Degenerative Disc Disease, Lumbar Spondylosis, Low Back Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERLumbar back brace
A brace that supports the lumbar region of the spine.
BEHAVIORALBack school
Back school consists of patient education physical therapy exercise instruction.
Sponsors
Aspen Medical Products
Dallas VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, randomized controlled trial. Blinding of the subjects is not possible because a back brace is a visibly obvious intervention. In addition, since we are evaluating the adherence of back brace wear, blinding of the investigator is also not possible. Therefore, this study will be an unblinded RCT.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of lumbar degenerative disc disease or joint disease * Low back pain \> 6 weeks * Uncomplicated low back pain without symptoms of pain radiating below the knee
Exclusion criteria
* Lumbar radiculopathy * Neurogenic claudication * Spondylolisthesis with instability * Previous lumbar spine surgery * Recent (\<1 year) brace use or physical therapy program * No active psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Diary | Change between baseline and each week for 6 weeks | 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. |
| Pain Disability Questionnaire | 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). | Measures how pain affects the patients lifestyle and participation in activities. Ranges from 0-150. Higher values indicate worse outcome. |
| PROMIS Instrument Questionnaire | Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months) | 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 |
| European Qualify of Life (EQ-5D) Questionnaire | Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months) | Measures quality of life for pre- and post comparisons. Higher scores indicate better outcomes. higher scores = poorer quality of life, range = 0-10 |
Participant flow
Recruitment details
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.
Pre-assignment details
2 participants withdrew after enrollment
Participants by arm
| Arm | Count |
|---|---|
| Control Group 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.
Back school: Back school consists of patient education physical therapy exercise instruction. | 34 |
| Treatment Group 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.
Lumbar back brace: A brace that supports the lumbar region of the spine.
Back school: Back school consists of patient education physical therapy exercise instruction. | 25 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 6 | 4 |
Baseline characteristics
| Characteristic | Control Group | Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 21 Participants | 51 Participants |
| Age, Continuous | 49.5 years STANDARD_DEVIATION 13.1 | 47.6 years STANDARD_DEVIATION 15.1 | 48.9 years STANDARD_DEVIATION 14.2 |
| Pain Disability Questionnaire | 79.26 units on a scale STANDARD_DEVIATION 23.29 | 80.65 units on a scale STANDARD_DEVIATION 23.33 | 79.96 units on a scale STANDARD_DEVIATION 23.31 |
| Race/Ethnicity, Customized African American/Black | 17 Participants | 16 Participants | 33 Participants |
| Race/Ethnicity, Customized Caucasian/White | 12 Participants | 8 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Region of Enrollment United States | 34 participants | 25 participants | 59 participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 26 Participants | 22 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 25 |
| other Total, other adverse events | 0 / 34 | 0 / 25 |
| serious Total, serious adverse events | 0 / 34 | 0 / 25 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | European Qualify of Life (EQ-5D) Questionnaire | Baseline | 3.82 units on a scale | Standard Deviation 1.6 |
| Control Group | European Qualify of Life (EQ-5D) Questionnaire | 6-weeks | 3.6 units on a scale | Standard Deviation 1.5 |
| Control Group | European Qualify of Life (EQ-5D) Questionnaire | 12-weeks | 3.4 units on a scale | Standard Deviation 1.7 |
| Control Group | European Qualify of Life (EQ-5D) Questionnaire | 6-months | 3 units on a scale | Standard Deviation 1.5 |
| Treatment Group | European Qualify of Life (EQ-5D) Questionnaire | 6-months | 5 units on a scale | Standard Deviation 2.2 |
| Treatment Group | European Qualify of Life (EQ-5D) Questionnaire | Baseline | 4.13 units on a scale | Standard Deviation 1.75 |
| Treatment Group | European Qualify of Life (EQ-5D) Questionnaire | 12-weeks | 4.8 units on a scale | Standard Deviation 1.9 |
| Treatment Group | European Qualify of Life (EQ-5D) Questionnaire | 6-weeks | 4.3 units on a scale | Standard Deviation 1.8 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Pain Diary | 6.71 units on a scale | Standard Deviation 1.56 |
| Treatment Group | Pain Diary | 5 units on a scale | Standard Deviation 1.78 |
Primary
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Pain Disability Questionnaire | Baseline | 79.26 units on a scale | Standard Deviation 23.29 |
| Control Group | Pain Disability Questionnaire | 6-weeks | 73 units on a scale | Standard Deviation 24 |
| Control Group | Pain Disability Questionnaire | 12-weeks | 68 units on a scale | Standard Deviation 24 |
| Control Group | Pain Disability Questionnaire | 6-months | 59.6 units on a scale | Standard Deviation 25 |
| Treatment Group | Pain Disability Questionnaire | 6-months | 80 units on a scale | Standard Deviation 25.1 |
| Treatment Group | Pain Disability Questionnaire | Baseline | 80.65 units on a scale | Standard Deviation 23.33 |
| Treatment Group | Pain Disability Questionnaire | 12-weeks | 79.2 units on a scale | Standard Deviation 25 |
| Treatment Group | Pain Disability Questionnaire | 6-weeks | 78.2 units on a scale | Standard Deviation 24 |
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | PROMIS Instrument Questionnaire | Baseline | 53.82 units on a scale | Standard Deviation 20.74 |
| Control Group | PROMIS Instrument Questionnaire | 6-weeks | 49 units on a scale | Standard Deviation 21 |
| Control Group | PROMIS Instrument Questionnaire | 12-weeks | 47 units on a scale | Standard Deviation 21.2 |
| Control Group | PROMIS Instrument Questionnaire | 6-months | 42.2 units on a scale | Standard Deviation 22.2 |
| Treatment Group | PROMIS Instrument Questionnaire | 6-months | 61.9 units on a scale | Standard Deviation 24 |
| Treatment Group | PROMIS Instrument Questionnaire | Baseline | 52.7 units on a scale | Standard Deviation 18.37 |
| Treatment Group | PROMIS Instrument Questionnaire | 12-weeks | 56 units on a scale | Standard Deviation 22 |
| Treatment Group | PROMIS Instrument Questionnaire | 6-weeks | 53 units on a scale | Standard Deviation 19 |