Assessment of nerve-related pain and altered nerve function in patients with sciatica

Not Applicable

Recruiting

• Conditions: Neurological - Other neurological disorders; umbar radicular pain; Public Health - Other public health; Lumbar radicular pain

• Registration Number: ACTRN12614000315617
• Lead Sponsor: Brigitte Tampin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-25
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients: symptom duration of > 3 months; radicular leg pain in L5 or S1 dermatomal distribution; intensity of leg pain is higher than intensity of low back pain
Healthy control group: Subjects with a history of current pain or a chronic pain condition or any of the exclusion criteria described for the patient group will be excluded, including taking medications that influence pain perception (e.g. analgesics, non-steroidals, antidepressants).

Exclusion Criteria

diabetes, vascular disease; other neurological or psychiatric disease; a history of any previous disorders that potentially might affect the sensation in the contralateral side and in the hand (negative control site) to be tested and an insufficient level of English to understand and fill out the questionnairesa.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensory parameters;To compare and illustrate patients’ QST data profiles with the group mean of age-matched healthy controls (HC) patients’ data will be z-transformed for each single parameter by using the following expression: Z-score = (Mean single proband – Mean healthy controls)/SD healthy controls. Z-values will be calculated based on the included HC group data. Differences of z-score QST data between the patient group and HC and tested body regions will be compared using a two-way analysis of covariance (ANCOVA) with tested body areas (maximal pain area, hand) as the within-subjects factor.<br>Bedside sensory alterations will be compared to z-transformed QST data in relation to HC data (2 standard deviation above mean). Correlation analysis will be used to analyse associations between QST measures and 3 and 12 months follow-up measurements.[at initial assessment]

Secondary Outcome Measures

Name	Time	Method
Functional status at 3 months and 12 months using Oswestry Disability Index [3 months and 12 months after initial assessment];Pain intensity and pain desriptors using painDETECT[3 and 12 months after initial assessment]