None listed
Conditions
Brief summary
Pregabalin and gabapentin are two medications commonly used to treat neuropathic pain. While both are moderately effective, there is significant variation between individuals, with patients often responding to one medication but not the other. N-of-1 trials are clinical trials that study a single patient, facilitating personalized data collection and reporting. We hypothesize that N-of-1 trials are a feasible method of comparing between pregabalin and gabapentin for individual patients with neuropathic pain.
Interventions
Participants will undergo a 12-week trial comprising three 4-week treatment cycles. Each cycle will consist of a 2-week gabapentin block and a 2-week pregabalin block in an individually randomised order. During each block, participants will take their respective medication orally three times daily, with doses derived from the participant's existing neuropathic pain treatment dose. Throughout the trial, participants will complete a daily patient diary, reporting on relevant neuropathic pain sympt
Participants will undergo a 12-week trial comprising three 4-week treatment cycles. Each cycle will consist of a 2-week gabapentin block and a 2-week pregabalin block in an individually randomised order. During each block, participants will take their respective medication orally three times daily, with doses derived from the participant's existing neuropathic pain treatment dose. Throughout the trial, participants will complete a daily patient diary, reporting on relevant neuropathic pain symptoms such as daily pain, sleep interference, and functional limitation. At the end of each block, participants will return their unused medications and finished patient diaries. After the 12-week trial, participants will complete a review appointment with their treating physician, in which the results of the trial will be presented to facilitate an informed and long-term treatment decision. Participants and physicians will additionally provide feedback on their experiences with the trial, as well as suggestions for further improvement.
Sponsors
Department of Rehabilitation Medicine Port Kembla Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Existing patient at Port Kembla Hospital 2. Age 18 years or greater 3. Existing diagnosis of chronic and stable neuropathic pain. 4. Currently prescribed gabapentin for neuropathic pain. 5. Willingness to maintain pain medications and treatments throughout the trial. 6. Capable English speaker 7. Able to be reliably contacted by telephone.
Exclusion criteria
1. Currently breastfeeding or pregnant 2. Gabapentin or pregabalin allergy or intolerance 3. Active or past history of seizures 4. Creatinine clearance under 30 mL/min. 5. Likelihood of surgery during the trial 6. Inability to attend review visits
Outcome results
None listed