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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Structured Rehabilitation | Experimental | Patients will begin Therapist-Guided Rehabilitation at 7 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks. |
|
| Delayed Rehabilitation | Experimental | Patients will begin Therapist-Guided Rehabilitation at 13 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks. |
|
| Self Rehabilitation | Active Comparator | Patients will begin Self-Guided Rehabilitation at 7 weeks postoperatively in a self-guided fashion. They will be provided with instructions for recommended exercises. They will undergo rehabilitation for a total of 10 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapist-Guided Rehabilitation | Other | Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Oswestry Disability Index [ODI] Score at 2-years | Oswestry Disability Index | Baseline, 2-year postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic fusion | Radiographic fusion at L4-5 levels as measured by computed tomography scan | Baseline, 1-year postoperative |
| Change from baseline in walking ability at 2-years | Walking test performed for 6 minutes |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Frank M Phillips, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carla Edwards | Evanston | Illinois | 60201 | United States |
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| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| Self-Guided Rehabilitation | Other | Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises. |
|
| Baseline, 2 years postoperative |
| Change from baseline in walking speed at 2-years | Walking test performed for 6 minutes | Baseline, 2 years postoperative |
| Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years | Visual Analogue Scale | Baseline, 2 year postoperative |
| Change from baseline in Short-Form 12 [SF-12] Scores at 2-years | Short-Form 12 | Baseline, 2 year postoperative |
| Change from baseline PROMIS Physical Function Scores at 2-years | PROMIS Physical Function | Baseline, 2 year postoperative |
| Change from baseline in Fear Avoidance Beliefs Metric at 2-years | Fear Avoidance Beliefs Questionnaire | Baseline, 2 year postoperative |
| Change from baseline in Pain Catastrophization Metric at 2-years | Pain Catastrophization Questionnaire | Baseline, 2 year postoperative |
| Change from baseline in Pain Neurophysiology Metric at 2-years | Pain Neurophysiology Questionnaire | Baseline, 2 year postoperative |