Back Pain, Kyphosis
Conditions
Brief summary
The objective of this study is to evaluate clinical effectiveness and the effect on quality of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic patients with moderate to severe back pain disability and to demonstrate the safety of the intervention through detailed reporting and analysis of adverse events.
Interventions
OTHERSummit 456 TLSO
Thoracolumbarsacral orthosis
Sponsors
Aspen Medical Products
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with moderate to complete disability (crippled) as defined by a score of 21% to 80% on the baseline evaluation of the Oswestry Back Pain Disability Questionnaire; * Patients diagnosed with kyphosis and have a Cobb angle of at least 55 degrees; * Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion criteria
* Patients under the age of 19; * Pregnant patients or patients who are considering future pregnancies; * Patients who were participating in any other investigational device or drug study or whose participation in a previous investigational study within 30 days of study entry may, in the opinion of the clinical investigator, impact analysis of this orthotic; * Patients who, in the clinical judgment of the investigator, are not suitable for this study; Patients who, in the investigators opinion, are mentally or legally incapacitated preventing informed consent or unable to read or understand written material; * Patients who are unable or unwilling to return to the study center for follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measured amount of opioid medication consumed in the intervention group versus control group | Baseline and weeks 2,3,4,8,12,16,20 and 24 |
Other
| Measure | Time frame |
|---|---|
| ODI scores between the intervention group versus control group | Weeks 8, 12, 16, 20 and 24 |
| SF-26v2 Survey scores in the intervention versus the control group | Baseline and weeks 4, 8, 12 and 24. |
| Cost and return on investment of the LSO intervention | 24 weeks |
| Number of adverse events associated with the LSO intervention | Baseline and weeks 2, 3, 4, 8, 12, 16, 20 and 24 |
Outcome results
None listed