None listed
Conditions
Brief summary
This study entails understanding the effects of palmitoylethanolamide on pain and brain activity. We hope to learn whether palmitoylethanolamide (a natural compound found in certain foods) reduces on-going pain in the face and how this is reflected in changes in brain anatomy and function. Participants will undergo initial screening which involves questionnaires and a 2 ml blood sample, then scanned using an MRI. Participants will then be assigned either the active drug or a placebo for a total of six weeks and asked to rate their pain daily for the entire period. After six weeks, participants will redo the questionnaires, provide another 2 ml of blood and be scanned using an MRI. We believe that after six weeks of treatment, patients will experience a decrease in pain intensity and MRI scans will show changes in anatomy and function that reflect the decreases in pain.
Interventions
Randomized control trial. A total of 60 subjects will be recruited for the study (60 subjects in total comprising 30 subjects in the active treatment and 30 subjects in the placebo group). Participants will be randomly (stratified by age and gender) assigned into either a treatment or placebo group. Treatment group will take 900mg of palmitoylethanolamide (3 x 300mg capsules) orally three times a day with food (morning, noon and night) - total of 2700 mg daily for a total of six weeks. There wil
Randomized control trial. A total of 60 subjects will be recruited for the study (60 subjects in total comprising 30 subjects in the active treatment and 30 subjects in the placebo group). Participants will be randomly (stratified by age and gender) assigned into either a treatment or placebo group. Treatment group will take 900mg of palmitoylethanolamide (3 x 300mg capsules) orally three times a day with food (morning, noon and night) - total of 2700 mg daily for a total of six weeks. There will be no modifications to the dosage and route of administration during the trial period. To measure patient compliance, at the 6 week follow-up scan, we will ask each subject to return their pill container. Full compliance will result in an empty bottle. At this point we will be able to ascertain whether there are any remaining pills to determine compliance. If there are any pills remaining we will ask the participant if there are reasons why the full complement of pills were not taken.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects with a diagnosis of orofacial / trigeminal neuropathic pain for longer than 3 months duration Aged over 18 years old Willingness to give written informed consent, willingness to complete a magnetic resonance imaging study, complete various questionnaires and to have a blood sample taken
Exclusion criteria
Taking daily analgesic medications such as aspirin, ibuprofen, gabapentin, serotonin reuptake inhibitors, anti-depressants for any conditions within 24 hours of study initiation. Claustrophobia Standard MRI exclusion criteria such as the presence of a cardiac pacemaker, artificial heart valve, blood vessel stents, aneurysm clips, cochlear implants, prosthetic devices, magnetically activated implant or device and pregnancy. History of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.
Outcome results
None listed