Options for Pain Management Using Nonpharmacological Strategies

NCT05563792 | Recruiting

• 2 other identifiers: SDR 21-01215351
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Pain; Self management; Pain management

Outcome Measures

Primary Outcomes (1)

• Pain Interference Brief Pain Inventory (BPI)

  The pain interference score from the Brief Pain Inventory averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Lower scores are better outcomes.

  Change from baseline to 6 months

Secondary Outcomes (7)

• Use of Nonpharmacological and Self-Care Approaches (NSCAP)

  Change from baseline to 6 months

• Patient Activation Measure (PAM)

  Change from baseline to 6 months

• VR-12

  Change from baseline to 6 months

• Depression PHQ-8

  Change from baseline to 6 months

• Anxiety GAD-7

  Change from baseline to 6 months

Study Arms (2)

OPTIONS Intervention Coaching

EXPERIMENTAL

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.

Behavioral: Options for Pain Management using Non-medication Strategies

OPTIONS Waitlist Control

NO INTERVENTION

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 BEHAVIORAL

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.

Also known as: OPTIONS

OPTIONS Intervention Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

RECRUITING

MeSH Terms

Conditions

Pain; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Matthew J. Bair, MD MS

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne S Matthias, PhD MS BA

CONTACT

msmatthias@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will be blinded to the treatment assignment when administering baseline outcome assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: A randomized control trial with behavioral intervention

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 3, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)