Selecting Effective Combinations of Treatment for Low Back Pain

NACompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

November 15, 2018

Primary Completion Date

June 30, 2020

Study Completion Date

August 30, 2020

Conditions
Low Back Pain
Interventions
PROCEDURE

Lumbar medial branch nerve radiofrequency ablation (LRFA)

Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.

PROCEDURE

Simulated LRFA with targeted steroid injections

Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.

BEHAVIORAL

AcTIVE-CBT

AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.

BEHAVIORAL

TBSCE

TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.

Trial Locations (1)

98108

VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT03520387 - Selecting Effective Combinations of Treatment for Low Back Pain | Biotech Hunter | Biotech Hunter