Single-Level TLIF: Post-Fusion Rehabilitation

Rush University Medical Center66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Degenerative Spinal Cord Disease

Interventions

Therapist-Guided RehabilitationOTHER

Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.

Self-Guided RehabilitationOTHER

Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Carla Edwards

Evanston, Illinois, United States

Outcomes

Primary Outcomes

Change from baseline in Oswestry Disability Index [ODI] Score at 2-years

Oswestry Disability Index

Time frame: Baseline, 2-year postoperative

Secondary Outcomes

Radiographic fusion

Radiographic fusion at L4-5 levels as measured by computed tomography scan

Time frame: Baseline, 1-year postoperative

Change from baseline in walking ability at 2-years

Walking test performed for 6 minutes

Time frame: Baseline, 2 years postoperative

Change from baseline in walking speed at 2-years

Walking test performed for 6 minutes

Time frame: Baseline, 2 years postoperative

Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years

Visual Analogue Scale

Time frame: Baseline, 2 year postoperative

Change from baseline in Short-Form 12 [SF-12] Scores at 2-years

Short-Form 12

Time frame: Baseline, 2 year postoperative

Change from baseline PROMIS Physical Function Scores at 2-years

PROMIS Physical Function

Time frame: Baseline, 2 year postoperative

Change from baseline in Fear Avoidance Beliefs Metric at 2-years

Fear Avoidance Beliefs Questionnaire

Time frame: Baseline, 2 year postoperative

Data from ClinicalTrials.gov

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