PRECISE: pregabalin in addition to usual care for sciatica.
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 Health
204 participants
Sep 3, 2013
Interventional
Conditions
Summary
Patients with sciatica experience low back pain, with pain radiating into the leg and possible neurological deficits. Sciatica is associated with substantial pain and chronic disability. The lack of evidence supporting effective treatments for sciatica makes clinical management difficult. The aim of the study is to determine the efficacy and cost effectiveness of adding pregabalin to usual care for reducing leg pain intensity in patients with sciatica. PRECISE is a prospectively registered, double blind, randomized placebo controlled trial of pregabalin, in addition to usual care in people with sciatica. Participants will be recruited from patients in the community who consult a study general practitioner (GP) or medical specialist (e.g. orthopaedic surgeon, neurosurgeon, neurologist or rheumatologist) with moderate to severe sciatica. GPs and specialists will be recruited from the Sydney metropolitan area (Australia). Other referral sources include physiotherapists and chiropractors that may identify potential participants and then refer the patient to a study GP. Participant inclusion criteria include low back pain that radiates below the knee, neurological compromise, interference with normal daily activities and pain duration of 1 week to 1 year. Participants will not be eligible if they are scheduled for spinal surgery, have known serious pathology, are pregnant, have contraindications to pregabalin or taking certain prescribed medicines. Participants will be randomised to receive either pregabalin with usual care (n=102) or the placebo with usual care (n=102) for 8 weeks. The medicine dosage will be titrated up to the participant’s optimal dose, to a maximum 600 mg per day. Usual care, if deemed appropriate by the study doctor may include analgesic medication or physical and manual therapy. Participants, doctors and researchers collecting participant data will be blinded. The primary outcome is leg pain. Secondary outcomes include back pain, disability and quality of life. Treatment effectiveness analysis will be blinded and by intention-to-treat. A p-value of < 0.05 will be considered statistically significant. A parallel economic evaluation will be conducted from the societal perspective.
Eligibility
Inclusion Criteria11
- 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.
Exclusion Criteria6
- 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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Interventions
Arm 1 pregabalin plus usual care. Pregabalin is a drug to treat neuropathic pain. Initial dose of 150mg/day, divided over 2 dosed and may be increased to a maximium dose of 600mg/day with gradual titration over a four week period. Discontinuation is to reduce the dose over >7 days. It is administered in capsule form. The participants will be monitored over the 8 week treatment by a study doctor period.The study doctor will amend the dosage based on the patient’s ‘adequate improvement’ to the study medicine. Adequate improvement is defined as a pain rating of 0 or 1 out of 10, for leg pain, for a minimum of 72 hours, with none or tolerable side effects. If ‘adequate improvement’ has not occurred, the study doctor may increase the study medicine dosage. If ‘adequate improvement’ is reported, the dose can remain the same until the end of the study. The maximum tolerated dose for each participant will be maintained for 4 weeks or up to ‘adequate improvement’or if achieved before the 8 week standard treatment regimen is completed, early titration down to cessation. All patients will be titrated down to cessation to complete the study treatment period. In addition to receiving the study medicines and advice (patient reassurance, staying active and avoiding bed rest) participants will receive usual care. This can consist of physical or manual therapies and other analgesic medications (except adjuvant analgesics), if deemed appropriate by the study doctor. The total invention time is 8 weeks. The follow up includes up to 9 participant consultations with the study doctor study to begin treatment, monitor progress and adjust the dose of the study medication. Outcomes measures will be collected at baseline and weeks 2, 4, 8, 12, 26 and 52. Adherence will be achieved through study doctor training, participant consultations, data collected from the participant by research assistants. Procedures for monitoring adherence include Adherence to study medication will be documented through a self-reported daily medication diary and by counting the returned medicine, compared to the prescribed regimen as recorded by the study doctor. Participants will be asked to return unused medicines via a reply paid post satchel at the end of the 8-week treatment period.
Locations(1)
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ACTRN12613000530729