The Cognitive Impact of Gabapentinoids in Patients with Fibromyalgia
Research type
Research Study
Full title
The Cognitive Impact of Gabapentinoids in Patients with Fibromyalgia - A Pilot Study.
IRAS ID
169690
Contact name
Bernhard Frank
Contact email
Sponsor organisation
The Walton Centre NHS Foundation Trust
Eudract number
2015-000055-25
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
In clinical practice patients diagnosed with fibromyalgia are often treated with gabapentinoids (gabapentin or pregabalin) and present with symptoms indicating problems with memory and concentration. These symptoms might be part of the fibromyalgia conditon or drug induced. Patients affected by these symptoms are thought not to gain the full benefit from the physical and psychological treatment offered by a pain management programme. The scientific evidence for gabapentinoids to improve pain and function in patients with fibromyalgia is limited. This study aims to detect differences in congitive function between patients with fibromyalgia taking gabapentinoids and patients with fibromyalgia not taking this type of drugs. To control for cognitive effects caused by fibromyalgia itself a control group of patients with neuropathic leg and low back pain as well as a group of healthy controls have been included. To reflect the patients seen in a pain clinic two groups are formed representing patients taking gabapentinoids and patients not taking gabapentinoids at the time of presentation and best after completion of pain management programme to reduce interference by psychological distress.
Patients on gabapentinoids will be randomised to wean themselves off these drugs and remain drug free for 4 weeks before re-testing to give time for clearing the body from the drug. Only patients with fibromyalgia not on gabapentinoids will be randomised to titrate into a therapeutic range of pregabalin of at least 300mg/day and remain stable on this dose for 4 weeks before re-testing. A battery of computerised cognitive tests will be performed at baseline and at the end of the study period. Pain intensity will be measured with a numerical rate scale. Primary outcome will be the difference in cognitive test performance between patient with fibromyalgia taking gabapentinoids and patients not taking gabapentinoids.REC name
North East - York Research Ethics Committee
REC reference
15/NE/0098
Date of REC Opinion
18 Mar 2015
REC opinion
Unfavourable Opinion