RECRUITING

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

Conditions

Chronic Pain Back Pain Neck Pain Opioid Misuse

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Three-arm randomized controlled trial, of Motivational Interviewing and guided Opioid Tapering support (MI-Opioid Taper) and tizanidine vs. MI-Opioid Taper and placebo vs. enhanced usual care to promote postoperative opioid cessation and pain cessation and reduce the incidence of postoperative opioid misuse among patients undergoing spine surgery.

Official Title

Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Spine Surgery

Quick Facts

Study Start:2024-12-05

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06027099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Adults aged 18-64 scheduled for elective spine surgery for lumbar or cervical degenerative disease (e.g. lumbar or cervical disc herniation, lumbar or cervical spinal stenosis, lumbar or cervical degenerative spondylolisthesis, lumbar or cervical disc degeneration, or degenerative cervical myelopathy including cervical spondylotic myelopathy). * Preoperative long-term opioid use (Defined as ≥ 90-day duration of use in the 4 months preceding surgery either via self-report or state PDMP. * Participants must report at least one of the following on preoperative assessments: * Elevated opioid use 14 days after surgery compared to baseline daily OME Defined as average daily OME assessed over 3 days 1 week before surgery compared to average daily OME reported on postoperative days 12 to 14 to account for as-needed dosing and day-to-day variations in opioid use. * English-speaking * Ability and willingness to complete online assessments	* Infection, tumor, or fracture at the operative site * Allergy or intolerance to tizanidine * Current use of tizanidine * Renal impairment * Hepatic impairment including cirrhosis or elevated enzymes * Concurrent use of other α2-adrenergic agonists, skeletal muscle relaxants * Concurrent use of: fluvoxamine, ciprofloxacin,zileuton, fluoroquinolones, antiarrhythmics (amiodarone, mexiletine, propafenone, verapamil), cimetidine, famotidine, oral contraceptive pills, acyclovir, ticlopidine, and fexinidazole * Pre-existing hypotension, sedation, dizziness, severe respiratory insufficiency. * Opioid Use Disorder * Suicidality as assessed by the Patient Health Questionnaire-9 (PHQ-9) Question 9 score ≥ 1 * Pregnancy, breastfeeding, or planning to conceive * Cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome * Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status) * Participating in another clinical trial with an active treatment arm

Inclusion Criteria

Exclusion Criteria

* Adults aged 18-64 scheduled for elective spine surgery for lumbar or cervical degenerative disease (e.g. lumbar or cervical disc herniation, lumbar or cervical spinal stenosis, lumbar or cervical degenerative spondylolisthesis, lumbar or cervical disc degeneration, or degenerative cervical myelopathy including cervical spondylotic myelopathy).
* Preoperative long-term opioid use (Defined as ≥ 90-day duration of use in the 4 months preceding surgery either via self-report or state PDMP.
* Participants must report at least one of the following on preoperative assessments:
* Elevated opioid use 14 days after surgery compared to baseline daily OME Defined as average daily OME assessed over 3 days 1 week before surgery compared to average daily OME reported on postoperative days 12 to 14 to account for as-needed dosing and day-to-day variations in opioid use.
* English-speaking
* Ability and willingness to complete online assessments

* Infection, tumor, or fracture at the operative site
* Allergy or intolerance to tizanidine
* Current use of tizanidine
* Renal impairment
* Hepatic impairment including cirrhosis or elevated enzymes
* Concurrent use of other α2-adrenergic agonists, skeletal muscle relaxants
* Concurrent use of: fluvoxamine, ciprofloxacin,zileuton, fluoroquinolones, antiarrhythmics (amiodarone, mexiletine, propafenone, verapamil), cimetidine, famotidine, oral contraceptive pills, acyclovir, ticlopidine, and fexinidazole
* Pre-existing hypotension, sedation, dizziness, severe respiratory insufficiency.
* Opioid Use Disorder
* Suicidality as assessed by the Patient Health Questionnaire-9 (PHQ-9) Question 9 score ≥ 1
* Pregnancy, breastfeeding, or planning to conceive
* Cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome
* Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
* Participating in another clinical trial with an active treatment arm

Contacts and Locations

Study Locations (Sites)

Stanford University Hospital

Stanford, California, 94304

United States

Collaborators and Investigators

Sponsor: Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-05

Study Completion Date2028-07

Study Record Updates

Study Start Date2024-12-05

Study Completion Date2028-07

Terms related to this study

Additional Relevant MeSH Terms

Chronic Pain
Back Pain
Neck Pain
Opioid Misuse