Correlation study of genetic variations with the pregabalin as analgesic in patients with chronic low back pain.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001649404
• Date of registration: 29/11/2016
• Prospective Registration: Yes
• Primary sponsor: Aristotle University of Thessaloniki, Greece
• Public title: Correlation study of genetic variations with the pregabalin as analgesic in patients with chronic low back pain.
• Scientific title: Correlation study of polymorphisms in genes SLC7A5 and SLC22A4 with the pregabalin efficacy and safety in patients with chronic low back pain.
• Date of first enrolment: 15/12/2016
• Target sample size: 200
• Recruitment status: Withdrawn
• URL: https://anzctr.org.au/ACTRN12616001649404.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Greece

Contacts

• Name: Dr Maria Zouka

• Name: Dr Antonios Goulas

Key inclusion & exclusion criteria

Inclusion criteria: 1.Age 18-79 years
2.Patients with lumbar radicular pain for more than three months
3.Patients with disc prolapse, spinal stenosis or failed surgery in the lumbar spine
4.Patients with neuropathic pain which is certified both by the discovery of nerve damage points as weakness, numbness, hyperalgesia, allodynia and with a NRS score larger that 4/10.
Exclusion criteria: 1. Pain in the lumbar region stronger than the radicular pain
2. Significant motor deficits / disorders in urine bladder or bowel
3. Known depression with or without antidepressant treatment
4. Background of addiction or abuse
5. Current treatment with gabapentin, pregabalin or opioids
6. Diabetic or postherpetic neuropathy
7. Renal insufficiency, diabetes, congestive heart failure, thrombocytopenia.
8. Use of ACE inhibitors

Age minimum: 18 Years
Age maximum: 79 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Pain management

Chronic low back pain;
Chronic low back pain

Intervention(s)

Patients meeting the inclusion criteria will be informed of the purpose of the study and included in this after written consent which includes the consent to a blood sample for genomic testing.
Patients should make an initial assessment. During the initial assessment will assess pain intensity, functional impairment and sleep disturbance.
Thereafter patients should start their treatment, which reads as follows: The first week will take oral tablet Pregabalin dose to 25 mg twice daily followed by oral tablet Paracetamol at a dose of 1 gr twice daily. At the end of the week, patients will be assessed either in person or via telephone questionnaire. The parameters which will be evaluated by the pain intensity sleep quality, the functional impairment and the presence of serious side effects. Regarding side effects, we will first record the incidence of the most common of them, namely peripheral oedema,, dizziness, drowsiness, headache and fatigue, weight gain and dry mouth, horror, blurred vision and diplopias. At the same time these reactions will be evaluated and considered as serious on the basis of either the judgment of the therapist or the patient's discomfort as likely to require treatment discontinuation or dose reduction. If serious adverse reactions occur, patients should discontinue treatment with Pregabalin and will be excluded from the study.
Patients that will not appear any serious side effects will pass to the second phase of the study where the dosage of oral tablet pregabalin will be increased to 75 mg twice daily, followed by administering oral tablet paracetamol 1 g twice daily. Similarly those patients will be reassessed one week after starting this regimen for the parameters of the intensity of pain, function, sleep and side effects. If adve

Primary Outcome(s)

Correlation of the total requirements for pregabalin (mg/kg/day) with SLC22A4 and SLC7A5 gene polymorphisms (assessed by serum assay).
Pregabalin total requirements will be assessed according to the prescribed therapy that every patient followed[Once a week during patients' therapy with pregabalin]

Correlation of gene polymorphisms with the subjective sensation of pain.
For the assessment of postoperative pain the NRS (Numerical Rating Scale) and BPI (Brief Pain Inventory) scales will be used.[Once a week during patients' therapy with pregabalin]

Secondary Outcome(s)

Correlation of gene polymorphisms with sleep quality using the Pittsburgh Sleep Quality Index questionnaire (PSQI) and Epworth Sleepiness Scale (ESS)[Once a week during patients' therapy with pregabalin]

Correlation of the gene polymorphisms with their ability to tolerate the escalation in pregabalin treatment
The tolerance will be assesed with the adverse effects of pregabalin.
As adverse effects of pregabalin are considered patients clinical symptoms of peripheral oedema, dizziness, drowsiness, headache and fatigue, weight gain and dry mouth, blurred vision and diplopia[Once a week during patients' therapy with pregabalin]

Correlation of gene polymorphisms with functionality using the questionnaire Low Back Pain Disability Questionnaire[Once a week during patients' therapy with pregabalin]

Correlation of the gene polymorphisms with the need for pregabalin discontinuation or dose reduction due to serious adverse events.
Adverse effects will be considered as serious on the basis of either the judgment of the therapist or the patient's discomfort.[Once a week during patients' therapy with pregabalin]

Secondary ID(s)

None

Source(s) of Monetary Support

Aristotle University of Thessaloniki, Greece

Ethics review

Status: Approved
Approval date:
Contact:

Bioethics Committee of Medical School. Aristotle Univeristy of Thessaloniki, Greece

Status: Approved
Approval date:
Contact:

Scientific Committee of General University Hospital of Thessaloniki, AHEPA