Degenerative Spinal Cord Disease
Conditions
Brief summary
This investigation will assess how the timing and type of rehabilitation after a transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure. The efficacy of the procedure will be evaluated through patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure. These measures will be compared to the patients' baseline value.
Detailed description
Patients will undergo transforaminal lumbar interbody fusion for degenerative pathology at the L4-5 vertebral level. They will be randomized to one of three postoperative rehabilitation groups. Group 1 will receive structured early rehabilitation beginning at 7 weeks. Group 2 will receive Delayed rehabilitation beginning at 13 weeks postoperatively. Group 3 will undergo Self Rehabilitation beginning at 7 weeks postoperatively. Groups 1 and 2 will undergo rehabilitation under the supervision of a certified physical therapist for 10 total weeks. Group 3 will undergo non-supervised rehabilitation for 10 total weeks, and will be given educational materials regarding which exercises to perform and at which intervals.
Interventions
OTHERTherapist-Guided Rehabilitation
Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
OTHERSelf-Guided Rehabilitation
Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
i. Single-level L4-L5 TLIF for degenerative pathology, including: radiculopathy, neurogenic claudication, intervertebral disc disease, facet joint disease, degenerative spondylolisthesis, degenerative myelopathy degenerative kyphosis and scoliosis ii. Back and/or leg pain iii. Failed at least 3 months of conservative treatment
Exclusion criteria
i. Older than 65 years of age ii. Prior spinal surgery excluding laminectomy/discectomy iii. Greater than Grade 2 spondylolisthesis iv. Greater than 10 degrees scoliosis v. Not worked for greater than 6 months or unemployed as a result of lumbar condition vi. History of spinal infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Oswestry Disability Index [ODI] Score at 2-years | Baseline, 2-year postoperative | Oswestry Disability Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in walking ability at 2-years | Baseline, 2 years postoperative | Walking test performed for 6 minutes |
| Change from baseline in walking speed at 2-years | Baseline, 2 years postoperative | Walking test performed for 6 minutes |
| Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years | Baseline, 2 year postoperative | Visual Analogue Scale |
| Change from baseline in Short-Form 12 [SF-12] Scores at 2-years | Baseline, 2 year postoperative | Short-Form 12 |
| Radiographic fusion | Baseline, 1-year postoperative | Radiographic fusion at L4-5 levels as measured by computed tomography scan |
| Change from baseline in Fear Avoidance Beliefs Metric at 2-years | Baseline, 2 year postoperative | Fear Avoidance Beliefs Questionnaire |
| Change from baseline in Pain Catastrophization Metric at 2-years | Baseline, 2 year postoperative | Pain Catastrophization Questionnaire |
| Change from baseline in Pain Neurophysiology Metric at 2-years | Baseline, 2 year postoperative | Pain Neurophysiology Questionnaire |
| Change from baseline PROMIS Physical Function Scores at 2-years | Baseline, 2 year postoperative | PROMIS Physical Function |
Countries
United States
Outcome results
None listed