Trial | NCT02612233  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    81
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.
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.
Study Started
Sep 30
2013
Primary Completion
May 31
2016
Study Completion
Jul 31
2016
Last Update
Jul 20
2016
Estimate

Drug Pregabalin or Duloxetine or Placebo

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

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

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.

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

Criteria 

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
No Results Posted