Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04441034 · ClinicalTrials.gov registry record · Phase 4
Stanford Pragmatic Effectiveness Comparison
A Phase 4 study of Chronic Pain, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 450
- Enrollment target
- 1
- Study location
NCT04441034: Recruiting Phase 4 study of Chronic Pain, sponsored by Stanford University.
NCT04441034 is a Phase 4 study of Chronic Pain that is actively recruiting participants, run by Stanford University. The registered enrollment target is 450 participants, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04441034, a Phase 4 study of Chronic Pain, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 450 participants
- Enrollment target
- 1
- Study location
Study 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 gen
Primary Outcome
Change in pain intensity on numerical rating scale (0-10; worse is higher) of pain at 6 months
Conditions Studied
Interventions
- DRUG Anti-convulsant medications
- DRUG Anti-depressant medications
Study Locations (1)
California
- Stanford Pain Management Center - Redwood City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2022-04-12 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 4 |
What NCT04441034 shows while recruiting
NCT04441034 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which Anti-convulsant medications is the first listed.
NCT04441034 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04441034 about?
NCT04441034 is a clinical study titled "Stanford Pragmatic Effectiveness Comparison". 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 ou...
What is the current status of trial NCT04441034?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 450 participants. The study started on 2022-04-12. Estimated completion is 2026-04-30.
What conditions does trial NCT04441034 study?
This clinical trial studies the following conditions: Chronic Pain.
What interventions are being tested in trial NCT04441034?
The interventions under investigation include: Anti-convulsant medications (DRUG), Anti-depressant medications (DRUG).
Who is sponsoring clinical trial NCT04441034?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04441034 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04441034's enrollment target sits among peer trials
450 26th of 301 higher than 274 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow
RECRUITING · Phase 4
-
Better Options for Chronic Cancer Pain
RECRUITING · Phase 4
-
Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
RECRUITING · Phase 4
-
Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
ACTIVE NOT RECRUITING · Phase 4
-
Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression
ACTIVE NOT RECRUITING · Phase 4
-
PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00515060 · 450 participants
Psychophysical Studies of Cancer Therapy Pain
- NCT01257269 · 450 participants
Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome)
- NCT03047161 · 450 participants
Electrophysiology of Fetal Arrhythmia
- NCT03269630 · 450 participants
New Orleans Pulmonary Hypertension Biobank
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI