An interventional study of Therapist-Guided Rehabilitation and Self-Guided Rehabilitation in Degenerative Spinal Cord Disease, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment
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.
200 studies on the registry are indexed under Spinal Cord Diseases; 51 are open to participants now.
This study's enrollment of 66 is above the median of 40 across 137 interventional studies indexed under Spinal Cord Diseases.
Browse Spinal Cord Diseases studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
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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
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
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
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 exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
Change from baseline in Oswestry Disability Index [ODI] Score at 2-years
Oswestry Disability Index
Time frame: Baseline, 2-year postoperative
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
Change from baseline in Pain Catastrophization Metric at 2-years
Pain Catastrophization Questionnaire
Time frame: Baseline, 2 year postoperative
Change from baseline in Pain Neurophysiology Metric at 2-years
Pain Neurophysiology Questionnaire
Time frame: Baseline, 2 year postoperative
Plan to share: Undecided
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Rush University Medical Center