Non-Medication Pain Management Strategies for Chronic Pain (OPTIONS Trial)

N/A

Recruiting

Led By Marianne Sassi Matthias, PhD MS BA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial teaches Veterans how to manage chronic pain without medications, with a coach to help explore their values and goals.

Who is the study for?

This trial is for Veterans with chronic musculoskeletal pain in the low back, neck, or limbs lasting at least 3 months. Participants should be open to non-medication treatments and have moderate pain affecting their life. They must not have severe cognitive issues, active suicidal thoughts, long-term opioid use, recent psychiatric hospitalization, or serious medical conditions like advanced heart failure.

What is being tested?

The study explores nonpharmacological strategies for managing chronic pain among Veterans. It involves working with a coach to align various non-medication approaches with the participants' values and goals in relation to their chronic pain management.

What are the potential side effects?

Since this trial focuses on nonpharmacological methods of managing pain (like physical therapy or mindfulness), it does not involve medication; therefore, typical drug side effects are not expected. However, some discomfort may arise from trying new activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Secondary study objectives

Anxiety

Decisional Conflict Scale

Depression PHQ-8

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OPTIONS Intervention CoachingExperimental Treatment1 Intervention

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.

Group II: OPTIONS Waitlist ControlActive Control1 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.

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