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Single-Level TLIF: Post-Fusion Rehabilitation

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ClinicalTrials.gov Identifier: NCT03033212
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Frank M. Phillips, MD, 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.

Condition or disease Intervention/treatment Phase
Degenerative Spinal Cord Disease Other: Therapist-Guided Rehabilitation Other: Self-Guided Rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Single-Level TLIF: Post-Fusion Rehabilitation
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from baseline in Oswestry Disability Index [ODI] Score at 2-years [ Time Frame: Baseline, 2-year postoperative ]
    Oswestry Disability Index


Secondary Outcome Measures :
  1. Radiographic fusion [ Time Frame: Baseline, 1-year postoperative ]
    Radiographic fusion at L4-5 levels as measured by computed tomography scan

  2. Change from baseline in walking ability at 2-years [ Time Frame: Baseline, 2 years postoperative ]
    Walking test performed for 6 minutes

  3. Change from baseline in walking speed at 2-years [ Time Frame: Baseline, 2 years postoperative ]
    Walking test performed for 6 minutes

  4. Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years [ Time Frame: Baseline, 2 year postoperative ]
    Visual Analogue Scale

  5. Change from baseline in Short-Form 12 [SF-12] Scores at 2-years [ Time Frame: Baseline, 2 year postoperative ]
    Short-Form 12

  6. Change from baseline PROMIS Physical Function Scores at 2-years [ Time Frame: Baseline, 2 year postoperative ]
    PROMIS Physical Function

  7. Change from baseline in Fear Avoidance Beliefs Metric at 2-years [ Time Frame: Baseline, 2 year postoperative ]
    Fear Avoidance Beliefs Questionnaire

  8. Change from baseline in Pain Catastrophization Metric at 2-years [ Time Frame: Baseline, 2 year postoperative ]
    Pain Catastrophization Questionnaire

  9. Change from baseline in Pain Neurophysiology Metric at 2-years [ Time Frame: Baseline, 2 year postoperative ]
    Pain Neurophysiology Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033212


Contacts
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Contact: Susan A Dvojack, MS 3129426689 susan_dvojack@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Susan Dvojack    312-942-6689    Susan_Dvojack@rush.edu   
Principal Investigator: Frank M Phillips, MD         
Sub-Investigator: Kern Singh, MD         
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Frank M Phillips, MD Rush University Medical Center
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Responsible Party: Frank M. Phillips, MD, Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03033212    
Other Study ID Numbers: MORPFR001
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases