Single-Level TLIF: Post-Fusion Rehabilitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Single-Level TLIF: Post-Fusion Rehabilitation

Conditions
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Degenerative Spinal Cord Disease

Intervention / Treatment
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* Other: Therapist-Guided Rehabilitation
* Other: Self-Guided Rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Structured Rehabilitation<br>Patients will begin Therapist-Guided Rehabilitation at 7 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks. | Other: Therapist-Guided Rehabilitation<br>* Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.<br>|
| Experimental: Delayed Rehabilitation<br>Patients will begin Therapist-Guided Rehabilitation at 13 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks. | Other: Therapist-Guided Rehabilitation<br>* Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.<br>|
| Active Comparator: Self Rehabilitation<br>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. | Other: Self-Guided Rehabilitation<br>* Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Oswestry Disability Index [ODI] Score at 2-years | Oswestry Disability Index | Baseline, 2-year postoperative | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |