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

JRCT ID: jRCT1041210147

Registered date:17/02/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic low back pain
• Date of first enrollment: 17/02/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

This will be a single-centre, randomised, open-label, parallel-group study with the following two arms
(1) Duloxetine group (Group A)
(2) Inflamed skin extracts from rabbits inoculated with vaccinia virus (Group B)

Duloxetine (test drug) will be compared with vaccinia virus-inoculated rabbit inflammatory skin extract (control drug) for the treatment of patients with chronic low back pain of NRS3 or higher who have a CSI of 30 or higher for at least 3 months at the outpatient clinic of the Department of Orthopaedic Surgery, Hamamatsu University School of Medicine. Patients will be randomised to minimise bias in patient background and the efficacy of the test drug will be assessed by a parallel group comparison of the two groups, with the change in the primary endpoint being the change in NRS at 12 weeks.

Outcome(s)

• Primary Outcome: Amount of change in NRS for low back pain from study enrolment (baseline) to week 12

Secondary Outcome

Change in low back pain NRS from study enrollment to weeks 4 and 8
Change in EQ-5D from study enrollment to weeks 4, 8 and 12
Change in CSI from study enrollment to weeks 4, 8 and 12

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 89age old
• Gender: Both

Include 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.

Exclude 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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Related Information

• Primary Sponsor: Kurosu Kenta