Individualized Cognitive Functional Therapy Compared with Conservative Treatment for Patients with Chronic Neck Pain-Study Protocol for a Single Blind Pragmatic Randomized Controlled Trial.

ABSTRACT

Chronic neck pain (CNP) is one of the most common musculoskeletal conditions, is considered the second leading cause of pain, and is among the leading causes of disability. Cognitive Functional Therapy (CFT) is a novel behavioral therapy for individualizing the management of spinal pain targeting the multidimensional aspect of musculoskeletal pain. This study outlines the protocol for an assessor-blind randomized controlled trial (RCT) designed to compare an individualized Cognitive Functional Therapy (CFT) intervention with usual care in terms of pain and disability. Aiming for a pragmatic intervention, the CFT group will receive 16 sessions based on patient's condition characteristics, and clinical presentation and progression. The control group will receive 16 sessions of standardized usual care (electrotherapy, massage, posture exercise, and educations). Both groups will have the same intervention duration. Patients will be randomly allocated into groups and will be assessed at baseline, at the 8th session, at the 16th session, and 3 months after randomization. Primary outcomes will be pain, disability, cervical range of motion, and neck muscle isometric strength. To our knowledge, this study will be the first RCT to compare the clinical effectiveness of CFT compared to UC for adults with CNP. The study results will provide information about the use of CFT in clinical practice.