Recruiting

Pain Management

Sponsor:

VA Office of Research and Development

Code:

NCT05563792

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Options for Pain Management using Non-medication Strategies

Study Details

Brief summary:

The purpose of this study is to help Veterans learn about different ways they can manage chronic pain that do not involve medications. Veterans will work with a coach to explore the Veterans' values and goals and how different non-medication approaches may fit into these values and goals.

Conditions

Pain

Study ID

NCT05563792

Start date

Nov 1, 2022

Status verified date

Oct, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for at least 3 months
  • have at least moderate pain intensity and interference with function, defined by a score of 4 (possible range: 0-10) on the PEG, a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity (obtained from phone screener)
  • have a primary care appointment scheduled or due in approximately the next three months
  • open to trying new pain treatments

Exclusion Criteria:

  • a psychiatric hospitalization in the past 6 months
  • long-term opioid therapy
  • severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure) which includes heart attack, stroke, and cancer, or
  • if the eligibility screener reveals cognitive impairment, defined by a score of >3 (possible range: 0-6) on MMSE cognitive screen (obtained from phone screener), or
  • if the eligibility screener reveals active suicidal ideation, or
  • severe hearing/speech impairment

Study Design

Enrollment

296 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OPTIONS Intervention Coaching

Intervention participants will participate in a series of four coaching sessions focused on helping patients clarify their values and treatment goals, aligning these values and goals and their lifestyle with nonpharmacological treatment options, working on overcoming barriers to use and adherence of nonpharmacological treatment options (using motivational interviewing), and preparing patients to discuss these options with their primary care providers. A decision aid will be used during these coaching sessions.

no intervention: OPTIONS Waitlist Control

Participants randomized into waitlist control group will receive the intervention decision aid after completing the last survey at 9 months. Participants will also be offered the opportunity to have a brief 20-minute session with a member of the OPTIONS study staff to help walk them through this decision aid.

Interventions

Options for Pain Management using Non-medication Strategies

The purpose of this study is to help Veterans learn about different ways they can manage chronic pain that do not involve medications. Veterans will work with a coach to explore their values and goals and how different non-medication approaches may fit into these values and goals.

Primary outcome measure

  • Pain Interference Brief Pain Inventory (BPI) [ Time Frame: Change from baseline to 6 months ]

Central Contacts and Locations

Central contacts

Marianne S Matthias, PhD MS BA

(520) 626-6154msmatthias@arizona.edu

Locations

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Recruiting

Indianapolis, Indiana, United States, 46202-2884

Contacts

Angela L Rollins, PhD MS

(317) 771-4023Angela.Rollins@va.gov

Principal Investigator:

Matthew J. Bair, MD MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • Chronic Pain
  • Self management
  • Pain management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.