The role of sensory parameters in predicting clinical outcome after lumbar discectomy

• Register: ANZCTR
• Last refreshed on: 2 November 2020
• Main ID: ACTRN12614001070628
• Date of registration: 07/10/2014
• Prospective Registration: No
• Primary sponsor: Dr Brigitte Tampin
• Public title: The role of sensory parameters in predicting clinical outcome after lumbar discectomy
• Scientific title: The role of quantitative sensory testing parameters in predicting clinical outcome in patients undergoing lumbar discectomy
• Date of first enrolment: 30/09/2014
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614001070628.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Case control;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Brigitte Tampin

• Name: Dr Brigitte Tampin

Key inclusion & exclusion criteria

Inclusion criteria: Age 18 to 65 years; symptom duration of > 3 months; clinical diagnosis of lumbar radiculopathy (defined as conduction block along a spinal nerve or nerve root, manifesting clinically with dermatomal sensory loss or myotomal weakness or reflex changes) and leg pain in L5 or S1 dermatomal distribution; demonstrable clinically relevant abnormality on imaging studies indicating nerve root compression at the relevant spinal level; person listed on the elective neurosurgery surgery waitlist for the procedure of lumbar discectomy.
Exclusion criteria: diabetes and vascular disease, thyroid disorder, other neurological or psychiatric disease; previous lumbar surgery; a history of any disorders that potentially might affect the sensation in the hand (negative control site) to be tested and an insufficient level of English to understand and fill out the questionnaires

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Lumbar radiculopathy with radicular pain;
Lumbar radiculopathy with radicular pain

Surgery - Other surgery

Neurological - Other neurological disorders

Intervention(s)

The initial participant assessment will be performed in the week prior to surgery. The once-off baseline assessment will take approximately 2.5 hours.
Standardised quantitative sensory testing (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.

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 dermatomes (L5 or S1). Testing of the full QST protocol will take approximately 30 minutes per test area. Testing of the dermatomal detection thresholds will take less than 10 minutes.

In addition the following measurements will be taken either in interview format or via questionnaires at the initial assessment before surgery:
*Duration of pain
*Pain intensity of back and leg pain
*Health care utilisation
*Bothersomeness of back and leg pain
*Confidence in recovery (‘great deal’, ‘moderate’, ‘no confidence’, ‘do not know’)
*Intake of medication
*Sleep quality (Visual Analogue Scale)
*Duration of inability to work
*Functional status (Oswestry Disability Index)
*Anxiety and Depression (Hospita

Primary Outcome(s)

Oswestry Disability Index[3 months and 12 months post surgery]

Pain intensity (NRS -11)[3 and 12 months post surgery]

Secondary Outcome(s)

QST maximal pain area and dermatome
[3 months post surgery]

Health care utilisation ; outcome assessed by questionnaire:
Q: What treatment options have you accessed in the past 4 weeks for your pain condition? Several health professionals are given as answer, plus participant has to indicate the number of times visited. There is no data linkage to medical records,.[3 and 12 months post surgery]

Bothersomenes of back and leg pain ;
Q: how bothersome has your back/leg pain been in the last 2 weeks? Answer: not at all, slightly, moderately, very much, extremely[3 and 12 months post surgery]

pain descriptors (painDETECT)[ 3 and 12 months post surgery]

Return to work (yes/no) (any work:full time, part time or casual)[3 and 12 months post surgery]

Health related quality of life (SF-36)
[3 and 12 months post surgery ]

Medication intake ; assessed by questionnaire - participant has to write down name of current medication, dosage and reason for taking this medication[3 and 12 months post surgery]

Patient Global Impression of Change Scale [3 and 12 months post surgery]

Secondary ID(s)

nil

Source(s) of Monetary Support

Government of Western Australia, Department of Health

Charlies Foundation for Research; Sir Charles Gairdner and Osborne Park Health Care Group Research Advisory Committee

Raine Medical Research Foundation

Sir Charles Gairdner and Osborne Park Health Care Group Research Advisory Committee

Ethics review

Status: Approved
Approval date: 07/08/2014
Contact:

Sir Charles Gairdner Group Human Research Ethics Committee