CARES-Spine (Comprehensive Analgesic, Recovery, and Education Support for Spine Surgery) Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

375

Participants

Timeline

Start Date

December 5, 2024

Primary Completion Date

January 31, 2028

Study Completion Date

July 31, 2028

Conditions
Chronic PainBack PainNeck PainOpioid Misuse
Interventions
DRUG

Tizanidine

Tizanidine 2mg three times a day for 5 weeks after surgery

BEHAVIORAL

MI-Opioid Taper

Motivational Interviewing (MI) and guided Opioid Tapering support adapting MI principles for enhancing motivation to change in pain treatment and tailoring key MI tools to postoperative opioid use delivered through weekly phone calls from weeks 2 to 7, and at week 11. The guided opioid tapering protocol will be a 25% total daily opioid dose reduction every 7 days with opioid discontinuation 7 days after reaching 1 opioid pill per day.

DRUG

Placebo

1 tablet three times a day for 5 weeks after surgery

BEHAVIORAL

Enhanced Usual Care

Participants will receive weekly phone calls from weeks 2 to 7, and at week 11. 1 topic per call will be reviewed in this sequence:1) standardized instructions on taking opioid medications after surgery, 2) safe opioid use, 3) avoiding medication errors, 4) local mental health resources and 988 Suicide \& Crisis lifeline, 5) disposal of unused medications, 6) prescription drug abuse, and 7) complementary health approaches for chronic pain. Education materials will be reviewed in a didactic style without a tailored discussion.

Trial Locations (1)

94304

RECRUITING

Stanford University Hospital, Stanford

All Listed Sponsors
lead

Stanford University

OTHER