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Single-Level TLIF: Post-Fusion Rehabilitation

Primary Purpose

Degenerative Spinal Cord Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Therapist-Guided Rehabilitation

Self-Guided Rehabilitation

About this trial

This is an interventional treatment trial for Degenerative Spinal Cord Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Carla Edwards

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Early Structured Rehabilitation

Delayed Rehabilitation

Self Rehabilitation

Arm Description

Patients will begin Therapist-Guided Rehabilitation at 7 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.

Patients will begin Therapist-Guided Rehabilitation at 13 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.

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.

Outcomes

Primary Outcome Measures

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

Oswestry Disability Index

Secondary Outcome Measures

Radiographic fusion

Radiographic fusion at L4-5 levels as measured by computed tomography scan

Change from baseline in walking ability at 2-years

Walking test performed for 6 minutes

Change from baseline in walking speed at 2-years

Walking test performed for 6 minutes

Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years

Visual Analogue Scale

Change from baseline in Short-Form 12 [SF-12] Scores at 2-years

Short-Form 12

Change from baseline PROMIS Physical Function Scores at 2-years

PROMIS Physical Function

Change from baseline in Fear Avoidance Beliefs Metric at 2-years

Fear Avoidance Beliefs Questionnaire

Change from baseline in Pain Catastrophization Metric at 2-years

Pain Catastrophization Questionnaire

Change from baseline in Pain Neurophysiology Metric at 2-years

Pain Neurophysiology Questionnaire

Full Information

NCT ID

NCT03033212

First Posted

December 15, 2016

Last Updated

September 8, 2021

Sponsor

Rush University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03033212

Brief Title

Single-Level TLIF: Post-Fusion Rehabilitation

Official Title

Single-Level TLIF: Post-Fusion Rehabilitation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 21, 2017 (Actual)

Primary Completion Date

September 1, 2021 (Actual)

Study Completion Date

September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Spinal Cord Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early Structured Rehabilitation

Arm Type

Experimental

Arm Description

Patients will begin Therapist-Guided Rehabilitation at 7 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.

Arm Title

Delayed Rehabilitation

Arm Type

Experimental

Arm Description

Patients will begin Therapist-Guided Rehabilitation at 13 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.

Arm Title

Self Rehabilitation

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Therapist-Guided Rehabilitation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Self-Guided Rehabilitation

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Oswestry Disability Index

Time Frame

Baseline, 2-year postoperative

Secondary Outcome Measure Information:

Title

Radiographic fusion

Description

Radiographic fusion at L4-5 levels as measured by computed tomography scan

Time Frame

Baseline, 1-year postoperative

Title

Change from baseline in walking ability at 2-years

Description

Walking test performed for 6 minutes

Time Frame

Baseline, 2 years postoperative

Title

Change from baseline in walking speed at 2-years

Description

Walking test performed for 6 minutes

Time Frame

Baseline, 2 years postoperative

Title

Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years

Description

Visual Analogue Scale

Time Frame