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Behavioral Intervention
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
OPTIONS Trial 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.Check my eligibility
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.See study design
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.
OPTIONS Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
Anxiety
Decisional Conflict Scale
Depression PHQ-8
+4 moreOPTIONS 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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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,133 Total Patients Enrolled
20 Trials studying Pain
4,728 Patients Enrolled for Pain
Marianne Sassi Matthias, PhD MS BAPrincipal InvestigatorRichard L. Roudebush VA Medical Center, Indianapolis, IN
3 Previous Clinical Trials
485 Total Patients Enrolled
2 Trials studying Pain
465 Patients Enrolled for Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term opioid medication.I have had pain in my back, neck, or limbs for at least 3 months.I experience moderate pain that affects my daily activities.I have a doctor's appointment scheduled within the next three months.I have a severe problem with hearing or speaking.I am open to trying new treatments for pain.I do not have severe heart issues or other serious health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: OPTIONS Intervention Coaching
- Group 2: OPTIONS Waitlist Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers being taken for this experiment yet?
"According to clinicaltrials.gov, recruitment for this medical trial is underway; the post was originally published on November 1st 2022 and has recently been modified on November 30th 2022."
Answered by AI
What is the projected capacity of this research program?
"Affirmative. Clinicaltrials.gov confirms that this medical research, which was first published on November 1st 2022, is actively recruiting participants. A total of 296 people must be enlisted from one location."
Answered by AI
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