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Spinal StenosisPhase 1/2CBPTNCT01131611

Cognitive-Behavioral Physical Therapy

A Phase 1/2 study testing CBPT in people with Spinal Stenosis, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall objective of this application is to conduct a two-group randomized controlled trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine surgery for degenerative conditions. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Spinal Stenosis
What is being tested?
CBPT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteUnited States
Study dates
Feb 2012to Apr 2014
Phase
Phase 1/2
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes;
  • Surgical treatment using laminectomy with or without arthrodesis (i.e., fusion);
  • Presence of back and/or lower extremity pain > 6 months;
  • No history of neurological movement disorder;
  • No presence of psychotic disease; and
  • TSK score > 39

Who cannot join

  • Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy (individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration and a shorter recovery time than individuals having arthrodesis or laminectomy without arthrodesis);
  • Patients having surgery for spinal deformity as the primary indication (patients with spinal deformity as the primary spinal disorder tend to have a different recovery trajectory compared to the inclusion population); and
  • Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt Orthopaedic Institute

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Cognitive-Behavioral Based Physical Therapy: Improving Surgical Spine Outcomes

The overall objective of this application is to conduct a two-group randomized controlled trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine surgery for degenerative conditions. Our central hypothesis is that incorporating cognitive and behavioral strategies into postoperative standard of care PT will improve surgical outcomes, through reductions in fear of movement and pain catastrophizing. We have established the feasibility of training therapists in the CBPT intervention, recruiting and retaining patients, and the procedures for data collection and study management. The long-term goal is to broaden the availability of well-accepted and effective CBT strategies by expanding the implementation from traditional providers, psychologists, to a group of providers, physical therapists, who routinely interact with musculoskeletal pain populations.

Read the detailed description

Despite surgical advances, up to 40% of patients continue to have chronic pain and functional disability after lumbar spine surgery. Our own data demonstrate that high fear of movement is a risk factor for increased pain and disability in this patient population. Cognitive-behavioral therapy (CBT) and physical therapy (PT) interventions targeting fear of movement have proven effective for decreasing persistent pain and functional disability in patients with chronic low back pain. However, the efficacy of a combined CBT and PT approach has not been well demonstrated in a surgical spine population. Therefore, we propose to conduct a two-group randomized controlled trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine surgery for degenerative conditions. We hypothesize that incorporating cognitive and behavioral strategies into postoperative standard of care PT will improve self-reported pain and disability and observed physical function, through reductions in fear of movement and pain catastrophizing (i.e., tendency to magnify pain sensations). This pilot study plans to recruit 80 patients with high postoperative fear of movement or pain catastrophizing. These eligible at-risk patients will be randomized to one of the two groups: (1) standard PT treatment + CBPT or (2) standard PT treatment + weekly phone calls to control for attention. The CBPT program consists of 1 in person and 5 telephone sessions and is based on well-accepted and effective CBT strategies. These strategies focus on relaxation, problem-solving training, cognitive restructuring, and behavioral self management. Primary outcomes include self-reported pain and disability as measured by the Brief Pain Inventory and the Oswestry Disability Index. Secondary outcomes consist of observed physical function as measured by performance-based tests of gait speed, balance, repeated chair stands, and mobility (Short Physical Performance Battery, Timed Up and Go). Outcome data will be collected at baseline (6 weeks after surgery), after treatment (3 months after surgery), and at 6 months following surgery. The proposed two-group RCT will provide estimates of effect sizes and sample sizes associated with the CBPT intervention and data on feasible recruitment and retention goals and the mechanisms through which the CBPT intervention affects long-term outcomes. This informative pilot data will guide a multicenter, three-group clinical trial to further validate the CBPT intervention. Our long-term objective is to broaden the availability of effective CBT strategies by expanding the implementation from traditional providers, psychologists, to a group of providers, physical therapists, who routinely interact with a large population of patients with musculoskeletal pain.

Conditions
Spinal Stenosis
Being tested
CBPT, Control-Attention
Keywords
Spinal Stenosis, Rehabilitation, Physical Therapy (specialty), Cognitive Behavior Therapy, Behavioral Research
Medical subject headings
Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBPTBehavioural

    Cognitive-Behavioral Based Physical Therapy

  • Control-AttentionOther

    Standard of Care + weekly phone calls

Study groups in NCT01131611
Study groupRoleWhat they receive
CBPT interventionExperimentalStandard PT treatment + CBPT
Receives: Behavioral: CBPT
Control-AttentionPlacebo comparatorStandard PT treatment + weekly phone calls
Receives: Other: Control-Attention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oswestry Disability Index

    The ODI measures disability

    Measured: 6 months post-discharge from therapy

Secondary outcomes (1)
  1. Brief Pain Inventory (BPI)

    The BPI measures pain intensity and pain interference

    Measured: 6 months post-discharge from therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2010 (estimated)
  2. Study startFeb 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01131611
Sponsor's protocol ID
100508
Acronym
CBPT
Status last verified
Jul 2014
First submitted
24 May 2010
Last updated
4 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CBPT in people with Spinal Stenosis, run by Vanderbilt University 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 6 inclusion and 3 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 4 Jul 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Oswestry Disability Index (time frame: 6 months post-discharge from therapy). 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 4 Jul 2014.

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