Options for Pain Management Using Nonpharmacological Strategies (OPTIONS)

Options for Pain Management Using Nonpharmacological Strategies (OPTIONS)

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.

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Behavioral: Options for Pain Management using Non-medication Strategies

Detailed Description

Non-pharmacological treatments (NPTs) for chronic pain are safe, effective, and widely available in VA. In response to the widespread harms associated with opioids and high-quality evidence supporting NPTs for chronic pain the Centers for Disease Control, American College of Physicians, Department of Defense, and Veterans Health Administration (VHA) released guidelines or adopted policies to move away from opioids toward multimodal approaches that prioritize evidence-based nonpharmacological pain treatments (NPTs) NPTs include both traditional (e.g., cognitive behavioral therapy, exercise/movement) and complementary/integrative health (CIH) (e.g., acupuncture, yoga) approaches. VA has been a leader in expanding access to these approaches, and in 2016 the Comprehensive Addiction and Recovery Act mandated that VA expand availability of CIH therapies. A survey published in 2021 revealed that this expansion has been successful. VA medical centers offered an average of 5 CIH approaches, with 63 sites offering at least 10. Expansion of CIH therapies has also been one of three key components of VA's Whole Health Initiative, implemented by VA's Office of Patient-Centered Care and Cultural Transformation (one of the investigators' operational partners). In addition, as a result of implementation in 2012, cognitive-behavioral therapy for chronic pain is available at 92% of VAs. Consequently, NPTs are widely available across VA.

Despite these efforts, pain remains a significant problem among Veterans. In 2017, 66% of Veterans reported pain, with 9% reporting severe pain. Compared to non-Veterans, Veterans had 1.5 times the odds of having severe pain, and Veterans aged 18-39 had 3 times the odds of having severe pain compared to non-Veterans of the same age. A survey of over 9,000 Veterans with pain, published in 2020, revealed that Veterans continue to report high pain levels. Veterans reported a past-week mean pain severity of 6.75 on a 0-10 scale and a mean of 6.8 different pain locations. Over half (56%) of Veterans reported the effectiveness of the Veterans' pain treatment as fair to poor, with only 12% rating the Veterans' pain treatment as very good or excellent. Continued opioid-related harms, high levels of Veteran-reported pain, and low satisfaction with pain care indicate that, despite VA efforts to improve pain management, additional efforts are needed to help Veterans effectively manage chronic pain using safe, evidence-based approaches.

• Study Type: Interventional
• Enrollment (Estimated): 296
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne S Matthias, PhD MS BA; Email: msmatthias@arizona.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202-2884
      • Recruiting
      • Richard L. Roudebush VA Medical Center, Indianapolis, IN
      • Principal Investigator: Matthew J. Bair, MD MS
      • Contact: Angela L Rollins, PhD MS; Phone Number: (317) 771-4023; Email: Angela.Rollins@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.; Other Names: OPTIONS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Nonpharmacological and Self-Care Approaches (NSCAP)	This measure was developed by members of the VA/DoD/NIH Pain Management Collaboratory, which is comprised of national experts in NPTs and is led by Dr. Robert Kerns of the VA PRIME Center. The NSCAP asks about use of 9 Non-pharmacological treatments , including the 6 included in the OPTIONS Decision Aid, and assesses details of use such as frequency and patients' judgments of effectiveness. Space is provided for additional Non-pharmacological treatments patients may be using.	Change from baseline to 6 months
Patient Activation Measure (PAM)	Patient activation will be measured with the 13-item Patient Activation Measure (PAM) Short Form, which assesses patient knowledge, skill, and confidence for self-management of one's chronic health condition. The PAM has good reliability ( =.87-.88) and validity in many studies, including our own.	Change from baseline to 6 months
VR-12	Health-related quality of life will be measured with the VR-12, a modified version of the Medical Outcomes Study SF-12. Internal consistency is high, ranging from =.87-.96.73	Change from baseline to 6 months
Depression PHQ-8	Depression will be measured with the widely-used 8-item PHQ-8	Change from baseline to 6 months
Anxiety GAD-7	Anxiety will be measured with the GAD-7, which has strong psychometric properties.	Change from baseline to 6 months
Pain catastrophizing	Pain catastrophizing will be measured with the 13-item Pain Catastrophizing Scale, which is a strong predictor of treatment response and has strong psychometric properties.	Change from baseline to 6 months
Decisional Conflict Scale	The decisional conflict scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty; and c) effective decision making.	Change from baseline to 6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Matthew J. Bair, MD MS, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Pain management; Self management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain; Agnosia
• Other Study ID Numbers: SDR 21-012; 15351 (Other Identifier: Indiana University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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