Neuropathic Pain Caused by Lumbar Radicular Pain Clinical Trial
— EMONOfficial title:
Effect of Minocycline on Neuropathic Pain
| Verified date | January 2015 |
| Source | Ziekenhuis Oost-Limburg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
The purpose of this study is to determine if minocycline is effective in the treatment of neuropathic pain. The effect of minocycline will be compared to the effect of placebo and amitriptyline.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: Lumbar radicular pain due to disc herniation, failed back surgery syndrome or spinal canal stenosis causing neuropathic pain Exclusion Criteria: 1. Diabetic, alcoholic or drug induced polyneuropathies 2. Depression or psychiatric comorbidity affecting pain sensation. 3. Use of antidepressants 4. Fibromyalgia and Chronic Fatigue Syndrome 5. Pregnancy. 6. Previous spinal cord damage 7. Malignancies 8. Allergy to minocycline or amitriptyline |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ziekenhuis Oost-Limburg | Genk | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Ziekenhuis Oost-Limburg |
Belgium,
Bastos LF, de Oliveira AC, Watkins LR, Moraes MF, Coelho MM. Tetracyclines and pain. Naunyn Schmiedebergs Arch Pharmacol. 2012 Mar;385(3):225-41. doi: 10.1007/s00210-012-0727-1. Epub 2012 Jan 27. Review. — View Citation
Sumracki NM, Hutchinson MR, Gentgall M, Briggs N, Williams DB, Rolan P. The effects of pregabalin and the glial attenuator minocycline on the response to intradermal capsaicin in patients with unilateral sciatica. PLoS One. 2012;7(6):e38525. doi: 10.1371/ — View Citation
Vanelderen P, Rouwette T, Kozicz T, Heylen R, Van Zundert J, Roubos EW, Vissers K. Effects of chronic administration of amitriptyline, gabapentin and minocycline on spinal brain-derived neurotrophic factor expression and neuropathic pain behavior in a rat — View Citation
Zhang Q, Peng L, Zhang D. Minocycline may attenuate postherpetic neuralgia. Med Hypotheses. 2009 Nov;73(5):744-5. doi: 10.1016/j.mehy.2009.04.028. Epub 2009 May 24. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Concentration of brain-derived neurotrophic factor (BDNF) in serum and plasma | A blood sample (10ml) will be taken at baseline and after 14 days medication intake. The concentration of brain derived neurotrophic factor will be determined by high sensitivity ELISA (R&D systems® Europe, United Kingdom; detection range: 20-4,000 pg/ml) and the change in BDNF-concentration in serum and plasma between baseline and day 14 will be evaluated. | Baseline (before start of study) and after 14 days of medication intake. | No |
| Primary | Pain intensity | Pain intensity will be measured using a visual analogue scale and the change in pain intensity between baseline and day 7, day 7 and day 14, baseline and day 14 will be evaluated | Baseline (before start of study), 7 and 14 days after start of medication intake | No |
| Secondary | neuropathic pain diagnostic questionnaire (DN4) score | The DN4 questionnaire is used to assess the neuropathic symptoms of the pain and the change in DN4 score between baseline and day 7, day 7 and day 14, baseline and day 14 will be evaluated | Baseline (before start of study), 7 and 14 days after medication intake | No |
| Secondary | Amount of rescue medication taken | Rescue medication consists of tramadol 50mg by mouth 3-times daily if necessary. Patients will be provided with a total of 42 tablets of tramadol 50mg for the duration of the study. The remaining rescue medication will be counted on day 7 and day 14 and the change in rescue medication intake between baseline and day 7, day 7 and day 14, baseline and day 14 will be evaluated | 7 and 14 days after medication intake | No |