PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a
randomised controlled trial.
Author(s): Mathieson S(1), Maher CG, McLachlan AJ, Latimer J, Koes BW, Hancock MJ, Harris I,
Day RO, Pik J, Jan S, Billot L, Lin CW.
Affiliation(s): Author information:
(1)The George Institute for Global Health and Sydney Medical School, University of
Sydney, PO Box M201, Missenden Rd, Camperdown, Sydney, NSW 2050, Australia.
clin@georgeinstitute.org.au
Publication date & source: 2013, Trials. , 14:213
BACKGROUND: Sciatica is a type of neuropathic pain that is characterised by pain
radiating into the leg. It is often accompanied by low back pain and neurological
deficits in the lower limb. While this condition may cause significant suffering
for the individual, the lack of evidence supporting effective treatments for
sciatica makes clinical management difficult. Our objectives are to determine the
efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness
in patients with sciatica.
METHODS/DESIGN: PRECISE is a prospectively registered, double-blind, randomised
placebo-controlled trial of pregabalin compared to placebo, in addition to usual
care. Inclusion criteria include moderate to severe leg pain below the knee with
evidence of nerve root/spinal nerve involvement. Participants will be randomised
to receive either pregabalin with usual care (n = 102) or 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. Follow up consultations
will monitor individual progress, tolerability and adverse events. Usual care, if
deemed appropriate by the study doctor, may include a referral for physical or
manual therapy and/or prescription of analgesic medication. Participants, doctors
and researchers collecting participant data will be blinded to treatment
allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12,
26 and 52. The primary outcome will determine the efficacy of pregabalin in
reducing leg pain intensity. Secondary outcomes will include back pain intensity,
disability and quality of life. Data analysis will be blinded and by
intention-to-treat. A parallel economic evaluation will be conducted from health
sector and societal perspectives.
DISCUSSION: This study will establish the efficacy of pregabalin in reducing leg
pain intensity in patients with sciatica and provide important information
regarding the effect of pregabalin treatment on disability and quality of life.
The impact of this research may allow the future development of a cost-effective
conservative treatment strategy for patients with sciatica.
TRIAL REGISTRATION: ClinicalTrial.gov, ACTRN 12613000530729.
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