Clinical trial NCT02612233: Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin
Official title: Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Osteoarthritis
Keywords: Pain
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: Rosetrees Trust
First posted: 2015-11-23
Enrollment: 81
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)
timeFrame: 12 weeks
Secondary outcomes:
measure: Brain magnetic resonance imaging (MRI)
timeFrame: Baseline and 12 weeks after treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hotung Centre for Musculoskeletal Diseases
Study officials:
affiliation: St George's, University of London
name: Nidhi Sofat, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: