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Completed

NCT Number: NCT02612233

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

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.

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Key information

Conditions

Hand Osteoarthritis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotung Centre for Musculoskeletal Diseases

London, SW17 ORE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pregabalin or Duloxetine or Placebo

Drug

This is a randomized, double blind placebo controlled trial with a head-to-head comparison of duloxetine vs pregabalin vs placebo over-encapsulated to prevent unblinding of treatment arm

Other names: DUPRO Capsules

Primary outcomes

  1. Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)

    Time frame: 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.

Secondary outcomes

  1. Brain magnetic resonance imaging (MRI)

    Time frame: Baseline and 12 weeks after treatment

    Changes between baseline MRI and post-treatment after 12 weeks of intervention will be measured using functional neuroimaging to assess pain center activation before and after intervention.

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • Rosetrees Trust

Registry information

Acronym: DUPRO

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 23, 2015
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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