Spinal Stenosis LumbarNCT02982291
Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis
A study testing Williams flexion protocol and Focused spinal stenosis rehabilitation in people with Spinal Stenosis Lumbar, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain, as well as by weakness precipitated by walking and prolonged standing. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- Williams flexion protocol and Focused spinal stenosis rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 1 Feb 2018
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lumbar spinal stenosis with neurogenic claudication
- Symptoms present for at least 3 months
- Moderate to severe acquired or congenital LSS based on radiological evaluation
- Lumbar MRI obtained within the past 12 months prior to initial physical therapy visit
- 40 years of age or older
- Body mass index less than or equal to 35
- Can tolerate a 6-min treadmill test
- Willing to comply with home exercises as prescribed
Who cannot join
- Acute disc herniation
- Grade 3 or greater spondylolisthesis
- Rheumatoid or autoimmune conditions (e.g., ankylosing spondylitis)
- Active spinal compression fractures
- Knee surgery in the previous 6 months (e.g., total knee arthroplasty)
- Previous spinal fusion
Show all 11Show fewer
- Absence of pedal pulses
- Inflammation/infectious process
- Myelopathy
- Psychiatric disorder preventing informed consent or participation in assigned physical therapy sessions
- Patients with pending litigation or workers compensation
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Focused Spinal Stenosis Rehabilitation Program vs. Generic Williams Flexion Protocol
Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain, as well as by weakness precipitated by walking and prolonged standing. Self-management options include physical therapy, which includes exercise as a core component for improving the flexibility and mobility of the spine and hips. A Williams flexion protocol has historically been used to treat low-back pain following degenerative changes to the posterior elements of the lumbar spine. However, few studies have been done to validate the efficacy of this protocol. A more focused treatment protocol may be more efficacious. Patients in this study will be randomized to receive either the generic physical therapy protocol (15 sessions) or the focused rehabilitation program (5 sessions). The sessions will take place over the course of 6 months. Outcomes will be assessed using validated questionnaires and physical function tests.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- Williams flexion protocol, Focused spinal stenosis rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Williams flexion protocolProcedure or surgery
The Williams flexion protocol group will participate in 15 treatment sessions.
Focused spinal stenosis rehabilitationProcedure or surgery
The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Not described Receives: Procedure: Williams flexion protocol |
| Individualized | Experimental | Not described Receives: Procedure: Focused spinal stenosis rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional ability
Change in functional ability will be assessed using the Oswestry Disability Index. The minimum clinically important difference of the ODI has been documented in the literature as a 13-point change.
Measured: Up to 1 year after initial physical therapy visit
Secondary outcomes (4)
Pain
Pain will be measured by the Numerical Pain Rating Scale, on a 0-10 scale, where 0=no pain and 10=worst pain.
Measured: Up to 1 year after initial physical therapy visit
Quality of life
Quality of life will be measured using the PROMIS Physical Function 10a Questionnaire.
Measured: Up to 1 year after initial physical therapy visit
Tolerance to exercise
The Timed Treadmill Test, which requires patients to walk on a treadmill at 1.2 miles per hour and a 1% grade and report when they begin experiencing typical exercise-induced symptoms, will be used.
Measured: Up to 1 year after initial physical therapy visit
Physical ability
Physical ability will be assessed upon exams that measure balance, hip abductor strength, range of motion, etc.
Measured: Up to 1 year after initial physical therapy visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 May 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Why it stopped: Difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Turner, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982291
- Sponsor's protocol ID
- 2015-182
- Status last verified
- Feb 2018
- First submitted
- 1 Dec 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Spinal Stenosis Rehabilitation Program vs. Generic Williams Flexion Protocol
- ClinicalTrials.gov ID
- NCT02982291
- Acronym / sponsor ID
- 2015-182
- Conditions
- Spinal Stenosis Lumbar
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 5 Dec 2016 (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.
Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain, as well as by weakness precipitated by walking and prolonged standing. Self-management options include physical therapy, which includes exercise as a core component for improving the flexibility and mobility of the spine and hips. A Williams flexion protocol has historically been used to treat low-back pain following degenerative changes to the posterior elements of the lumbar spine. However, few studies have been done to validate the efficacy of this protocol. A more focused treatment protocol may be more efficacious. Patients in this study will be randomized to receive either the generic physical therapy protocol (15 sessions) or the focused rehabilitation program (5 sessions). The sessions will take place over the course of 6 months. Outcomes will be assessed using validated questionnaires and physical function tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Procedure: Williams flexion protocol |
| Individualized | Experimental | Procedure: Focused spinal stenosis rehabilitation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Lumbar spinal stenosis with neurogenic claudication
- Symptoms present for at least 3 months
- Moderate to severe acquired or congenital LSS based on radiological evaluation
- Lumbar MRI obtained within the past 12 months prior to initial physical therapy visit
- 40 years of age or older
Key exclusion criteria (11 listed)
- Acute disc herniation
- Grade 3 or greater spondylolisthesis
- Rheumatoid or autoimmune conditions (e.g., ankylosing spondylitis)
- Active spinal compression fractures
- Knee surgery in the previous 6 months (e.g., total knee arthroplasty)
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 |
|---|---|---|
| Williams flexion protocolThe Williams flexion protocol group will participate in 15 treatment sessions. | Procedure or surgery | Standard |
| Focused spinal stenosis rehabilitationThe focused spinal stenosis rehabilitation group will participate in 5 treatment sessions. | Procedure or surgery | Individualized |
Primary outcome
Change in functional ability
Time frame: Up to 1 year after initial physical therapy visit
Change in functional ability will be assessed using the Oswestry Disability Index. The minimum clinically important difference of the ODI has been documented in the literature as a 13-point change.
4 secondary outcomes
Pain
Time frame: Up to 1 year after initial physical therapy visit
Quality of life
Time frame: Up to 1 year after initial physical therapy visit
Tolerance to exercise
Time frame: Up to 1 year after initial physical therapy visit
Physical ability
Time frame: Up to 1 year after initial physical therapy visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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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.
Robert Turner principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Williams flexion protocol and Focused spinal stenosis rehabilitation in people with Spinal Stenosis Lumbar, run by Hospital for Special Surgery, New York 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 8 inclusion and 11 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: withdrawn, as of the sponsor's last update on 5 Feb 2018. 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 was withdrawn before enrolling participants, so there are no results.
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 in functional ability (time frame: Up to 1 year after initial physical therapy visit). 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 5 Feb 2018.