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Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04142177
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
VETERANS ONLY. Chronic low back pain (cLBP) is common. Most Americans will have at least one episode of low back pain in their lifetimes. Approximately 50% of all US Veterans have chronic pain, and CLBP is the most common type of pain in this population. This study will use a sequential randomized, pragmatic, 2-step comparative effectiveness study design. The main goal is to identify the best approach for treating cLBP using commonly recommended non-surgical and non-pharmacological options. The first step compares continued care and active monitoring (CCAM) to internet-based pain self-management (Pain EASE) and an enhanced physical therapy intervention that combines Pain EASE with tailored exercise and physical activity. Patients who do not have a significant decrease in pain interference (a functional outcome) in Step 1 and those desiring additional treatment will be randomized in Step 2 to yoga, spinal manipulation therapy (SMT), or therapist-delivered cognitive behavioral therapy (CBT). Participants proceeding to randomization in Step 2 will be allowed to exclude up to one of the three Step 2 treatments based on their preferences. The investigators' primary hypothesis for the first treatment step is that an enhanced physical therapy intervention that combines pain self-management education with a tailored exercise program will reduce pain interference greater than internet-based pain self-management alone or CCAM in Veterans with cLBP. The primary outcome is change in pain interference at 3 months, measured using the Brief Pain Inventory (BPI) pain interference subscale. Study participants will be followed for one year after initiation of their final study treatments to assess the durability of treatment effects. The study plans to randomize 2529 patients across 20 centers.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: Pain EASE Procedure: Tailored exercise Other: Continued Care and Active Monitoring Behavioral: Cognitive Behavioral Therapy (CBT) Procedure: Spinal Manipulation Therapy (SMT) Procedure: Yoga Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2529 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: sequential randomized, pragmatic, 2-step comparative effectiveness study design
Masking: Single (Outcomes Assessor)
Masking Description: This is a single-blinded study. The participants, Local Site Investigators (LSIs) and Site Coordinators will have the information on participant treatment assignment. Centralized Outcome Assessors (COAs) who collect primary and secondary outcome measures over the phone will be blinded to treatment assignment. The study team who manage the day-to-day study operations (including Study Chairs, National Study Coordinator, and study team members at Cooperative Studies Program Coordinating Centers [CSPCC] and Clinical Research Pharmacy Coordinating Centers [CRPCC] may have information on specific individual participant treatment assignment only when the information is needed to perform their work.
Primary Purpose: Treatment
Official Title: CSP #2009 - Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response: The SCEPTER Trial
Actual Study Start Date : June 13, 2022
Estimated Primary Completion Date : June 17, 2025
Estimated Study Completion Date : June 17, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Internet-based pain self-management program
Internet-based treatment (Step 1 Treatment)
 Other: Pain EASE
The internet-based pain self-management program consists of open access to the Pain EASE program (Pain E-health for Activity, Skills, and Education) for the duration of participation in the trial. Pain EASE has 10 pain coping skill modules: pain education, setting personal goals, planning meaningful activities, physical activity (stretching, body mechanics, and a pedometer-based walking program), relaxation, developing healthy thinking patterns, pacing and problem-solving, improving sleep, effective communication, and future planning.
Active Comparator: Enhanced Physical Therapy
Intervention that combines the internet-based pain self-management program with tailored exercise and physical activity guided by a physical therapist (Step 1 treatment)
 Other: Pain EASE
The internet-based pain self-management program consists of open access to the Pain EASE program (Pain E-health for Activity, Skills, and Education) for the duration of participation in the trial. Pain EASE has 10 pain coping skill modules: pain education, setting personal goals, planning meaningful activities, physical activity (stretching, body mechanics, and a pedometer-based walking program), relaxation, developing healthy thinking patterns, pacing and problem-solving, improving sleep, effective communication, and future planning.

