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

Hand Osteoarthritis Clinical Trial

— DUPRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612233
• Other study ID #: 11.0126
• Secondary ID: 2011-003803-39
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2015
• Last updated: July 19, 2016
• Start date: September 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Hotung Centre for Musculoskeletal Diseases	London

Sponsors (2)

Lead Sponsor	Collaborator
St George's, University of London	Rosetrees Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)	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.	12 weeks	No
Secondary	Brain magnetic resonance imaging (MRI)	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.	Baseline and 12 weeks after treatment	No

External Links

•   UK CRN website