Pregabalin and Orofacial Neuropathic Pain
Information source: University of Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain; Orofacial Pain
Intervention: pregabalin (Drug); placebo (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: University of Toronto Official(s) and/or principal investigator(s): Thuan Dao, PhD, Principal Investigator, Affiliation: University of Toronto
Summary
The purpose of this study is to determine whether pregabalin can decrease pain and improve
quality of life in patients who have nerve pain on the mouth or the face
Clinical Details
Official title: Efficacy of Pregabalin in the Treatment of Orofacial Neuropathic Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain intensity
Secondary outcome: Pain unpleasantnessQuality of life using the modified short form of Oral health Impact Profile Anxiety and Depression measured with the Hospital Anxiety and Depression Rating scae Patient global impression of change Proportion of patients with 30% and 50% reduction of pain Side effects
Detailed description:
Neuropathic pain (NP) is defined as pain initiated or caused by a primary lesion or
dysfunction in the nervous system. At the trigeminal area where somatosensory nerves are
often damaged during dental /maxillofacial interventions, post-operative orofacial
neuropathic pain (OFNP) estimated treated prevalence/incidence rates were ~3-12%, with 83%
of patients reporting that OFNP started with a dental treatment. Although OFNP is a burden
for the society, and a major cause of chronic distress, disability and expenditure of
medical resources, clinical trials that assess efficacy of its treatment are scarce. Until
today, treatments of OFNP are extrapolated from those issued for neuropathic pain in other
body sites. This clinical trial will be the first to evaluate the efficacy, safety, and
tolerance of pregabalin in the treatment of OFNP. Based on the results obtained for
neuropathic pain on non trigeminal areas, we expect to see positive results, and to provide
evidence for effective management of OFNP with an anticonvulsant such as pregabalin.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients 18 years of age or older, males and females
- history of dental and/or maxillofacial treatment/surgery that may cause nerve injury
(e. g. root canal treatment, implant placement, deep restorations, tooth extractions,
injection of anesthetics)
- patients who score 12 on the validated self-report version of the Leeds Assessment of
Neuropathic Symptoms and Signs pain scale (S-LANSS; Bennett et al. 2005) for
extra-oral sites, or 9 for intra-oral sites (the scoring for extra-oral sites is
taken as suggested; for intra-oral sites, the 5-point scoring for question 2 has
been removed and the score proportionally adjusted, since it is difficult for
patients to see color changes in their mouth)
- pain rated 4 or more on a numerical scale (0 being no pain, 10 being the most intense
pain imaginable), on a daily basis
- pain lasting more than 6 months
- absence of identifiable organic lesion, inflammation or infection
- normal serum creatinine
- reports that current and previous pain medications failed to provide adequate relief
(e. g., analgesic, non-steroidal anti-inflammatories, opioids, antidepressants)
- if currently using medication, acceptance of a wash-out period of at least one week,
during which only Tylenol can be used as rescue medication
- able to use the Palm handheld device to report daily pain
Exclusion Criteria:
- lactating, pregnancy (potentially child bearing patients need to have a referral from
family physician stating that the patient is not expecting or to be using
contraception)
- renal impairment or renal failure (contra-indication to pregabalin)
- congestive heart failure or liver disease
- currently suffering from trigeminal neuralgia
- history of mental disorder, widespread pain or other severe pain conditions that may
confound the pain assessment (e. g. depression, chronic fatigue, migraine headaches,
fibromyalgia, severe chronic pain conditions)
- intolerance or allergy to gabapentin and pregabalin
Locations and Contacts
Dr. P. Watson's office, Etobicoke, Ontario M9V 4B8, Canada
University of Toronto, Toronto, Ontario M5G1G6, Canada
Additional Information
Starting date: February 2009
Last updated: June 1, 2015
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