Options for Pain Management Using Nonpharmacological Strategies

Pain Clinical Trial

— OPTIONS  

Official title:

Options for Pain Management Using Nonpharmacological Strategies (OPTIONS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563792
• Other study ID #: SDR 21-012
• Secondary ID: 15351
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 31, 2026

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Marianne S Matthias, PhD MS BA
• Phone: (317) 988-4514
• Email: marianne.matthias[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: October 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Depression PHQ-8	Depression will be measured with the widely-used 8-item PHQ-8	Change from baseline to 6 months
Secondary	Anxiety GAD-7	Anxiety will be measured with the GAD-7, which has strong psychometric properties.	Change from baseline to 6 months
Secondary	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
Secondary	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