Chronic musculoskeletal pain (CMP) is the most common, disabling, and costly of all pain problems. While evidence exists for the efficacy (albeit modest benefits) of both duloxetine and web-based cognitive behavioral therapy (CBT) as monotherapy, it is time 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 maintain continued use of newly learned pain coping skills from CBT. Using motivational interviewing (MI), a phone based adherence-focused guidance by a nurse clinician could make web-based CBT more effective. The objective of the UH3 application is to determine if combination therapy (duloxetine + web-based CBT) is more effective than duloxetine monotherapy for treating patients with CMP. Given the interactions of biological, behavioral and psychological mechanisms in the pathogenesis of chronic pain, our central hypothesis is that combination therapy will be more effective than duloxetine monotherapy. The objective of this UG3/UH3 application is to conduct a 24-week randomized clinical trial of primary care patients with CMP. In the UH3 trial, 450 participants will be randomized to one of three treatments: (1) combination treatment [duloxetine + web-based CBT] with nurse support, (2) combination treatment without nurse support, and (3) duloxetine monotherapy. This project could optimize pain-related treatment outcomes by combining duloxetine and web-based CBT at the primary care level where most pain patients are managed. Importantly, the use of nurse clinician providing adherence-focused guidance to maintain long term use or practice of pain coping skills (web-based CBT) increases the likelihood that our proposed intervention is scalable.

Public Health Relevance

Chronic musculoskeletal pain (CMP) is the most common, disabling, and costly of all pain problems. The World Health Organization reports that patients with moderate to severe pain are often undertreated, and views the provision of adequate pain relief as a significant challenge. Identifying the most effective treatment approaches for chronic pain should be a national priority. Given the interactions of biological, behavioral and psychological mechanisms in the pathogenesis of chronic pain, combination therapy (i.e., duloxetine and web- based cognitive behavioral therapy), is imperative in maximizing pain relief and improving physical function. The proposed use of clinic nurse will improve continued use of newly learned pain coping skills; and thereby, enhancing the effectiveness of web-based CBT.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Project #
1UG3NR019196-01
Application #
9870024
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Tully, Lois
Project Start
2020-09-01
Project End
2024-08-31
Budget Start
2020-09-01
Budget End
2024-08-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157