Single-Level TLIF: Post-Fusion Rehabilitation

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 Overview

• Status: Completed
• Conditions: Degenerative Spinal Cord Disease
• Intervention / Treatment: Other: Therapist-Guided Rehabilitation; Other: Self-Guided Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Carla Edwards

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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.	Other: Self-Guided Rehabilitation; Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Frank M Phillips, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases
• Other Study ID Numbers: MORPFR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No