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The BEST Trial: Biomarkers for Evaluating Spine Treatments (BEST)

Primary Purpose

Chronic Low-back Pain

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Enhanced Self-Care (ESC)

Acceptance and Commitment Therapy (ACT)

Evidence-Based Exercise and Manual Therapy (EBEM)

Duloxetine

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Pain, Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be eligible, an individual must meet all of the following inclusion criteria:

Ability to read and understand English
Provision of signed and dated informed consent form(s)
Willing and able to receive study-related messages and survey links via email
Willing and able to receive study-related phone calls
Age 18 years old or older
Low-back pain for at least 3 months and occurring on at least half the days in the past 6 months
Contraindicated to no more than one of the study interventions at the time of eligibility assessment(s)
Eligible to receive at least three of the four study interventions and willing to receive any intervention for which they are eligible
A PEG score 4 or higher at two time points: 1) screening prior to the Run-in period and 2) screening prior to baseline (Visit 0)
Willing and able to undergo required phenotyping
Regular reliable access to an internet-enabled device such as a smart phone, tablet, or laptop computer
Meet Run-in period engagement eligibility criteria:
- Completion of two Run-in study information modules
- Response to 10 of 14 texts/emails
Low-back pain more severe than pain in other parts of the body
Available to complete the full study protocol (approximately 9 months)

Exclusion Criteria:

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

Pregnant at the time of Visit 0 (Baseline)
Affirmative participant response to any of the following conditions:
- Progressive neurodegenerative disease
- History of discitis osteomyelitis (spine infection) or spine tumor
- History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, or psoriatic arthritis, lupus or other autoimmune disorder
- History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength <4/5 on manual motor testing)
- Diagnosis of any vertebral fracture in the last 6 months
- Osteoporosis requiring pharmacologic treatment other than vitamin D, calcium supplements, or bisphosphonates.
- History of any bone-related cancer or cancer that metastasized to the bone
- Currently in treatment for any non-skin cancer or plan to start non-skin cancer treatment in the next 12 months
- History of any non-skin cancer treatment in the last 24 months
- Visual or hearing difficulties that would preclude participation
- Uncontrolled drug/alcohol addiction
- Individuals actively pursuing disability or workers compensation or involved in active personal injury-related litigation
- Currently participating in another interventional pain study
Any condition that, in the opinion of the investigator, would preclude the patient from being able to safely participate in in the trial

Sites / Locations

Stanford UniversityRecruiting
University of California, San DiegoRecruiting
University of California, San FranciscoRecruiting
University of Kansas Health SystemRecruiting
Massachusetts General Hospital/Brigham Women's Hospital, Harvard Medical SchoolRecruiting
University of MichiganRecruiting
University of North Carolina Hospital Pain Management ClinicRecruiting
Atrium Health Wake Forest BaptistRecruiting
The Ohio State University Wexner Medical CenterRecruiting
University of PittsburghRecruiting
Medical University of South CarolinaRecruiting
University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Treatment Period 1: Enhanced Self-Care (ESC)

Treatment Period 1: Acceptance and Commitment Therapy (ACT)

Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)

Treatment Period 1: Duloxetine

Arm Description

This arm includes participants who are randomized to ESC in Treatment Period 1. Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ESC or be randomized to augment ESC with an additional treatment during Treatment Period 2.

This arm includes participants who are randomized to ACT in Treatment Period 1. Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ACT, augment ACT with an additional treatment, or switch to a new treatment during Treatment Period 2.

This arm includes participants who are randomized to EBEM in Treatment Period 1. Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on EBEM, augment EBEM with an additional treatment, or switch to a new treatment during Treatment Period 2.

This arm includes participants who are randomized to Duloxetine in Treatment Period 1. Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on Duloxetine, augment Duloxetine with an additional treatment, or switch to a new treatment during Treatment Period 2.

Outcomes

Primary Outcome Measures

Change in Patient-Reported Pain Intensity and Interference Score

Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from -10 to 10, with higher scores indicating increased pain intensity and interference at 24 Weeks compared to Baseline.

Secondary Outcome Measures

Change in Pain Interference

Pain interference is measured by the 4-item PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference scale (PROMIS-PI, 4a). The PROMIS-PI, 4a is a series of 4 questions. Results range from -34 to 34 (t-scores range from 41.6 to 75.6), with higher scores indicating increased pain interference at 24 Weeks compared to Baseline.

