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Optimize Low Back Pain

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ClinicalTrials.gov Identifier: NCT03859713
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Julie Fritz, University of Utah

Brief Summary:
The objective of this study is to improve health care for patients with chronic LBP and increase the likelihood that patients obtain outcomes that matter most to them. The investigators will accomplish our goal using a sequential multiple randomization (SMART) design comparing the effectiveness of Phase 1 (PT v. CBT) treatments for patients with chronic LBP; and among patient non-responsive to Phase I treatment, compare the effectiveness of Phase II treatments (switching to PT or CBT v. mindfulness). Effectiveness will be based on patient-centered outcomes. Sub-aims will compare main effects of Phase 1 and 2 treatment options and the sequencing effects of different treatment combinations.

Condition or disease Intervention/treatment Phase
Low Back Pain Chronic Pain Behavioral: Physical Therapy Behavioral: Cognitive Behavioral Therapy Behavioral: Mindfulness Phase 3

Detailed Description:

The study uses a sequential multiple randomization (SMART) design. The study will compare the effectiveness of common first-line treatments for chronic LBP: PT or CBT. Initial treatment will be 8 weeks duration with re-evaluation at 10-weeks after enrollment to allow time to complete treatment. At the 10-week assessment researchers will examine if the patient has responded to initial treatment using a patient-centered, validated definition of successful response based on 50% improvement in the Oswestry Disability Index (ODI). Patients who are responders to initial treatment will receive up to 2 additional sessions of the same treatment to assist transition to self-management. Non-responders will be re-randomized to a second treatment strategy of either switching to the other initial treatment (i.e., patients receiving PT switch to CBT or vice versa), or mindfulness. The second treatment phase is also 8 weeks in duration. Additional follow-ups occur 26- and 52 weeks after enrollment.

The study has two co-primary outcomes; function and pain. The investigators will use the ODI, a well-validated, reliable and responsive patient-reported measure of LBP-related function recommended by the NIH Back Pain Task Force. The investigators will assess pain intensity with 0-10 ratings ('0' indicating no pain and '10' worst imaginable pain). Separate ratings are made for current, worst and best pain over the past 24 hours with an average computed to represent pain intensity. Secondary outcomes will assess dimensions of quality of life, work and healthcare utilization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 945 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Participants and clinicians cannot be blind to treatment received. The investigators will remain blind to group assignment and follow-up assessments will be conducted by assessors who are blind to treatment group.
Primary Purpose: Treatment
Official Title: Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: PT followed by Switching to CBT in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
Behavioral: Physical Therapy
Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.

Behavioral: Cognitive Behavioral Therapy
Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction

Experimental: PT followed by Mindfulness in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
Behavioral: Physical Therapy
Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.

Behavioral: Mindfulness
Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.
Other Name: Mindfulness-Oriented Recovery Enhancement

Experimental: CBT followed by Switching to PT in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
Behavioral: Physical Therapy
Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.

Behavioral: Cognitive Behavioral Therapy
Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction

Experimental: CBT followed by Mindfulness in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
Behavioral: Cognitive Behavioral Therapy
Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction

Behavioral: Mindfulness
Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.
Other Name: Mindfulness-Oriented Recovery Enhancement




Primary Outcome Measures :
  1. Change in Oswestry Disability Index from baseline to 10 weeks [ Time Frame: baseline, 10 weeks ]
    Back pain specific measure of functional disability to address Aim 1

  2. Change in Oswestry Disability Index from baseline to 52 weeks [ Time Frame: baseline, 52 weeks ]
    Back pain specific measure of functional disability to address Aim 2

  3. Change in Numeric Pain Intensity Rating from baseline to 10 weeks [ Time Frame: baseline, 10 weeks ]
    0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 1.

  4. Change in Numeric Pain Intensity Rating from baseline to 52 weeks [ Time Frame: baseline, 52 weeks ]
    0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 2.


Secondary Outcome Measures :
  1. Health-related Quality of Life [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    PROMIS-29 score assessed as a T-score with mean = 50 and SD = 10

  2. Pain Interference [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  3. Fatigue [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  4. Sleep Disturbance [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  5. Anxiety [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    PROMIS 4-item short form (part of PROMIS-29)assessed as a T-score with mean = 50 and SD = 10

  6. Depression [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  7. Social Role Participation [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10

  8. Health Care Utilization [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    Utilization of surgery, injections, imaging or other discrete interventions for low back pain

  9. Opioid Utilization [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    Use of opioids for pain management

  10. Treatment Side Effects [ Time Frame: 10 weeks, 26 weeks ]
    Self-reported physical or psychological side effects of study treatments

  11. Treatment Responder [ Time Frame: baseline, 10 weeks, 26 weeks, 52 weeks ]
    Dichotomous outcome based on achieving at least 50% improvement on ODI from baselin score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 64 years at the time of enrollment.
  • Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem for you? and 2) How often has LBP been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP.
  • Healthcare visit for LBP in the past 90 days.
  • At least moderate levels of pain and disability requiring ODI score >24 and pain intensity rating > 4.

Exclusion Criteria:

  • Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
  • Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc.
  • Knowingly pregnant
  • Has received physical therapy for LBP; or CBT or mindfulness for any reason with a provider in prior 90 days
  • Currently receiving substance use disorder treatment
  • Any lumbar spine surgery in the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859713


Contacts
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Contact: Elizabeth Lane, PT, DPT 801-581-6861 Elizabeth.Lane@hsc.utah.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tricia Kirkhart, MS    410-502-4453    pkirkha1@jhmi.edu   
Principal Investigator: Richard Skolasky, ScD         
United States, Utah
Intermountain Health Care Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Gerard Brennan, PT, PhD    801-314-2529    Gerard.Brennan@imail.org   
Contact: Kate Minick, PT, DPT    801-314-2529    Kate.Minick@imail.org   
The University of Utah Healthcare System Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Elizabeth Lane, PT, DPT    801-581-6861    Elizabeth.Lane@hsc.utah.edu   
Principal Investigator: Julie M Fritz, PT, PhD         
Sponsors and Collaborators
University of Utah
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Julie Fritz, PT, PhD University of Utah
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julie Fritz, Distinguished Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03859713    
Other Study ID Numbers: 00116150
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Fritz, University of Utah:
Physical Therapy
Cognitive Behavioral Therapy
Mindfulness
Adaptive Treatment Regimens
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations