Degenerative Spinal Cord DiseaseNCT03033212
Single-Level TLIF: Post-Fusion Rehabilitation
A study testing Therapist-Guided Rehabilitation and Self-Guided Rehabilitation in people with Degenerative Spinal Cord Disease, run by Rush University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Spinal Cord Disease
- What is being tested?
- Therapist-Guided Rehabilitation and Self-Guided Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Degenerative Spinal Cord Disease
- Being tested
- Therapist-Guided Rehabilitation, Self-Guided Rehabilitation
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-Guided RehabilitationOther
Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
Self-Guided RehabilitationOther
Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| Early Structured Rehabilitation | Experimental | Patients will begin Therapist-Guided Rehabilitation at 7 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks. Receives: Other: Therapist-Guided Rehabilitation |
| Delayed Rehabilitation | Experimental | Patients will begin Therapist-Guided Rehabilitation at 13 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks. Receives: Other: Therapist-Guided Rehabilitation |
| Self Rehabilitation | Active comparator | 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. Receives: Other: Self-Guided Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Oswestry Disability Index [ODI] Score at 2-years
Oswestry Disability Index
Measured: Baseline, 2-year postoperative
Secondary outcomes (9)
Radiographic fusion
Radiographic fusion at L4-5 levels as measured by computed tomography scan
Measured: Baseline, 1-year postoperative
Change from baseline in walking ability at 2-years
Walking test performed for 6 minutes
Measured: Baseline, 2 years postoperative
Change from baseline in walking speed at 2-years
Walking test performed for 6 minutes
Measured: Baseline, 2 years postoperative
Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years
Visual Analogue Scale
Measured: Baseline, 2 year postoperative
Change from baseline in Short-Form 12 [SF-12] Scores at 2-years
Short-Form 12
Measured: Baseline, 2 year postoperative
Change from baseline PROMIS Physical Function Scores at 2-years
PROMIS Physical Function
Measured: Baseline, 2 year postoperative
Change from baseline in Fear Avoidance Beliefs Metric at 2-years
Fear Avoidance Beliefs Questionnaire
Measured: Baseline, 2 year postoperative
Change from baseline in Pain Catastrophization Metric at 2-years
Pain Catastrophization Questionnaire
Measured: Baseline, 2 year postoperative
Change from baseline in Pain Neurophysiology Metric at 2-years
Pain Neurophysiology Questionnaire
Measured: Baseline, 2 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start21 Aug 2017
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Spinal Cord DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Edwards, Rush University Medical Center
- Investigators
- Frank M Phillips, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033212
- Sponsor's protocol ID
- MORPFR001
- Status last verified
- Sep 2021
- First submitted
- 15 Dec 2016
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Level TLIF: Post-Fusion Rehabilitation
- ClinicalTrials.gov ID
- NCT03033212
- Acronym / sponsor ID
- MORPFR001
- Conditions
- Degenerative Spinal Cord Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Structured Rehabilitation | Experimental | Other: Therapist-Guided RehabilitationPatients will begin Therapist-Guided Rehabilitation at 7 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks. |
| Delayed Rehabilitation | Experimental | Other: Therapist-Guided RehabilitationPatients will begin Therapist-Guided Rehabilitation at 13 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks. |
| Self Rehabilitation | Active comparator | Other: Self-Guided RehabilitationPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapist-Guided RehabilitationRehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises. | Other | Delayed Rehabilitation, Early Structured Rehabilitation |
| Self-Guided RehabilitationRehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises. | Other | Self Rehabilitation |
Primary outcome
Change from baseline in Oswestry Disability Index [ODI] Score at 2-years
Time frame: Baseline, 2-year postoperative
Oswestry Disability Index
9 secondary outcomes
Radiographic fusion
Time frame: Baseline, 1-year postoperative
Change from baseline in walking ability at 2-years
Time frame: Baseline, 2 years postoperative
Change from baseline in walking speed at 2-years
Time frame: Baseline, 2 years postoperative
Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years
Time frame: Baseline, 2 year postoperative
Change from baseline in Short-Form 12 [SF-12] Scores at 2-years
Time frame: Baseline, 2 year postoperative
Change from baseline PROMIS Physical Function Scores at 2-years
Time frame: Baseline, 2 year postoperative
Change from baseline in Fear Avoidance Beliefs Metric at 2-years
Time frame: Baseline, 2 year postoperative
Change from baseline in Pain Catastrophization Metric at 2-years
Time frame: Baseline, 2 year postoperative
Change from baseline in Pain Neurophysiology Metric at 2-years
Time frame: Baseline, 2 year postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank M Phillips, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist-Guided Rehabilitation and Self-Guided Rehabilitation in people with Degenerative Spinal Cord Disease, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Oswestry Disability Index [ODI] Score at 2-years (time frame: Baseline, 2-year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.