Single-Level TLIF: Post-Fusion Rehabilitation

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: September 1, 2021

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

  • Other: Therapist-Guided Rehabilitation
    • Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
  • Other: Self-Guided Rehabilitation
    • Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.

Arms, Groups and Cohorts

  • Experimental: Early Structured Rehabilitation
    • Patients will begin Therapist-Guided Rehabilitation at 7 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.
  • Experimental: Delayed Rehabilitation
    • Patients will begin Therapist-Guided Rehabilitation at 13 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.
  • Active Comparator: Self Rehabilitation
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in Oswestry Disability Index [ODI] Score at 2-years
    • Time Frame: Baseline, 2-year postoperative
    • Oswestry Disability Index

Secondary Measures

  • Radiographic fusion
    • Time Frame: Baseline, 1-year postoperative
    • Radiographic fusion at L4-5 levels as measured by computed tomography scan
  • Change from baseline in walking ability at 2-years
    • Time Frame: Baseline, 2 years postoperative
    • Walking test performed for 6 minutes
  • Change from baseline in walking speed at 2-years
    • Time Frame: Baseline, 2 years postoperative
    • Walking test performed for 6 minutes
  • Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years
    • Time Frame: Baseline, 2 year postoperative
    • Visual Analogue Scale
  • Change from baseline in Short-Form 12 [SF-12] Scores at 2-years
    • Time Frame: Baseline, 2 year postoperative
    • Short-Form 12
  • Change from baseline PROMIS Physical Function Scores at 2-years
    • Time Frame: Baseline, 2 year postoperative
    • PROMIS Physical Function
  • Change from baseline in Fear Avoidance Beliefs Metric at 2-years
    • Time Frame: Baseline, 2 year postoperative
    • Fear Avoidance Beliefs Questionnaire
  • Change from baseline in Pain Catastrophization Metric at 2-years
    • Time Frame: Baseline, 2 year postoperative
    • Pain Catastrophization Questionnaire
  • Change from baseline in Pain Neurophysiology Metric at 2-years
    • Time Frame: Baseline, 2 year postoperative
    • Pain Neurophysiology Questionnaire

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rush University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carla Edwards, Clinical Research Manger – Rush University Medical Center
  • Overall Official(s)
    • Frank M Phillips, MD, Principal Investigator, Rush University Medical Center

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