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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03033212
Other study ID # MORPFR001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 21, 2017
Est. completion date September 1, 2021

Study information

Verified date September 2021
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
Self-Guided Rehabilitation
Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.

Locations

Country Name City State
United States Carla Edwards Evanston Illinois

Sponsors (1)

Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Oswestry Disability Index [ODI] Score at 2-years Oswestry Disability Index Baseline, 2-year postoperative
Secondary Radiographic fusion Radiographic fusion at L4-5 levels as measured by computed tomography scan Baseline, 1-year postoperative
Secondary Change from baseline in walking ability at 2-years Walking test performed for 6 minutes Baseline, 2 years postoperative
Secondary Change from baseline in walking speed at 2-years Walking test performed for 6 minutes Baseline, 2 years postoperative
Secondary Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years Visual Analogue Scale Baseline, 2 year postoperative
Secondary Change from baseline in Short-Form 12 [SF-12] Scores at 2-years Short-Form 12 Baseline, 2 year postoperative
Secondary Change from baseline PROMIS Physical Function Scores at 2-years PROMIS Physical Function Baseline, 2 year postoperative
Secondary Change from baseline in Fear Avoidance Beliefs Metric at 2-years Fear Avoidance Beliefs Questionnaire Baseline, 2 year postoperative
Secondary Change from baseline in Pain Catastrophization Metric at 2-years Pain Catastrophization Questionnaire Baseline, 2 year postoperative
Secondary Change from baseline in Pain Neurophysiology Metric at 2-years Pain Neurophysiology Questionnaire Baseline, 2 year postoperative