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临床试验/NCT02612233
NCT02612233已完成4 期

Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin

St George's, University of London1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
81
试验地点
1
主要终点
Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)

研究概览

简要总结

Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis of the hands affects millions of people and is a major cause of hand disability and pain. Despite this, there are currently no treatments that delay or halt the development of osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is an important factor to consider in the treatment of this condition. Treatments for pain in osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as paracetamol. However, most people with osteoarthritis still have pain despite these treatments.

详细描述

Recent scientific studies have suggested that people with hand osteoarthritis not only feel pain in their hand joints, they also appear to have increased signals in their brain pain processing pathways. At St George's, University of London, the investigators have been conducting studies to find out which brain regions are activated in subjects with hand osteoarthritis. The investigators have found that certain brain regions (thalamus, insula, cingulate and somatosensory cortex) are activated during painful tasks in patients with hand osteoarthritis but not in healthy people. In this study the investigators will establish whether drugs that inhibit pain processing pathways in the brain can help. Patients who are still having pain despite their usual painkillers will be randomly divided into 3 groups: one group will receive a placebo, the other 2 groups will receive one of two different drugs, duloxetine or pregabalin. Participants will be assessed using questionnaires and a brain scan (functional MRI) before and after 13 weeks of taking the tablets. This study will help us to understand the ways in which people feel pain in osteoarthritis. If our trial proves successful,drugs that dampen central pain pathways could be used in combination with local pain-relieving drugs to improve treatment and reduce disability in patients with hand osteoarthritis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of hand osteoarthritis
  • Participants with hand osteoarthritis presenting to rheumatology outpatient clinics and primary care.
  • Participants will be right or left handed
  • Male or female
  • Age between 40 and 75
  • Participants will be on usual care for hand osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs

排除标准

  • Participants with other rheumatological diagnoses e.g. rheumatoid arthritis
  • Current or planned pregnancy
  • Contraindications to duloxetine or pregabalin
  • History of depression
  • Recent surgery
  • Previous use of duloxetine and/or pregabalin

研究组 & 干预措施

Pregabalin

Active Comparator

Pregabalin 150mg ON week 1 increased to Pregabalin 300mg ON weeks 2-11 then decrease to Pregabalin 150mg ON week 12 then STOP

干预措施: Pregabalin or Duloxetine or Placebo (Drug)

Duloxetine

Active Comparator

Duloxetine 30mg ON week 1 increase to Duloxetine 60mg weeks 2-11 then decrease to Duloxetine 30mg ON week 12 then STOP

干预措施: Pregabalin or Duloxetine or Placebo (Drug)

Placebo

Placebo Comparator

1 capsule ON week 1- increase to 2 capsules ON week 2-11 then decrease to 1 capsule ON week 12 then STOP.

干预措施: Pregabalin or Duloxetine or Placebo (Drug)

结局指标

主要结局

Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)

时间窗: 12 weeks

The AUSCAN measures pain and hand function. Differences between baseline AUSCAN and after treatment will be recorded for each participant to assess for improvement in AUSCAN pain and function score after the trial intervention.

次要结局

  • Brain magnetic resonance imaging (MRI)(Baseline and 12 weeks after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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