Stanford Pragmatic Effectiveness Comparison

NCT04441034 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB-57237
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is a major healthcare problem with an annual cost of above $600 billion. The quality of data available for treatments of chronic pain is not optimal. Generalizability of explanatory randomized controlled trial data is problematic as these trials exclude up to 90% of patients: leaving out real-world patients with serious medical and psychological comorbidities. Pragmatic trials embedded in patient care compare effectiveness of currently used treatments in real-world application leading to findings that generalize to broader range of patients. The changes in clinical practice and workflow necessary to integrate this type of research within patient care present pragmatic challenges. In this research, the overall objective is to overcome these challenges using an open-source learning health care system - CHOIR. CHOIR is currently used to track patients' clinical trajectory and treatment response across multiple academic sites resulting in over 25 publications characterizing chronic pain. Through the pilot studies, the investigators have already developed a point-of-care randomization for CHOIR that facilitates integration of research and patient care by allowing the physicians to randomize patients during clinic visits. The investigators have already demonstrated feasibility of the randomization and data collection platform in two ongoing pilot pragmatic clinical trials. The investigators are proposing to better integrate pragmatic research within clinical practice through conducting a randomized comparative effectiveness trial in 450 patients with chronic pain comparing effectiveness of anti-convulsants and anti-depressants (two most commonly used classes of medications for treatment of chronic pain). The investigators will also perform a qualitative interview with all physicians in our clinic to study the impact of integrating pragmatic research into clinical care. The investigators will use the data available in CHOIR as well as the real-world data generated from this clinical trial to build, validate and test a model to predict what clinical characteristics can predict response to either of these classes of medications. The proposed study is the first step to use flexible point-of-care randomization to compare effectiveness of different treatments in different subgroups of patients whenever equipoise exists. The prediction model will guide decision making process of clinicians choosing between these medications based on clinical characteristics of individual patients.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Change in pain intensity on numerical rating scale (0-10; worse is higher) of pain at 6 months

  6 months

Secondary Outcomes (6)

• Change in Pain Interference

  6 months

• Change in Depression

  6 months

• Change in Anxiety

  6 months

• Change in Sleep Disturbance

  6 months

• Change in Pain Catastrophizing

  6 months

Study Arms (2)

Anti-convulsant medication

EXPERIMENTAL

The participants will be randomized to receiving an anti-convulsant medication. Then using a patient centered approach, the participant and their treating pain provider will choose one medication within the class. Participants will continue the medications for at least 6 months provided that they can tolerate the side effects, consider the treatment effective, and are willing to continue the treatment. We are studying two classes of medications and specific names of medications do not apply.

Drug: Anti-convulsant medications

Anti-depressant medication

EXPERIMENTAL

The participants will be randomized to receiving an anti-depressant medication. Then using a patient centered approach, the participant and their treating pain provider will choose one medication within the class. Participants will continue the medications for at least 6 months provided that they can tolerate the side effects, consider the treatment effective, and are willing to continue the treatment. We are studying two classes of medications and specific names of medications do not apply.

Drug: Anti-depressant medications

Interventions

Anti-convulsant medications DRUG

Anti-convulsants are very commonly used to treat patients with chronic pain.

Anti-convulsant medication

Anti-depressant medications DRUG

Anti-depressants are very commonly used to treat patients with chronic pain.

Anti-depressant medication

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years old or above
• Persistent pain for more than 3 months
• Candidate for treatment by anti-convulsants or anti-depressants based on treating pain provider
• Equipoise between anti-convulsants and anti-depressants according to the treating pain provider

You may not qualify if:

• Patient refusal

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Pain Management Center

Redwood City, California, 94063, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vafi Salmasi, MD

CONTACT

6507250246; vsalmasi@stanford.edu

Corinne E Jung, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-arm parallel randomized clinical trial

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 22, 2020
• Study Start: April 12, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)