Non-Medication Pain Management Strategies for Chronic Pain

(OPTIONS Trial)

Overseen By Marianne S Matthias, PhD MS BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Opioids

Disqualifiers: Psychiatric hospitalization, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 9 months

296 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different ways for Veterans to manage chronic pain without medication. Participants work with a coach to identify personal values and goals, finding non-medication strategies that align with them. The study suits Veterans who have experienced musculoskeletal pain in areas like the low back, neck, or joints for at least three months and are open to new treatment approaches. Participants receive support to overcome any barriers in using these new strategies and prepare to discuss them with their primary care providers. As an unphased trial, this study offers Veterans the chance to explore innovative pain management strategies tailored to their personal needs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on non-medication strategies, so you might be able to continue your current meds while participating.

What prior data suggests that these non-medication pain management strategies are safe?

Research has shown that non-drug methods for managing chronic pain are generally safe. Studies have found no serious risks associated with these methods, which include exercise, mind-body practices, and psychological therapies. Most people tolerate them well.

These strategies help manage pain without medication, aiming to enhance overall well-being and quality of life. Participants often collaborate with a coach to tailor these methods to their personal values and goals, offering a flexible choice for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the non-medication pain management strategies trial because it emphasizes personalized coaching to align patients' values and goals with their treatment plans. Unlike standard treatments for chronic pain, which often rely on medications like NSAIDs or opioids, this approach uses motivational interviewing and a decision aid to empower patients in managing their pain without drugs. By focusing on overcoming barriers and enhancing communication with healthcare providers, this method aims to provide a sustainable, holistic alternative to traditional pain management options.

What evidence suggests that these non-medication strategies are effective for managing chronic pain?

A previous study showed that treatments not involving medication, such as exercise, mind-body practices, and psychological therapies, help with chronic pain. Research indicates these methods can reduce pain and improve daily functioning. For instance, mindfulness and acupuncture have relieved pain and enhanced quality of life. Cognitive-behavioral therapy (CBT) has also proven effective, helping individuals manage pain and feel more confident in handling it. Overall, these non-medication strategies offer promising results for managing chronic pain without drugs.

In this trial, participants in the OPTIONS Intervention Coaching arm will engage in coaching sessions to explore and implement these non-medication strategies. Those in the OPTIONS Waitlist Control arm will receive the intervention decision aid after completing the study. ^{1 2 4 5 6}

Who Is on the Research Team?

Matthew J. Bair, MD MS

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

A psychiatric hospitalization in the past 6 months

Eligibility screener reveals active suicidal ideation

Eligibility screener reveals cognitive impairment, defined by a score of >3 on MMSE cognitive screen

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a series of four coaching sessions focused on nonpharmacological pain management strategies

9 months

4 coaching sessions

Follow-up

Participants are monitored for changes in patient activation, quality of life, depression, pain interference, pain catastrophizing, use of nonpharmacological approaches, anxiety, and decisional conflict

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Options for Pain Management using Non-medication Strategies

Trial Overview

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.

How Is the Trial Designed?

Group I: OPTIONS Intervention Coaching Experimental Treatment 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Non-pharmacological methods for managing acute pain, such as psychological approaches (like relaxation training and distraction) and complementary therapies (like massage and acupuncture), have a solid research foundation supporting their effectiveness.

While many established non-pharmacological techniques show promise in acute pain management, some methods, like hypnosis and aromatherapy, require further research to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacological aspects of acute pain management. Stevensen, C.[2019]

Nonpharmacologic interventions for pain management can effectively reduce pain and have minimal adverse effects, making them a valuable option for patients.

These interventions empower patients to take an active role in their own care, highlighting the important role of nurses in implementing these strategies to improve pain management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic interventions for pain management. Doody, SB., Smith, C., Webb, J.[2018]

Complementary therapies like acupuncture, massage, mind-body interventions, and music therapy are safe and noninvasive options that can effectively reduce pain and improve quality of life for patients.

These therapies can be used alongside standard pain management techniques to enhance treatment outcomes and potentially decrease reliance on prescription medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary therapies for cancer pain. Cassileth, B., Trevisan, C., Gubili, J.[2019]

A survey of adults with chronic pain in the UK revealed that various pain management strategies, including physical therapy, exercise, and psychological therapy, are commonly used, indicating a trend towards multi-faceted care.

Despite the NICE guidelines recommending reduced use of opioids, 47% of participants still reported using these medications, highlighting a slow adoption of the guidelines and a need for improved care provision in pharmacological management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 2021 NICE guidelines for assessment and management of chronic pain: A cross-sectional study mapping against a sample of 1,000* in the community. Zambelli, Z., Halstead, EJ., Iles, R., et al.[2022]

Chronic pain treatment should combine both pharmacological and nonpharmacological methods, including options like physical therapy, acupuncture, and music therapy.

While the evidence for the effectiveness of these nonpharmacological treatments is often inconsistent, they can still be beneficial and should be tailored to meet individual patient needs for improved well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nonpharmacological pain therapy for chronic pain]. Drebenstedt, C.[2019]

Chronic pain management requires a multidisciplinary approach, as it is influenced by various factors, necessitating careful diagnosis and assessment to tailor treatment effectively.

Pain Clinics that offer a comprehensive range of treatments—including medications, surgical options, stimulation techniques, and psychological support—can significantly improve pain relief and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain clinics and pain clinic treatments. Wells, JC., Miles, JB.[2019]

Non-pharmacological therapies are important for managing chronic pain and are valued by both patients and caregivers.

To ensure the safe implementation of these therapies, appropriate regulatory guidelines and specific training for caregivers are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The non-pharmacological management of chronic pain]. Berlemont, C.[2017]

Nonpharmacological approaches to pain management during labor and delivery, such as massage, breathing techniques, and cognitive therapies, are effective and should be included in the care and counseling of women, as they utilize the body's natural resources to manage pain.

The review of evidence from various studies indicates that these methods can reduce the need for medical interventions, promoting a better understanding of the physiological processes of stress and pain during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No. 355-Physiologic Basis of Pain in Labour and Delivery: An Evidence-Based Approach to its Management. Bonapace, J., Gagné, GP., Chaillet, N., et al.[2022]

Nonpharmacologic interventions can effectively reduce pain in critical care settings, but they should complement, not replace, traditional medication-based pain management.

There is a need for more research to identify the most effective nonpharmacologic pain treatments and the specific conditions in which they work best, as current studies show varied methods and results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic treatment of pain. Titler, MG., Rakel, BA.[2022]

Effective chronic pain management starts with counseling patients to set realistic goals for pain relief, emphasizing improvement in functionality and quality of life rather than complete pain elimination.

Engaging patients in their own pain management and considering multidisciplinary approaches can enhance treatment outcomes and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid crisis renews interest in osteopathic manipulation. Johnson, SR.[2019]

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