N/A N=120 Randomized Double-blind Treatment

Study of Opioid Use After Lumbar and Cervical Spine Surgery

Low Back Pain · Opiate Addiction · Neck Pain

Bottom Line

View on ClinicalTrials.gov: NCT02674711 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Number of Opioid Medication Prescriptions — 5.0; 5.1 prescriptions count

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Educational Video (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brooke Army Medical Center
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Opioid Medication Prescriptions	5.0; 5.1	—
SECONDARY Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI)	41.7; 37.8	—
SECONDARY Numeric Pain Rating Scale (NPRS)	5.7; 5.1	—

Summary

The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records.

Eligibility Criteria

Inclusion Criteria

Currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or neurosurgeon specifically for a lumbar surgery.
Surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
Between the age of 18 - 65 years
Read and speak English well enough to understand the education, provide informed consent and follow study instructions

Exclusion Criteria

a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02674711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.