None listed
Conditions
Brief summary
Sciatica or sciatic neuralgia, a common form of lumbosacral radiculopathy, is characterized by low back pain that radiates to the leg below the knee and can be accompanied by sensory loss, motor weakness and reflex abnormalities. Sciatica is considered to be a prognostic indicator of poor outcome among patients with low back pain with a substantial proportion continuing to have persistent pain for two years or longer. The annual prevalence of sciatica is estimated to be between 14% and 2%. While guidelines provide clear and generally consistent recommendations for the prescription of drugs for non-specific low back pain this is not the case for sciatica. Patients with a clinical diagnosis of sciatica are about five times more likely to take drugs than those with low back pain only, with analgesic and adjuvant pain drugs being the mainstay of current treatment. The efficacy of these prescribed medications is varied and conflicting in this population. Gabapentin and Pregabalin represent a newer approach to the treatment of sciatica. Both are analgesics of GABA that modulate the calcium-channel subunits, possibly decreasing the neurotransmitter release associated with the central sensitization that occurs in sciatica. With the recent PBS listing of Pregabalin for neuropathic pain refractory to treatment with other drugs, we hypothesize pregabalin to be superior to gabapentin in reduction of pain for patients suffering sciatica. This head to head clinical trial will examine the effects of both agents in treating pain associated with sciatica compared to placebo in a randomised controlled setting.
Interventions
Sequence 1 = Pregabalin capsules 150mg – initially 1 capsule daily for 1 week increasing to 1 capsule three times a day for 1 week then increase to 2 capsules three times a day thereafter. Treatment duration will be 8 weeks in total with drug tablet returns to be used to monitor compliance along with accountability logs. This will be followed by a 1 week washout period and then Gabapentin 400mg capsules in the identical titration method for a further 8 weeks treatment.
Sponsors
The Townsville Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
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
18 years or older Diagnosis of sciatica First presentation to the pain clinic for intervention treatment Patients with continuous sciatica for over 3 months, with a corresponding physical cause proven on CT or MRI, will be considered.
Exclusion criteria
Pregnant or breastfeeding Prior treatment with pregabalin and or gabapentin Clinically relevant medical/psychological illness which might affect study participation Creatinine clearance <60ml/min Taking antiepileptics, nerve blocks muscle relaxants, anticonvulsants, mexiletine, topical analgesics, or antiviral agents. Patient history or laboratory results that suggested the presence of an inherited neuropathy or neuropathy attributable to other causes, such as hypothyroidism, vitamin B12 deficiency, connective tissue disease, amyloidosis, and toxic exposure Major organ system disease, cardiovascular autonomic neuropathy, baseline postural hypotension of more than 20 mm Hg, sedation or ataxia due to concomitant drugs or other cause, urinary symptoms attributable to benign prostatic hypertrophy in male participants, psychiatric or substance abuse disorder, hypersensitivity to any of the study drugs, or a coexisting disorder causing pain as severe as the neuropathic pain.
Outcome results
None listed