Incidence of Any Opioid Use

Incidence of opioid use is measured by a single question, "Are you currently taking any opioid pain medication on a daily basis?" Participants respond with "Yes", "No", or "Not Sure".

Change in Physical Function

Physical function is measured by the PROMIS-PF Short Form 6b. The PROMIS-PF Short Form 6b is a series of 6 questions. Results range from -37.1 to 37.1 (t-scores range from 21.6 to 58.7), with higher scores indicating increased physical functioning at 24 Weeks compared to Baseline.

Change in Depression Score

Depression score is measured by the PROMIS 4-item depression scale from the PROMIS 29 profile. The PROMIS 4-item depression scale from the PROMIS 29 profile is a series of 4 questions. Results range from -38.4 to 38.4 (t-scores range from 41.0 to 79.4), with higher scores indicating increased depression at 24 Weeks compared to Baseline.

Change in Anxiety Score

Anxiety score is measured by the PROMIS Emotional Distress-Anxiety scale (PROMIS-EDA 4a). The PROMIS-EDA 4a is a series of 4 questions. Results range from -41.3 to 41.3 (t-scores range from 40.3 to 81.6), with higher scores indicating increased anxiety at 24 Weeks compared to Baseline.

Change in Sleep Disturbance

Sleep disturbance is measured by the PROMIS short form 6a. The PROMIS short form 6a is a series of 6 questions. Results range from -44.4 to 44.4 (t-scores range from 31.7 to 76.1), with higher scores indicating increased sleep disturbance at 24 Weeks compared to Baseline.

Change in Sleep Duration

Sleep duration is measured by the BACPAC sleep duration question, "During the past month, how many hours and minutes of actual sleep did you get at night? (This may be different than the number of hours and minutes you spent in bed)." Participants respond with a number of hours and minutes. Results range from -24 to 24 hours, with higher number of hours indicating increased sleep duration at 24 Weeks compared to Baseline.

Full Information

NCT ID

NCT05396014

First Posted

May 24, 2022

Last Updated

July 21, 2023

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

1. Study Identification

Unique Protocol Identification Number

NCT05396014

Brief Title

The BEST Trial: Biomarkers for Evaluating Spine Treatments

Acronym

BEST

Official Title

The BEST Trial: Biomarkers for Evaluating Spine Treatments

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 12, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a NIAMS-sponsored clinical trial being conducted through the NIH HEAL Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this trial is to inform a precision medicine approach to the treatment of Chronic Low-Back Pain by estimating an algorithm for optimally assigning treatments based on an individual's phenotypic markers and response to treatment. Interventions being evaluated in this trial are: (1) enhanced self-care (ESC), (2) acceptance and commitment therapy (ACT), (3) evidence-based exercise and manual therapy (EBEM), and (4) duloxetine.

Detailed Description

Each participant will complete an initial screening call and enrollment visit, followed by a 2-week run-in period, two consecutive 12-week treatment periods, and a 12-week post-treatment follow-up period. Upon completion of the run-in period, participant eligibility will be reassessed based on adherence to study protocol. Participants who no longer meet eligibility criteria will be considered screen failures and discontinued from the study. All participants will undergo phenotyping assessments at Visit 0, 1 and 2 corresponding to baseline, the end of the first 12-week intervention period, and the end of the second 12-week intervention period, respectively. A subset of participants will undergo additional phenotyping, consisting of a more comprehensive set of phenotyping assessments, at the same visits. Pain, Enjoyment of Life, and General Activity (PEG) and Patient Global Impressions Scale (PGIC) will be assessed at 6 weeks (midpoint of intervention period one), 12 weeks (Visit 1), 18 weeks (midpoint of intervention period two), 24 weeks (Visit 2), and 36 weeks post-baseline (12 weeks after intervention period two). Basic safety assessments will also be performed at these time points to assess participant tolerability to their current study intervention(s). Patients who are unable to tolerate their assigned study treatment will be educated on how to safely discontinue their current treatment plan but will otherwise remain in the study. The secondary objectives are to (a) estimate Dynamic Treatment Regimes (DTRs) that optimally balance multiple outcomes, taking into account participant preferences for outcomes including pain intensity, pain interference, physical function, opioid use, depression, anxiety, sleep duration and sleep disturbance, (b) estimate DTRs that incorporate additional phenotypic markers (i.e., deep phenotyping) collected on a sub-set of participants, and (c) assess whether effectiveness is sustained based on outcomes collected 24 weeks after randomization to the second treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low-back Pain

