PRECISE: pregabalin in addition to usual care for sciatica.

Phase 4

Completed

• Conditions: Sciatica; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12613000530729
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average leg pain intensity over the last 24 hours measured by the numeral pain rating scale.<br><br>[Time point: baseline, week 2, 4, 8, 12, 26, 52.]

Secondary Outcome Measures

Name	Time	Method
Back pain intensity using the Numerical Pain Rating Scale. [Time point: baseline and weeks 2, 4, 8, 12, 26 and 52.];Disability by the Roland Disability Questionnaire for Sciatica.[Time point: baseline and weeks 2, 4, 8, 12, 26 and 52.];Quality of Life (SF-12v2) questionnaire. [Time point: baseline and weeks 2, 4, 8, 12, 26 and 52.];Global Perceived Effect, which asks the participant to compare their leg pain to when this episode of sciatica first started. [Time point: baseline and weeks 2, 4, 8, 12, 26 and 52.];Work and health utilization questions to report the use of health services and amount of hours missed from paid employment because of sciatica. [Time point: baseline and weeks 4, 12, 26 and 52. ]