← Back to Search

Non-Pharmacological Pain Management Strategies for Chronic Pain (wHOPE Trial)

N/A

Waitlist Available

Research Sponsored by San Francisco Veterans Affairs Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

wHOPE Trial Summary

This trial is testing whether a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management, can reduce pain symptoms and improve overall functioning and quality of life in Veterans.

Who is the study for?

This trial is for veterans with chronic pain that's present almost every day for at least 6 months. They must be under VA primary care and have a PEG score of 5 or more, indicating significant pain. Those with active suicidality, severe psychiatric conditions, cognitive impairment, non-English speakers, or plans to move within a year are excluded.Check my eligibility

What is being tested?

The study compares three approaches in managing chronic pain: Whole Health Team (WHT) intervention, Primary Care Group Education (PC-GE), and usual care. It aims to see if WHT improves pain management better than PC-GE and regular care by reducing medication use and enhancing life quality over 12 months.See study design

What are the potential side effects?

Since the interventions focus on non-pharmacological strategies like self-management education rather than medications, typical drug side effects aren't expected. However, participants may experience varying levels of discomfort or stress from engaging in new activities.

wHOPE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improved pain interference

Secondary outcome measures

Decreased use of higher-risk pain medications, including opioids or high-risk combinations of pain medications (i.e., co-prescription of opioids and benzodiazepines)

Engagement in a greater number of non-pharmacological pain management activities

Functioning and quality of life

+2 more

wHOPE Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Primary Care Group Education (PC-GE) Intervention ArmActive Control1 Intervention

Primary Care Group Education (PC-GE) iss the comparator arm, which is an abbreviated form of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) adapted for group use in primary care.

Group II: Whole Health Team (WHT) Intervention ArmActive Control1 Intervention

The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care.

Group III: Usual Primary Care (UPC) ArmPlacebo Group1 Intervention

In VA, patient-aligned care teams (PACTs) or primary care is step 1 of VA's Stepped Care Model in the treatment of chronic pain. PCPs are expected to possess the requisite skill set for management of common chronic pain-causing conditions, which includes biopsychosocial assessment, multi-modal treatment, and coordination of specialty pain care after shared-decision making that incorporates patient preferences and values. Participants randomized to this arm will continue to have their PCP and PACT serve in this role.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

San Francisco Veterans Affairs Medical CenterLead Sponsor

48 Previous Clinical Trials

210,018 Total Patients Enrolled

1 Trials studying Chronic Pain

100 Patients Enrolled for Chronic Pain

Media Library

Primary Care Group Education (PC-GE) Intervention Arm Clinical Trial Eligibility Overview. Trial Name: NCT04330365 — N/A

Chronic Pain Research Study Groups: Primary Care Group Education (PC-GE) Intervention Arm, Whole Health Team (WHT) Intervention Arm, Usual Primary Care (UPC) Arm

Chronic Pain Clinical Trial 2023: Primary Care Group Education (PC-GE) Intervention Arm Highlights & Side Effects. Trial Name: NCT04330365 — N/A

Primary Care Group Education (PC-GE) Intervention Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04330365 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have taken part in this experiment?

"In order to successfully conduct this trial, 745 patients meeting the prerequisites need to take part. Potential participants can register at various sites including VA St. Louis Health Care System in Saint Louis, Missouri and VAPHCS in Portland, Oregon."

Answered by AI

Are there still openings for prospective participants in this clinical trial?

"Affirmative. The information accessible on clinicaltrials.gov indicates that this medical research, which was initially listed on September 15th 2020 is actively seeking out participants. 745 individuals from 3 different locations are required for the trial's success."

Answered by AI