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Completed

NCT Number: NCT03033212

Single-Level TLIF: Post-Fusion Rehabilitation

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.

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Key information

Conditions

Degenerative Spinal Cord Disease Nervous System Diseases Neurodegenerative Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carla Edwards

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapist-Guided Rehabilitation

Other

Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.

Self-Guided Rehabilitation

Other

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

Primary outcomes

  1. Change from baseline in Oswestry Disability Index [ODI] Score at 2-years

    Time frame: Baseline, 2-year postoperative

    Oswestry Disability Index

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2017
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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