Hand osteoarthritis
Conditions
Interventions
Trade Name: Cymbalta
Product Name: Duloxetine, Cymbalta
Pharmaceutical Form: Capsule
INN or Proposed INN: Duloxetine hydrochloride
CAS N
Sponsors
St George's University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants fulfilling: 1.the American College of Rheumatology (ACR) criteria for the diagnosis of hand osteoarthritis, 2.right or left -handed 3.male or female 4.aged 40-75 5.On usual care for hand osteoarthritis including paracetamol and/or NSAIDs Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. other rheumatological diagnosis e.g. rheumatoid arthritis 2. current or planned pregnancy 3. contraindications to duloxetine or pregabalin such as MAOI, SSRI, antidepressants, oral contraceptives, St John’s wort 4. history of depression 5. concomitant use of opioids including tramadol and pethidine 6. recent surgery i.e 2.5 X ULN within 6 weeks of last clinical assessment 12. ischaemic heart disease 13. diabetes mellitus 14. regular use of alcohol or alcohol abuse(maximum limits are 28 units/week for men and 21 units/ week for women) 15. lactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The proposed study is based on the hypothesis that pain in hand osteoarthritis is due to local changes in the joint and the switching on of pain pathways in the brain that mediate chronic pain. The overall aim of this study is to determine whether drugs which influence central brain pain processing pathways can improve pain management in hand osteoarthritis. The primary objective of this study is to determine the effects of centrally acting drugs duloxetine and pregabalin versus placebo on pain perception in hand osteoarthritis using clinical pain scores.;Secondary Objective: The secondary research question in this study is to determine whether the drugs to be used in this study will change the perception of pain using local algometer testing of pain thresholds in the hand, wrists and sternum.;Timepoint(s) of evaluation of this end point: The baseline VAS will be measured and then values post-treatment collected in each participant at weeks 4 and 13.;Primary end point(s): The primary outcome measure will be change in visual analogue score (VAS) for pain and the study is powered to detect statistically significant differences in change between groups. The VAS is a well-known method of rating pain on a continuous scale. Participants will be asked to score their VAS pain rating on a 0-100mm scale on a weekly basis which will be recorded in their diary card and CRF from week 1 to 13 weeks. Upon completion of the study, the change in VAS from baseline to 13 weeks will be used as the primary clinical endpoint for each participant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical data analysis will include mean change in AUSCAN, neuropathic pain scores and pain threshold values using algometer readings from baseline to 13 weeks in the 3 groups across 30 joints per hand, both elbows and sternum.;Timepoint(s) of evaluation of this end point: Pain thresholds will be measured at baseline and then values post-treatment collected in each participant at week 13. | — |
Countries
United Kingdom
Contacts
Public ContactSt George's Joint Research Office
St George's University of London
Outcome results
None listed