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Trial registered on ANZCTR


Registration number
ACTRN12614000315617
Ethics application status
Approved
Date submitted
15/03/2014
Date registered
25/03/2014
Date last updated
11/07/2019
Date data sharing statement initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of nerve-related pain and altered nerve function in patients with sciatica
Scientific title
Assessment of neuropathic pain and altered sensory nerve function in patients with lumbar radicular pain, using quantitative sensory testing and bedside examination
Secondary ID [1] 284271 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar radicular pain 291402 0
Condition category
Condition code
Neurological 291763 291763 0 0
Other neurological disorders
Public Health 291796 291796 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Quantitative sensory testing (QST): Standardised QST will be performed according to the QST protocol of German Research Network on Neuropathic pain. The protocol includes the following assessments: cold and warm detection thresholds; the number of paradoxical heat sensations during the procedure of alternating warm and cold stimuli; cold and heat pain thresholds; mechanical detection threshold; mechanical pain threshold; stimulus-response functions: mechanical pain sensitivity and dynamic mechanical allodynia; wind-up ratio; vibration detection threshold and pressure pain threshold.
The clinical assessment tool, Standardized Evaluation of Pain (StEP), used for the identification of neuropathic pain in patients with lumbar radiculopathy, will be applied. The tool consists of a short interview and bedside sensory examination including: assessment of light touch and vibration sense, thermal, pinprick and pressure sensitivity and straight leg raise testing.
QST measurements will be taken from the main pain area nominated by the patient, as required for the assessment of neuropathic pain, and the contralateral side and from the ipsilateral hand dorsum as a remote control site, plus thermal and mechanical detection thresholds will be assessed in the relevant dermatome (L5, S1) on the symptomatic side.
QST and bedside sensory examination will be administered just once.
Participants will be followed up by questionnaires at 3 months and 12 months after initial assessment






Intervention code [1] 288980 0
Not applicable
Comparator / control treatment
comparison to healthy control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291692 0
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.
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.
Timepoint [1] 291692 0
at initial assessment
Secondary outcome [1] 307302 0
Functional status at 3 months and 12 months using Oswestry Disability Index
Timepoint [1] 307302 0
3 months and 12 months after initial assessment
Secondary outcome [2] 307346 0
Pain intensity and pain desriptors using painDETECT
Timepoint [2] 307346 0
3 and 12 months after initial assessment

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In a previous study of the applicant the sample size of 23 patients was sufficient to detect significant differences in nerve fibre dysfunction between sides and between patients and health controls (published in PAIN 2012, 153 (12), 2403-2414). Sample size calculation had been based on data from the German Research Network on Neuropathic pain where a sample size of 25 would be sufficient to detect a clinically significant difference in pressure pain thresholds of 36% between groups and between the symptomatic and asymptomatic arm with a power of 80% and 5% level of significance. The number of healthy control (HC) subjects to be tested has to be determined during the course of the study, as reference data have to be obtained from at least 8 male and 8 female HC subjects for each maximal pain area nominated by the patients. It is anticipated that 4 body regions may be nominated as maximal pain area (thigh L5 and S1 distribution, lower leg L5 and S1 distribution), resulting in likely 32 HC to be recruited.
Stat analyses: Quantitative sensory testing (QST) data will be log-transformed prior to statistical analysis except those data which are normally distributed as raw data. To compare and illustrate patients’ QST data profiles with the group mean of age-matched healthy controls 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. Group (patients/controls)will be entered as between-subjects factors. Anxiety, depression and fear avoidance scores will be entered as covariates to account for potential influence of these factors on pain responses. 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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2191 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 7868 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 288893 0
University
Name [1] 288893 0
School of Physiotherapy and Exercise Science, Curtin University
Address [1] 288893 0
PO Box U1987
Perth WA 6845
Country [1] 288893 0
Australia
Funding source category [2] 300274 0
Hospital
Name [2] 300274 0
Sir Charles Gairdner and Osborne Park Health Care Group Research Advisory Committee
Address [2] 300274 0
Research Advisory Committee, Department of Research,
Level 2, A Block, Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, Western Australia 6009
Country [2] 300274 0
Australia
Funding source category [3] 300275 0
Hospital
Name [3] 300275 0
Sir Charles Gairdner and Osborne Park Health Care Group Research Advisory Committee
Address [3] 300275 0
Research Advisory Committee, Department of Research,
Level 2, A Block, Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, Western Australia 6009
Country [3] 300275 0
Australia
Primary sponsor type
Individual
Name
Brigitte Tampin
Address
Sir Charles Gairdner Hospital
Neurosurgery Spinal Clinic
Pain Management Department
G Block, Lower Ground Floor
Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 287590 0
None
Name [1] 287590 0
none
Address [1] 287590 0
Country [1] 287590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290726 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 290726 0
Sir Charles Gairdner Hospital
Level 2 A Block
Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 290726 0
Australia
Date submitted for ethics approval [1] 290726 0
Approval date [1] 290726 0
26/11/2013
Ethics approval number [1] 290726 0
2013-098

