind the patients to better comply with exercise instructions. This suggested a potential synergistic effect of bracing and exercise in the management of patients with CLBP.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's enrollment of 61 is close to the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Dallas VA Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.
Behavioral: Back school
Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.
Other: Lumbar back brace · Behavioral: Back school
A brace that supports the lumbar region of the spine.
Back school consists of patient education physical therapy exercise instruction.
Pain Diary
Patients rate their weekly pain on a scale from 0-10. Lower values indicate better outcomes. Average weekly pain scores were compared from baseline to 6 week mark.
Time frame: Change between baseline and each week for 6 weeks
Pain Disability Questionnaire
Measures how pain affects the patients lifestyle and participation in activities. Ranges from 0-150. Higher values indicate worse outcome.
Time frame: These assessments were made at baseline (T₀), 6 wks (T₁), 12 wks (T₂), and 6 mos (T₃). Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months).
PROMIS Instrument Questionnaire
Patient reported outcome measure that measures how their pain problem is interfering with their quality of life and function. Higher scores indicate worse outcomes. Higher scores = more pain interference with function, range = 0-112
Time frame: Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)
European Qualify of Life (EQ-5D) Questionnaire
Measures quality of life for pre- and post comparisons. Higher scores indicate better outcomes. higher scores = poorer quality of life, range = 0-10
Time frame: Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)
Participants with a diagnosis of lumbar degenerative disc disease or joint disease were recruited from the Physical Medicine and Rehabilitation clinic at the Veterans Affairs Medical Center, and were included in the study if they met the study criteria.
| Milestone | Control Group | Treatment Group |
|---|---|---|
| Started | 34 | 25 |
| Completed | 28 | 21 |
| Not completed | 6 | 4 |
| Withdrew: Withdrawal by subject | 6 | 4 |
Patients rate their weekly pain on a scale from 0-10. Lower values indicate better outcomes. Average weekly pain scores were compared from baseline to 6 week mark.
| units on a scale | Control Group | Treatment Group |
|---|---|---|
| Pain Diary | 6.71 ± 1.56 | 5 ± 1.78 |
Measures how pain affects the patients lifestyle and participation in activities. Ranges from 0-150. Higher values indicate worse outcome.
| units on a scale | Control Group | Treatment Group |
|---|---|---|
| Baseline | 79.26 ± 23.29 | 80.65 ± 23.33 |
| 6-weeks | 73 ± 24 | 78.2 ± 24 |
| 12-weeks | 68 ± 24 | 79.2 ± 25 |
| 6-months | 59.6 ± 25 | 80 ± 25.1 |
Patient reported outcome measure that measures how their pain problem is interfering with their quality of life and function. Higher scores indicate worse outcomes. Higher scores = more pain interference with function, range = 0-112
| units on a scale | Control Group | Treatment Group |
|---|---|---|
| Baseline | 53.82 ± 20.74 | 52.7 ± 18.37 |
| 6-weeks | 49 ± 21 | 53 ± 19 |
| 12-weeks | 47 ± 21.2 | 56 ± 22 |
| 6-months | 42.2 ± 22.2 | 61.9 ± 24 |
Measures quality of life for pre- and post comparisons. Higher scores indicate better outcomes. higher scores = poorer quality of life, range = 0-10
| units on a scale | Control Group | Treatment Group |
|---|---|---|
| Baseline | 3.82 ± 1.6 | 4.13 ± 1.75 |
| 6-weeks | 3.6 ± 1.5 | 4.3 ± 1.8 |
| 12-weeks | 3.4 ± 1.7 | 4.8 ± 1.9 |
| 6-months | 3 ± 1.5 | 5 ± 2.2 |
Collected over Adverse event data was collected till the final time point of the study (6 months from baseline visit). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Treatment Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Control Group | Treatment Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 21 | 51 |
| >=65 years | 4 | 4 | 8 |
| Age, Continuous(years) | Control Group | Treatment Group | Total |
|---|---|---|---|
| Mean | 49.5 ± 13.1 | 47.6 ± 15.1 | 48.9 ± 14.2 |
| Sex: Female, Male(Participants) | Control Group | Treatment Group | Total |
|---|---|---|---|
| Female | 8 | 3 | 11 |
| Male | 26 | 22 | 48 |
| Race/Ethnicity, Customized(Participants) | Control Group | Treatment Group | Total |
|---|---|---|---|
| African American/Black | 17 | 16 | 33 |
| Caucasian/White | 12 | 8 | 20 |
| Hispanic or Latino | 5 | 1 | 6 |
| Region of Enrollment(participants) | Control Group | Treatment Group | Total |
|---|---|---|---|
| United States | 34 | 25 | 59 |
| Pain Disability Questionnaire(units on a scale) | Control Group | Treatment Group | Total |
|---|---|---|---|
| Mean | 79.26 ± 23.29 | 80.65 ± 23.33 | 79.96 ± 23.31 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2015 to primary completion in Sep 2019, 44 months.
Results were first posted in Jan 2024, 4 years 3 months after primary completion.
Of 40 non-industry interventional studies with no phase under Intervertebral Disc Degeneration, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 63. This study's 44 months is close to that.
Counting every sponsor, half of 85 studies reached it within 50 months; a quarter within 27 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →
Dallas VA Medical Center