Journal Article

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

Miles, Christopher, Ang, Dennis C., Chen, Haiying, Davuluri, Swetha, Rini, Christine, Kaplan, Sebastian, Keefe, Francis

2024

Overview

Background 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. Methods 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. Discussion 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. Trial registration NCT04395001 ClinicalTrials.gov. Registered on May 15, 2020.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adaptation, Psychological / Adult / Analgesics - therapeutic use / Analysis / Antidepressants / Arthritis / Back pain / Behavior modification / Behavioral health care / Biomedicine / Care and treatment / Chronic musculoskeletal pain / Chronic pain / Chronic Pain - drug therapy / Chronic Pain - psychology / Chronic Pain - therapy / Clinical trials / Cognitive behavioral therapy / Cognitive Behavioral Therapy - methods / Cognitive therapy / Combined Modality Therapy / Duloxetine / Duloxetine Hydrochloride - therapeutic use / Fibromyalgia / Health Sciences / Humans / Informed consent / Internet-Based Intervention / Intervention / Medicine / Medicine & Public Health / Motivational Interviewing / Musculoskeletal Pain - diagnosis / Musculoskeletal Pain - drug therapy / Musculoskeletal Pain - psychology / Musculoskeletal Pain - therapy / Narcotics / Osteoarthritis / Pain / Pain management / Pain Management - methods / Pain Measurement / Primary care / Randomized controlled trial / Randomized Controlled Trials as Topic / Statistics for Life Sciences / Study Protocol / Telephone / Time Factors / Treatment Outcome