Nonpharmacologic Strategies for Chronic Pain

(INSPIRE Trial)

Recruiting at 1 trial location

Overseen By Jason Satterfield, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Severe mental illness, others

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

Compensation: Varies

Number of Visits: Unknown

586 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to manage chronic pain without medication through a mobile app and telehealth coaching. The app provides tools such as cognitive-behavioral therapy, physical therapy, and mindfulness exercises, while regular telehealth visits offer personalized guidance. Participants will be randomly assigned to either use the app and coaching or receive educational materials about pain. Individuals who have experienced chronic pain for at least three months and speak English, Spanish, or Cantonese may be suitable if they are willing to use a smartphone and participate for a year. As an unphased trial, this study presents a unique opportunity to investigate innovative pain management techniques without medication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-drug strategies for managing pain, so it's possible you can continue your current medications, but you should confirm with the study team.

What prior data suggests that this app and telehealth coaching program are safe for managing chronic pain?

Research shows that non-drug methods for managing pain, such as those in the INSPIRE program, are generally safe. These methods include cognitive-behavioral therapy (a type of talk therapy), physical therapy, and mindfulness practices like meditation. Studies have found that these approaches are usually well-tolerated and lack the side effects associated with medications.

The Centers for Disease Control and Prevention (CDC) recommend non-drug treatments as the first step for managing chronic pain due to their typically low risk. Although evidence on the effectiveness of some non-drug techniques in reducing chronic pain is limited, they remain a safer option compared to many medications.

In summary, while non-drug pain management strategies are generally safe, their effectiveness can vary. Most people tolerate these treatments well without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the nonpharmacologic strategies for chronic pain because they offer a fresh approach compared to traditional treatments like medications and invasive procedures. This new method utilizes a smartphone app that tailors a self-management program, combining cognitive-behavioral therapy, physical therapy, and mindfulness-based interventions right at the user's fingertips. Additionally, it includes weekly telehealth sessions with a pain coach who uses real-time data to personalize care, enhancing the primary care experience through integrated electronic health records. These features could lead to more personalized, convenient, and holistic pain management, potentially improving outcomes for individuals suffering from chronic pain.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that the INSPIRE chronic pain management system, available to participants in this trial, might reduce pain and opioid use. Studies have found that methods like cognitive-behavioral therapy (CBT), physical therapy (PT), and mindfulness effectively manage chronic pain. These approaches aim to enhance overall well-being and reduce reliance on pain medication. Early results suggest that combining these strategies with telehealth coaching and an app provides personalized support for diverse communities. This system emphasizes customized care, potentially leading to improved pain management outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Jason Satterfield, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals from Black, Chinese, and Latinx communities in the San Francisco Bay Area who are experiencing chronic pain. Participants should be comfortable using a mobile app and telehealth coaching program.

Inclusion Criteria

I am willing to join a 12-month study for managing chronic pain.

I am willing to use a smartphone for the study.

Have a UCSF Health or SFHN PCP

Exclusion Criteria

Severe mental illness or other condition preventing informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Testing

Development and testing of the trilingual mobile app and telehealth coaching program with a brief single arm pilot

2 years

Randomized Controlled Trial (RCT)

Full two arm RCT to evaluate changes in PEG scores and secondary outcomes

12 months

Weekly telehealth visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Integrating Nonpharmacologic Strategies for Pain

Trial Overview The INSPIRE study is testing a new trilingual mobile app alongside telehealth coaching to manage chronic pain without medication. It starts with an initial pilot phase followed by a full randomized controlled trial comparing changes in pain experiences.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The INSPIRE chronic pain management system has three primary components: 1) a patient facing smartphone app that collects and interprets a comprehensive intake and patient reported outcomes (PROs), provides health education, and a tailored, modular self-management program that includes cognitive-behavioral therapy (CBT), physical therapy (PT), and mindfulness-based interventions (MBI), 2) a weekly telehealth visit with a pain coach that uses the PRO data and module engagement measures to guide the visit, and 3) enhanced primary care coordination achieved through pain coaching notes and alerts integrated into the electronic health record (EHR).

Group II: Control Active Control 1 Intervention

Control participants will receive educational materials about chronic pain and full workbook with non-pharmacologic strategies.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

An interdisciplinary model for pain management was developed within an integrated health care system, focusing on improving outcomes across various care settings, including acute care and home care.

The model established four key clinical indicators to measure pain management effectiveness, emphasizing strategies like staff accountability and patient education to enhance overall care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Road to excellence in pain management: research, outcomes and direction (ROAD). Vega-Stromberg, T., Holmes, SB., Gorski, LA., et al.[2019]

A systematic review of nonpharmacologic pain treatment trials revealed significant inadequacies in adverse event (AE) reporting, with less than half of the trials detailing specific AE assessment methods.

AE reporting was more comprehensive in trials involving patients compared to those with healthy volunteers, indicating a need for improved adherence to reporting guidelines across all types of trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review. Hunsinger, M., Smith, SM., Rothstein, D., et al.[2018]

A review of 91 cases of injection therapies for chronic pain revealed that 58% of patients experienced health care-related harm, often due to complications like neurologic symptoms, injury, and infection.

The study identified significant issues in clinical care, with 74% of cases criticized by peer experts, highlighting provider-related factors such as poor decision-making and failure to follow procedures, as well as team-related issues like inadequate medical record keeping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from examination of Canadian medico-legal cases related to interventional therapies for chronic pain management. MacLean, E., Garber, G., Barbosa, K., et al.[2023]

A systematic review of 80 randomized controlled trials (RCTs) on noninvasive analgesic treatments revealed that adverse event (AE) reporting was often incomplete, with over 40% of trials not reporting any serious adverse events.

The review highlighted that trials involving participants with pain conditions and those sponsored by industry provided better AE data, indicating a need for improved consistency and thoroughness in AE reporting across all analgesic RCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. Smith, SM., Wang, AT., Katz, NP., et al.[2023]

Citations

1. pcori.org pcori.org/research-results/2017/does-motivational-interviewing-plus-cognitive-behavioral-therapy-reduce-opioid-use-among-adults-chronic-pain-better-shared-decision-making-inspire-study

The INSPIRE Study This pragmatic randomized controlled trial compared the effectiveness of two behavioral interventions in reducing opioid dosages and pain ...

2. rti.org rti.org/impact/inspire-trial-managing-long-term-pain

INSPIRE Trial: Chronic Pain Management Comparison The INSPIRE Trial compares two approaches to managing chronic pain and reducing long-term opioid use, aiming to improve patient well-being.

3. icpsr.umich.edu icpsr.umich.edu/web/pcodr/studies/39271

Integrated Health Services to Reduce Opioid Use While ... INtegrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) was a pragmatic randomized trial conducted from 2019 to 2023 ...

4. heal.nih.gov heal.nih.gov/funding/awarded?rfa=All&research_program=All&institutions1=&locations1=&goal=All&combine=&grant=All&locations=&institutions=&items_per_page=5&select_location=All&year=&page=30&order=field_locations&sort=desc

Funded Projects | NIH HEAL Initiative The Integrating Nonpharmacologic Strategies for Pain with Inclusion, Respect, and Equity (INSPIRE) Chronic Pain (CP) intervention blends cognitive ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06183281

Integrating Nonpharmacologic Strategies for Pain With ... INSPIRE creates a trilingual mobile app and telehealth coaching program to promote non-pharmacologic strategies for pain management with Black, Chinese, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11866493/

An update on non-pharmacological interventions for pain relief In conclusion, there is weak evidence for the efficacy of noninvasive neuromodulatory techniques in decreasing chronic pain. The relatively similar efficacy of ...

7. heal.nih.gov heal.nih.gov/funding/awarded?combine=&goal=All&grant=All&institutions=&institutions1=&items_per_page=25&locations=&locations1=&research_program=42106&rfa=All&select_location=All&year=&order=title&sort=desc

Funded Projects | NIH HEAL Initiative The Integrating Nonpharmacologic Strategies for Pain with Inclusion, Respect, and Equity (INSPIRE) Chronic Pain (CP) intervention blends ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2793231

Nonopioid Treatments for Chronic Pain The CDC guideline attempts to address this issue by recommending nonopioid medication and nonpharmacologic pain management as first-line treatments for chronic ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1550830718300223

Evidence-Based Nonpharmacologic Strategies for ... Therapies reviewed include acupuncture therapy, massage therapy, osteopathic and chiropractic manipulation, meditative movement therapies Tai chi and yoga.