Procedure: Tailored exercise
Findings from the initial examination and the Keele STarT Back Screening Tool (Hill, et al., 2011) will be used by the physical therapist to guide and tailor the intervention to individual participants which will involve up to 8 treatment sessions with ongoing home exercise. For most participants, exercise and physical activity will focus on walking in addition to motor control and stabilization exercises for the low back with flexibility exercises when lumbar spine stiffness is present.
Placebo Comparator: Continued Care and Active Monitoring (CCAM)
CCAM will not be standardized keeping in line with the pragmatic nature of this trial. CCAM may be variable across sites and for individual participants reflecting de facto clinical practice for cLBP. Clinical practice may involve pharmacological and non-pharmacological treatments for cLBP. Current analgesics (including opioids, acetaminophen, NSAIDs, topical analgesics (capsaicin), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, skeletal muscle relaxants, and alpha-2-delta ligands (gabapentin-like drugs)) and non-pharmacological treatments may be continued by participants. CCAM participants will be encouraged to discuss pain problems with their treating physician, but not begin new treatments if possible. Patients will specifically be discouraged from starting CBT, chiropractic, or yoga. Other than this, there will be no attempt by study personnel to influence pain management (Step 1 Treatment)
 Other: Continued Care and Active Monitoring
CCAM will not be standardized keeping in line with the pragmatic nature of this trial. CCAM may be variable across sites and for individual participants reflecting de facto clinical practice for cLBP. Clinical practice may involve pharmacological and non-pharmacological treatments for cLBP. Current analgesics (including opioids, acetaminophen, NSAIDs, topical analgesics (capsaicin), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, skeletal muscle relaxants, and alpha-2-delta ligands (gabapentin-like drugs)) and non-pharmacological treatments may be continued by participants. CCAM participants will be encouraged to discuss pain problems with their treating physician, but not begin new treatments if possible. Patients will specifically be discouraged from starting CBT, chiropractic, or yoga. Other than this, there will be no attempt by study personnel to influence pain management.
Active Comparator: Cognitive Behavioral Therapy (CBT)
Participants randomized to CBT in Step 2 will receive treatment with a trained therapist using the VA's CBT-chronic pain (CBT-CP) protocol involving one planning session and 9 treatment sessions (10 total) over 3 months (Step 2 Treatment).
 Behavioral: Cognitive Behavioral Therapy (CBT)
Participants randomized to CBT in Step 2 will receive treatment with a trained therapist using the VA's CBT-chronic pain (CBT-CP) protocol involving one planning session and 9 treatment sessions (10 total) over 3 months. The VA's CBT-CP protocol consists of 11 core CBT-CP modules that can be completed in up to 10 sessions. Weekly, individual sessions of 45-50 minutes are recommended, although it is recognized that bi-weekly or other arrangements are often made to fit practical needs.
Active Comparator: Spinal Manipulation Therapy (SMT)
After examination by a qualified Doctor of Chiropractic (DC), a SMT intervention consisting of up to 10 sessions over 3 months will be designed focusing on spinal manipulation and/or mobilization of the lower thoracic, lumbar and/or sacroiliac joints. Adjunctive use of myofascial and/or stretching techniques are allowed as they are commonly used along with SMT, and can be considered a standard accompaniment to SMT (Step 2 Treatment).
 Procedure: Spinal Manipulation Therapy (SMT)
After examination by a qualified Doctor of Chiropractic (DC), a SMT intervention consisting of up to 10 sessions over 3 months will be designed focusing on spinal manipulation and/or mobilization of the lower thoracic, lumbar and/or sacroiliac joints. Adjunctive use of myofascial and/or stretching techniques are allowed as they are commonly used along with SMT, and can be considered a standard accompaniment to SMT.
Active Comparator: Yoga
The Yoga for Veterans with cLBP program consists of up to 10 weekly, 60-minute instructor-led sessions along with 15-20 minutes of yoga practiced at home each non-session day. The initial session is 75 minutes (15 minutes longer than the other sessions). The yoga program can be considered classical hatha yoga with influences from Iyengar and Viniyoga yoga. These styles emphasize modifications and adaptations including the use of props such as straps and blocks to minimize the risk of injury and make the poses accessible to people with health problems and limitations (Iyengar, 1979). The instructor leads participants through a series of 23 yoga poses (32 total variations) at a slow-moderate pace (Step 2 Treatment).
 Procedure: Yoga
The Yoga for Veterans with cLBP program consists of up to 10 weekly, 60-minute instructor-led sessions along with 15-20 minutes of yoga practiced at home each non-session day. The initial session is 75 minutes (15 minutes longer than the other sessions). The yoga program can be considered classical hatha yoga with influences from Iyengar and Viniyoga yoga. These styles emphasize modifications and adaptations including the use of props such as straps and blocks to minimize the risk of injury and make the poses accessible to people with health problems and limitations (Iyengar, 1979). The instructor leads participants through a series of 23 yoga poses (32 total variations) at a slow-moderate pace.