Summary
Brief summary
Low back pain is one of the most common health problems and affects 80 – 85% of people over their life time. Low back-related leg pain or sciatica is a common variation of low back pain. Although the prognosis for sciatica is good in most patients, up to 30% of patients continue to have pain for 1 year or longer. People with sciatica may or may not present with signs of nerve damage and associated nerve-related pain (neuropathic pain). It is important to determine the presence of altered nerve function as this (i) may contribute to people having persistent pain and/or disability and both are associated with greater health costs and poorer patient outcomes; (ii) will help direct more targeted treatment for the underlying condition such as specific pharmaceutical intervention for the treatment of neuropathic pain or surgical intervention in case of nerve root compromise. Targeted treatment may prevent the transition to persistent pain and associated poorer health outcomes and greater health economic burden.

This study will investigate responses to various sensory stimuli (to heat and cold, to light touch and pressure, to pin-prick and vibration) that can be used to assess nerve fibre dysfunction. We will explore the correspondence of quantitative laboratory sensory testing with simple bedside sensory testing in patients with sciatica and compare findings with a healthy population that is age and gender matched. Should the bedside examination findings match the laboratory findings, then bedside examination may potentially replace time-consuming laboratory testing in the future. We will also investigate if sensory examination findings may be associated with the persistency of pain and functional status at 3 and 12 months follow-up in patients with sciatica.

It is anticipated that there will be sub-groups of patients with differing sensory profiles. Sensory profiles of enhanced pain sensitivity will be associated with pain persistency and functional status at 3 and 12 months follow-up. The outcome of the study will inform clinical pathways to optimise time and cost efficient health outcomes for this patient cohort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46978 0
Dr Brigitte Tampin
Address 46978 0
Sir Charles Gairdner Hospital
Neurosurgery Spinal Clinic
Pain Management Department
G Block, Lower Ground Floor
Hospital Avenue
Nedlands WA 6009
Country 46978 0
Australia
Phone 46978 0
+61 8 6457 7964
Fax 46978 0
+61 8 6457 3481
Email 46978 0
Brigitte.Tampin@health.wa.gov.au
Contact person for public queries
Name 46979 0
Dr Brigitte Tampin
Address 46979 0
Sir Charles Gairdner Hospital
Neurosurgery Spinal Clinic
Pain Management Department
G Block, Lower Ground Floor
Hospital Avenue
Nedlands WA 6009
Country 46979 0
Australia
Phone 46979 0
+61 8 6457 7964
Fax 46979 0
+61 8 64573481
Email 46979 0
Brigitte.Tampin@health.wa.gov.au
Contact person for scientific queries
Name 46980 0
Dr Brigitte Tampin
Address 46980 0
Sir Charles Gairdner Hospital
Neurosurgery Spinal Clinic
Pain Management Department
G Block, Lower Ground Floor
Hospital Avenue
Nedlands WA 6009
Country 46980 0
Australia
Phone 46980 0
+61 8 6457 7964
Fax 46980 0
+61 8 6457 3481
Email 46980 0
Brigitte.Tampin@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results