Keywords

Pain, Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Sequential Assignment

Model Description

Sequential Multiple Assignment Randomized Trial (SMART)

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

820 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Period 1: Enhanced Self-Care (ESC)

Arm Type

Active Comparator

Arm Description

Arm Title

Treatment Period 1: Acceptance and Commitment Therapy (ACT)

Arm Type

Active Comparator

Arm Description

Arm Title

Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)

Arm Type

Active Comparator

Arm Description

Arm Title

Treatment Period 1: Duloxetine

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Self-Care (ESC)

Intervention Description

The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.

Intervention Type

Behavioral

Intervention Name(s)

Acceptance and Commitment Therapy (ACT)

Intervention Description

ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.

Intervention Type

Behavioral

Intervention Name(s)

Evidence-Based Exercise and Manual Therapy (EBEM)

Intervention Description

Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta

Intervention Description

Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.

Primary Outcome Measure Information:

Title

Change in Patient-Reported Pain Intensity and Interference Score

Description

Time Frame

Baseline, 24 Weeks

Secondary Outcome Measure Information:

Title

Change in Pain Interference

Description

Time Frame

Baseline, 24 Weeks

Title

Incidence of Any Opioid Use

Description

Incidence of opioid use is measured by a single question, "Are you currently taking any opioid pain medication on a daily basis?" Participants respond with "Yes", "No", or "Not Sure".

Time Frame

Baseline, 24 Weeks

Title

Change in Physical Function

Description

Time Frame

Baseline, 24 Weeks

Title

Change in Depression Score

Description

Time Frame

Baseline, 24 Weeks

Title

Change in Anxiety Score

Description

Time Frame

Baseline, 24 Weeks

Title

Change in Sleep Disturbance

Description

Time Frame

Baseline, 24 Weeks

Title

Change in Sleep Duration

Description

Time Frame

Baseline, 24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: To be eligible, an individual must meet all of the following inclusion criteria: Ability to read and understand English Provision of signed and dated informed consent form(s) Willing and able to receive study-related messages and survey links via email Willing and able to receive study-related phone calls Age 18 years old or older Low-back pain for at least 3 months and occurring on at least half the days in the past 6 months Contraindicated to no more than one of the study interventions at the time of eligibility assessment(s) Eligible to receive at least three of the four study interventions and willing to receive any intervention for which they are eligible A PEG score 4 or higher prior to the Run-in period Willing and able to undergo required phenotyping Regular reliable access to an internet-enabled device such as a smart phone, tablet, or laptop computer Meet Run-in period engagement eligibility criteria: o Completion of two Run-in study information modules prior to period 1 randomization (Visit 0) Low-back pain more severe than pain in other parts of the body Available to complete the full study protocol (approximately 9 months) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Pregnant at the time of Visit 0 (Baseline) Affirmative participant response to any of the following conditions: Progressive neurodegenerative disease History of discitis osteomyelitis (spine infection) or spine tumor History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength <4/5 on manual motor testing) Diagnosis of any vertebral fracture in the last 6 months Osteoporosis requiring pharmacologic treatment other than vitamin D, calcium supplements, or bisphosphonates. History of any bone-related cancer or cancer that metastasized to the bone Currently in treatment for any non-skin cancer or plan to start non-skin cancer treatment in the next 12 months History of any non-skin cancer treatment in the last 24 months Visual or hearing difficulties that would preclude participation Uncontrolled drug/alcohol addiction Individuals actively pursuing disability or workers compensation or involved in active personal injury-related litigation Currently participating in another interventional pain study Any condition that, in the opinion of the investigator, would preclude the patient from being able to safely participate in in the trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Goolsby

Phone

919-843-0685

rwgoolsby@unc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mirela Scott

Phone

919-962-3029

mscott4@email.unc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin Anstrom, PhD

Organizational Affiliation

UNC Chapel Hill

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anna Hoffmeyer, MPH

Organizational Affiliation

UNC Chapel Hill

Official's Role

Study Director

Facility Information:

Facility Name

Stanford University

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Safa Sohail

sasohail@stanford.edu

First Name & Middle Initial & Last Name & Degree

Sean Mackey, MD, PhD

First Name & Middle Initial & Last Name & Degree

Kristen Slater, PsyD

First Name & Middle Initial & Last Name & Degree

Vafi Salmasi, MD

Facility Name

University of California, San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92037

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Phirum Nguyen

psnguyen@health.ucsd.edu

First Name & Middle Initial & Last Name & Degree

Mark Wallace, MD

First Name & Middle Initial & Last Name & Degree

Joel Castellanos, MD

First Name & Middle Initial & Last Name & Degree

Fadel Zeidan, PhD

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jen Johnson

beststudy@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Jeffrey Lotz, PhD

First Name & Middle Initial & Last Name & Degree

Conor O'Neill, MD

First Name & Middle Initial & Last Name & Degree

Patricia Zheng, MD

First Name & Middle Initial & Last Name & Degree

Trisha Hue, PhD, MPH

First Name & Middle Initial & Last Name & Degree

Roland Krug, PhD

First Name & Middle Initial & Last Name & Degree

An Vu, PhD

Facility Name

University of Kansas Health System

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miranda McMillan

facelab@kumc.edu

First Name & Middle Initial & Last Name & Degree

Andrea Chadwick, MD

First Name & Middle Initial & Last Name & Degree

Lora Black, PhD, MPH

First Name & Middle Initial & Last Name & Degree

Neena Sharma, PhD, PT, CMPT

Facility Name

Massachusetts General Hospital/Brigham Women's Hospital, Harvard Medical School

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niayesh Mardmomen

nmardmomen@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Jianren Mao, MD

First Name & Middle Initial & Last Name & Degree

Lucy Chen, MD

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48189

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joseph Long

beststudy@med.umich.edu

First Name & Middle Initial & Last Name & Degree

Afton Hassett, PsyD

Facility Name

University of North Carolina Hospital Pain Management Clinic

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernice Asante-Nketiah

uncbesttrial@unc.edu

First Name & Middle Initial & Last Name & Degree

Matt Mauck, MD, PhD

First Name & Middle Initial & Last Name & Degree

Brooke Chidgey, MD

Facility Name

Atrium Health Wake Forest Baptist

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27517

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lynnette Harris

bacpac@wakehealth.edu

First Name & Middle Initial & Last Name & Degree

Robert Hurley, MD, PhD

First Name & Middle Initial & Last Name & Degree

Amber Brooks, MD

Facility Name

The Ohio State University Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43203

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lindsay Hanes

lindsay.hanes@osumc.edu

First Name & Middle Initial & Last Name & Degree

Tristan Weaver, MD

First Name & Middle Initial & Last Name & Degree

William Marras, PhD, CPE

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tamara Artman

tamara.artman@pitt.edu

First Name & Middle Initial & Last Name & Degree

Gwendolyn Sowa, MD, PhD

First Name & Middle Initial & Last Name & Degree

Ajay Wasan, MD

First Name & Middle Initial & Last Name & Degree

Sara Piva, PT, PhD

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haley Schiek

schiek@musc.edu

First Name & Middle Initial & Last Name & Degree

Kelly Barth, DO

First Name & Middle Initial & Last Name & Degree

Jeffrey Borckardt, PhD

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brianna Zhou

besttrial@uw.edu

First Name & Middle Initial & Last Name & Degree

Sean Rundell, PT, DPT, PhD

First Name & Middle Initial & Last Name & Degree

Kushang Patel, PhD, MPH

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All relevant study data will be shared through NIH portals as required.

IPD Sharing Time Frame

Data will be made publicly available on the NIH HEAL Platform or other NIH repositories after acceptance of publication for the primary results per NIH HEAL Data Sharing Policy and will remain available for a minimum of 10 years.

IPD Sharing Access Criteria

BACPAC Data Access and Publications Policy: https://sites.cscc.unc.edu/cscc/sites/default/files/bacpac/qxq/BACPAC_Data_Access_and_Publications_Policy.pdf Data from this study may be requested by other researchers by using the HEAL Data Platform: https://heal.nih.gov/data/heal-data-ecosystem

IPD Sharing URL

https://heal.nih.gov/data/public-access-data

Learn more about this trial

The BEST Trial: Biomarkers for Evaluating Spine Treatments

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