True Functional Restoration and Analgesia in Non-Radicular Low Back Pain

PHASE4UnknownINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 3, 2022

Primary Completion Date

July 31, 2023

Study Completion Date

July 31, 2023

Conditions
Back Pain Lower Back ChronicChronic Pain
Interventions
DRUG

Buprenorphine Buccal Film [Belbuca]

buprenorphine buccal film is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

OTHER

Urine Drug Screening

Urine drug screening to include controlled prescription medication as well as illicit substances to monitor compliance

DEVICE

actigraph

Subjects will wear this device to monitor sleep and activity

BEHAVIORAL

PROMIS 29

questionnaire will be administered once a week via e-dairy to monitor mood and sleep

OTHER

sit to stand test

Subjects will complete this daily with specific instructions through the e-diary

OTHER

numerical rating scale pain score

subjects will be asked a pain score in the morning, prior to, and after sit-to-stand testing, and at night

BEHAVIORAL

patient global impression of function

subjects will be asked three questions once a day to assess their personal impression of functional status

BEHAVIORAL

PROMIS - sleep

Subjects will answer 5 questions about sleep every morning via e-diary

Trial Locations (1)

27103

RECRUITING

Carolinas Pain Institute, Winston-Salem

Sponsors
All Listed Sponsors
collaborator

BioDelivery Sciences International

INDUSTRY

lead

Carolinas Pain Institute

OTHER