Clinical trial NCT05563792: Options for Pain Management Using Nonpharmacological Strategies
Official title: Options for Pain Management Using Nonpharmacological Strategies (OPTIONS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Keywords: Chronic Pain
Self management
Pain management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-10-03
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized control trial with behavioral intervention
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Interference Brief Pain Inventory (BPI)
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Use of Nonpharmacological and Self-Care Approaches (NSCAP)
timeFrame: Change from baseline to 6 months
measure: Patient Activation Measure (PAM)
timeFrame: Change from baseline to 6 months
measure: VR-12
timeFrame: Change from baseline to 6 months
measure: Depression PHQ-8
timeFrame: Change from baseline to 6 months
measure: Anxiety GAD-7
timeFrame: Change from baseline to 6 months
measure: Pain catastrophizing
timeFrame: Change from baseline to 6 months
measure: Decisional Conflict Scale
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Marianne Sassi Matthias, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References: