PRECISE, a two arm, double blind randomised controlled trial of pregabalin in addition to usual care compared to placebo with usual care for reducing leg pain in patients with sciatica.

The George Institute for Global Health0 个研究点目标入组 204 人开始时间: 2013年5月13日最近更新: 2020年1月13日

适应症

试验速览

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•Eligible participants will meet all of the following criteria:
•Radiating pain into one leg below the knee.
•Nerve root/spinal nerve involvement evidenced by at least one of the following clinical features:
•a) Myotomal weakness,
•b) Dermatomal sensory deficits,
•c) Diminished reflexes,
•d) Leg pain radiating in a dermatomal distribution.
•Leg pain severe enough to cause at least moderate pain or moderate interference with normal work or daily activities over the last week (measured by adaptations of items 7 and 8 in the SF-36 questionnaire).
•Pain duration of current episode of at least 1 week and up to 1 year.
•Age 18 years and over.
•Sufficient understanding of the English language or interpretation assistance available to complete the study treatment and assessments.

•Patients will be excluded if they meet any of the following criteria:
•Known or suspected serious spinal pathology (e.g. cauda equina syndrome, spinal fracture).
•Pregnant or breastfeeding women, and males or females planning conception during the 8 week treatment period.
•Scheduled or being considered for spinal surgery or interventional procedures for sciatica during the 8 week treatment period.
•Contraindications to pregabalin (known allergy to pregabalin or significant renal impairment. Pregabalin is predominantly renally excreted, so patients with an estimated creatinine clearance of < 60 ml/min will be excluded).
•Already taking an anticonvulsant medication, a medication for neuropathic pain, a tricyclic antidepressant or a sedative and unable to cease the medication.

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