# Duloxetine and cognitive behavioral therapy with phone-based support for the treatment of chronic musculoskeletal pain: study protocol of the PRECICE randomized control trial

## TL;DR

This study tests if combining a drug with web-based therapy and phone support helps more than the drug alone for chronic pain.

## Contribution

The study introduces a novel combination of duloxetine, web-based CBT, and phone-based motivational interviewing for chronic musculoskeletal pain.

## Key findings

- Combination treatment with duloxetine and CBT may improve pain outcomes compared to duloxetine alone.
- Phone-based motivational interviewing could enhance adherence to CBT coping skills.
- Blinded outcome assessments will ensure unbiased evaluation of treatment effects.

## Abstract

Chronic musculoskeletal pain (CMP) is the most common, disabling, and costly of all pain conditions. While evidence exists for the efficacy of both duloxetine and web-based cognitive behavioral therapy (CBT) as monotherapy, there is a clear need to consider study of treatment components that may complement each other. In addition, given the reported association between patient’s adherence and treatment outcomes, strategies are needed to enhance participant’s motivation to adopt and maintain continued use of newly learned pain coping skills from CBT.

Two hundred eighty participants will be recruited from the primary care clinics of a large academic health care system in North Carolina. Participants with CMP will be randomized to one of three treatment arms: (1) combination treatment (duloxetine + web-based self-guided CBT) with phone-based motivational interviewing (MI), (2) combination treatment without phone-based MI, and (3) duloxetine monotherapy. Participants will be in the study for 24 weeks and will be assessed at baseline, week 13, and week 25. The primary outcome is the Brief Pain Inventory (BPI)-Global Pain Severity score, which combines BPI pain severity and BPI pain interference. Secondary measures include between-group comparisons in mean BPI pain severity and BPI pain interference scores. Data collection and outcome assessment will be blinded to treatment group assignment.

This randomized controlled trial (RCT) will determine if combination treatment with duloxetine and web-based CBT is superior to duloxetine monotherapy for the management of CMP. Furthermore, this RCT will determine the effectiveness of phone-based motivational interviewing in promoting the continued practice of pain coping skills, thereby enhancing treatment outcomes.

NCT04395001 ClinicalTrials.gov. Registered on May 15, 2020.

The online version contains supplementary material available at 10.1186/s13063-024-08158-x.