Randomised controlled study of the efficacy of duloxetine in patients with chronic low back pain suspected of central sensitisatio

Not Applicable

• Conditions: Chronic low back pain; low back pain, central sensitization, CSI

• Registration Number: JPRN-jRCT1041210147
• Lead Sponsor: Kurosu Kenta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients who meet all of the following criteria will be eligible
1) Patients with low back pain and a CSI of 30 or higher at the time of study enrollment
(2) Patients whose onset of low back pain can be determined to be more than 3 months ago.
3) Patients who have not changed the dose of anti-inflammatory or analgesic medication for at least 4 weeks prior to enrollment in the study
4) Patients who have not used preparations containing duloxetine and vaccinia virus-inoculated rabbit inflammatory skin extracts for more than 4 weeks prior to study enrollment
5) Patients with an NRS of 3 or higher at the time of consent and study enrollment
(6) Patients aged 20 years or older at the time of consent.
(7) Patients who can understand the procedures of the study, can answer questions appropriately, and can give their written consent to participate in the study.

Exclusion Criteria

(1) Patients who have changed the dosage of concomitantly restricted drugs within 4 weeks prior to study enrollment
(2) Patients with severe pain at the time of study enrollment that is considered difficult to assess.
(3) Patients with cancer, infection, bone fracture, or rheumatoid arthritis at the time of study enrollment
(4) Patients with a history of hypersensitivity to any component of the drug used.
5) Patients with serious hepatic, renal or cardiac complications that make it difficult to participate in the study
6) Patients with angle-closure glaucoma
7) Patients on MAO inhibitors or within 2 weeks of discontinuation of MAO inhibitors
8) Pregnant women or patients who may be pregnant or lactating
9) Patients with active psychiatric problems at the time of study enrollment
(10) Patients who are judged unsuitable for participation in the study by the principal investigator or sub-investigator.

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Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of change in NRS for low back pain from study enrolment (baseline) to week 12

Secondary Outcome Measures

Name	Time	Method
Change in low back pain NRS from study enrollment to weeks 4 and 8<br>Change in EQ-5D from study enrollment to weeks 4, 8 and 12<br>Change in CSI from study enrollment to weeks 4, 8 and 12