Single-Level TLIF: Post-Fusion Rehabilitation

Not Applicable

Completed

• Conditions: Degenerative Spinal Cord Disease
• Interventions: Other: Therapist-Guided Rehabilitation; Other: Self-Guided Rehabilitation

• Registration Number: NCT03033212
• Lead Sponsor: Rush University Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Study Start: 2017-08-21
• Status Verified: 2021-09
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Rehabilitation	Therapist-Guided 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.
Self Rehabilitation	Self-Guided 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.
Early Structured Rehabilitation	Therapist-Guided 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Carla Edwards; 🇺🇸 Evanston, Illinois, United States