Clinical trial NCT03033212: Single-Level TLIF: Post-Fusion Rehabilitation
Official title: Single-Level TLIF: Post-Fusion Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Spinal Cord Disease
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Oswestry Disability Index [ODI] Score at 2-years
timeFrame: Baseline, 2-year postoperative
Secondary outcomes:
measure: Radiographic fusion
timeFrame: Baseline, 1-year postoperative
measure: Change from baseline in walking ability at 2-years
timeFrame: Baseline, 2 years postoperative
measure: Change from baseline in walking speed at 2-years
timeFrame: Baseline, 2 years postoperative
measure: Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years
timeFrame: Baseline, 2 year postoperative
measure: Change from baseline in Short-Form 12 [SF-12] Scores at 2-years
timeFrame: Baseline, 2 year postoperative
measure: Change from baseline PROMIS Physical Function Scores at 2-years
timeFrame: Baseline, 2 year postoperative
measure: Change from baseline in Fear Avoidance Beliefs Metric at 2-years
timeFrame: Baseline, 2 year postoperative
measure: Change from baseline in Pain Catastrophization Metric at 2-years
timeFrame: Baseline, 2 year postoperative
measure: Change from baseline in Pain Neurophysiology Metric at 2-years
timeFrame: Baseline, 2 year postoperative
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Carla Edwards
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Frank M Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References: