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

Trial Summary

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 data supports the effectiveness of the treatment Integrating Nonpharmacologic Strategies for Pain?

Research shows that non-drug treatments for chronic pain, like cognitive behavioral interventions, can be cost-effective and help reduce pain and improve how well patients function. Additionally, patients using non-drug strategies often find them helpful in managing their pain. ^{1 2 3 4 5}

Is the treatment of nonpharmacologic strategies for chronic pain generally safe for humans?

The safety data for nonpharmacologic strategies for chronic pain is not well-documented, as many clinical trials do not adequately report adverse events (unwanted effects). However, these treatments are generally considered safe, though specific safety information is often incomplete or inconsistent. ^{6 7 8 9 10}

How does the treatment Integrating Nonpharmacologic Strategies for Pain differ from other treatments for chronic pain?

This treatment is unique because it combines various non-drug approaches like relaxation, meditation, cognitive behavioral therapy, and exercise to manage chronic pain, focusing on improving quality of life and function rather than just reducing pain. It offers a holistic approach that addresses both physical and psychological aspects of pain, potentially reducing the need for pain medications. ^{2 11 12 13 14}

What is the purpose of this trial?

INSPIRE creates a trilingual mobile app and telehealth coaching program to promote non-pharmacologic strategies for pain management with Black, Chinese, and Latinx communities in the San Francisco Bay Area. Years 1-2 will develop the app and test it with a brief single arm pilot starting in Nov 2023. A full two arm randomized controlled trial (RCT) will being in early 2025 with changes in PEG scores as the primary outcome. Secondary outcomes include Helping to End Addiction Longterm (HEAL) common data elements.

Research Team

Jason Satterfield, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Exploring patient experiences of a pain management centre: A qualitative study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Economic Evaluation: A Randomized Pragmatic Trial of a Primary Care-based Cognitive Behavioral Intervention for Adults Receiving Long-term Opioids for Chronic Pain. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Road to excellence in pain management: research, outcomes and direction (ROAD). [2019]

4. United States pubmed.ncbi.nlm.nih.gov

"The Pain Doesn't Have to Control You." A Qualitative Evaluation of Three Pain Clinics Teaching Nonopioid Pain Management Strategies. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Correlates of Use and Perceived Effectiveness of Non-pharmacologic Strategies for Chronic Pain Among Patients Prescribed Long-term Opioid Therapy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Lessons learned from examination of Canadian medico-legal cases related to interventional therapies for chronic pain management. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

The Oslo University Hospital Pain Registry: development of a digital chronic pain registry and baseline data from 1,712 patients. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Strategies to manage auxiliary pain medications in chronic pain trials: a topical review. [2022]

11. Spain pubmed.ncbi.nlm.nih.gov

[Efectividad de una intervención multimodal para la mejora de la atención al dolor crónico.] [2023]

12. England pubmed.ncbi.nlm.nih.gov

Reframing chronic pain as a disease, not a symptom: rationale and implications for pain management. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for chronic pain: Evidence and applications. [2022]

14. France pubmed.ncbi.nlm.nih.gov

[Management of chronic pain in the future]. [2015]