The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain

UMIN ID: UMIN000039713

Registered date:06/03/2020

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-specific chronic low back pain
• Date of first enrollment: 2017/02/02
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): A comobination of supervised physical exercise and duloxetine administration. exercise: Patients were required to attend the program(tunk muscle stretching and strengthening) at outpatients rehabilitation center once a week or once in 2 weeks and advised to continue exercise at home for 15 weeks. Duloxetine: Oral administration started frrom 20 mg before sleeping for 1 week and increased to 40 mg after 1 week and then maxium dose of 60 mg over 15 weeks with flexible dose method.

Outcome(s)

• Primary Outcome: Roland-Morris Disability Questionnaire (RDQ) Timepoints: baseline and 15 weeks after intervention
• Secondary Outcome: Numerical rationg scale (NRS), Pain catastrophizing scale (PCS), Hospital anxiety and depression scale (HADS) Timepoints: baseline and 15 weeks after intervention

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: Malalignment of the lumbar spine, spondylolysis, spondylolisthesis, disc herniation, infection, spinal compression fracture, and tumor. Furthermore,exclusion criteria included a history of previous lumbar spine surgery; severe cardiovascular, hepatic, or renal disorders; pregnancy; gait disturbance requiring crutches or a walker; any type of treatment for LBP within 1 month before the first visit; and psychogenic disorders.

Related Information

• Primary Sponsor: Zenshukai Hospital
• Source(s) of Monetary Support: No funding