Outcome Measures
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Primary Outcome Measures :
  1. Brief Pain Inventory (BPI) Interference scale [ Time Frame: 3 months post-treatment ]
    Pain interference will be assessed with the Brief Pain Inventory (BPI) Interference subscale, a validated measure that rates pain interference of pain on 7 items (mood, physical activity, work, social activity, relations, sleep, and life enjoyment). BPI scores range 0 to 10, with higher scores representing worse pain interference, and a 1-point change considered clinically important. Linear mixed effects models will be used to compare the primary outcome (change in pain interference score from pre-treatment to 3 months after treatment) between Step 1 treatments in all participants and between Step 2 treatments in Step 1 non-responders. The mixed effects model will include treatment and study site as fixed effects, and therapist as random effects. For the comparison of Step 1 treatments, the model will also include a fixed effect for opioid use at study entry.


Eligibility Criteria
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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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following criteria:

  1. Low back pain

    1. present for at least 6 months,
    2. present most days or everyday,
    3. interferes the most with activities considering all of the places where the patient experiences pain;
  2. Pain, Enjoyment, General Activity (PEG) score of 4 or greater;
  3. Veteran age 18 years or older, either sex, any racial or ethnic background;
  4. Able to comprehend and willing to sign the study informed consent form;
  5. Able to attend in-person treatment sessions;
  6. Anticipate continuing care at the enrolling VA for the period of the study;
  7. Stable access to the internet at home, work, or other location (e.g. mobile phone), and an email address.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Currently enrolled in any other interventional study unless exempted by CSP;
  2. Acute or chronic illness that would prevent the Veteran from receiving study treatments offered (e.g., uncontrolled hypertension, recent myocardial infarction within the last 6 months, unstable angina, acute congestive heart failure);
  3. Neurological impairment related to disease of the spine or other causes preventing participation in any of the treatment modalities under study;
  4. Current or recent (last 3 months) treatment involving Cognitive Behavioral Therapy, Spinal manipulation therapy, or Yoga;
  5. Current severe alcohol or substance abuse use disorder;
  6. Severe psychiatric illness (e.g. current psychosis, current suicidal ideation, or psychiatric illness requiring hospitalization within the last 6 months);
  7. Undergoing evaluation for back surgery or planned back surgery;
  8. Cognitive or severe hearing or visual impairment preventing participation in treatment options or outcome measure assessments;
  9. Pregnancy;
  10. Refusal to provide written consent.
Contacts and Locations
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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): NCT04142177


Contacts
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Contact: Colleen M Fitzsimmons (650) 493-5000 ext 21123 Colleen.Fitzsimmons@va.gov

Locations
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Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Study Chair: David J Clark, PhD MD VA Palo Alto Health Care System, Palo Alto, CA
Study Chair: Matthew J. Bair, MD MS Richard L. Roudebush VA Medical Center, Indianapolis, IN
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04142177    
Other Study ID Numbers: 2009
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
chronic low back pain
severe low back pain
pain
non-pharmacological treatment
self-management
 physical therapy
exercise
yoga
cognitive behavioral therapy
spinal manipulation therapy
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations