The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrooke Army Medical Center
About this trial
The goal of this study is to improve pain care in the MHS by identifying effective, whole-person, non-pharmacologic interventions for persons with chronic musculoskeletal pain. The investigators will evaluate two promising, evidence-based holistic health interventions and compare them to usual care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
TRICARE Beneficiary
Meets the case definition of chronic MSK pain requiring 2 or more medical encounters within the past year and at least 90 days apart for the same MSK condition indicated by medical encounter data or MSK pain ICD-10 codes in the electronic medical record
Disqualifiers
Actively receiving cancer treatment
Currently known to be pregnant
Receiving advanced chronic pain management, including multi-disciplinary or behavioral pain management or mental health or substance use programs (beyond the initial step of the VA/DoD stepped care model for pain management)
Suicidal Ideation determined by a higher than lower risk score on the P4 Screener
Trial design
Design model
Parallel
Treatments tested in this trial
Empowered Relief
BehavioralER is provided in a single, 2-hour session delivered remotely by trained instructors. ER has two main components: didactics and skills acquisition as outlined below. The ER class is administered virtually. The class includes the didactic and skill acquisition content. At the end of the class participants receive tangible items including the self-crafted, personalized catastrophizing cessation plan, a guided relaxation response audio file, and an electronic copy of the didactic class content.
Move to Health
BehavioralThe M2H intervention is delivered virtually by trained health coaches using a 6-step process. The administration of M2H begins with an initial session with follow-up sessions scheduled every 1-2 weeks for up to 8 weeks or until the participant is ready to transition to self-management.
Usual Care as determined by primary care provider
Other interventionPatients will receive care as determined by their primary care provider, with no input or control by the research team.
Treatment groups
608 Participants
are divided into 3 treatment groupsGroup A: Empowered ReliefActive comparator 1 intervention
Group B: Move to HealthActive comparator 1 intervention
Group C: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
3-PEG Scale
The three items include 1 pain intensity item (Pain intensity during the past week) and 2 pain interference items (Pain interference with Enjoyment of life, and pain interference with General activity). The total score is the average of the three items (range, 0-10; higher scores indicate worse pain impact)
Time frame
From enrollment to the end of treatment at 14 weeksSecondary outcomes
1
PROMIS Physical Function
The PROMIS short form 6b for physical function uses fixed items from the PROMIS physical function item bank to provide a T-score with population mean = 50 (sd=10).96
Time frame
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)2
PROMIS Sleep Disturbance
The PROMIS short form 6a for sleep disturbance uses fixed items from the PROMIS sleep disturbance item bank to provide a T-score with population mean = 50 (sd=10).
Time frame
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)3
3-PEG Scale
The three items include 1 pain intensity item (Pain intensity during the past week) and 2 pain interference items (Pain interference with Enjoyment of life, and pain interference with General activity). The total score is the average of the three items (range, 0-10; higher scores indicate worse pain impact)
Time frame
From enrollment to the end of the surveillance period (26 and 52 weeks)4
PROMIS Depression
The PROMIS short form 6a for depression uses fixed items from the PROMIS depression item bank to provide a T-score with population mean = 50 (sd=10).
Time frame
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brooke Army Medical Center
Lead sponsor
59th Medical Wing
Collaborator
Desmond Doss Health Clinic, Schofield Barracks
Collaborator
University of Utah
Collaborator
Madigan Army Medical Center
Collaborator
Bassett Army Community Hospital
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov