Research into the changes of immune cells in spinal fluid after treatment with amitriptyline and spinal cord stimulation in neuropathic pai

Not Applicable

Completed

• Conditions: Chronic lumbar radicular pain, failed back surgery syndrome, complex regional pain syndrome; Signs and Symptoms

• Registration Number: ISRCTN70120536
• Lead Sponsor: St James's Hospital / Trinity College Dublin

Brief Summary

2021 Results article in https://doi.org/10.1016/j.bbih.2020.100184 (added 11/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-12
• Study Completion: 2018-03-30
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Amitriptyline study:
1. Patients aged 20 – 65 years with lumbar radicular pain
2. Clinical and radiological evidence of one nerve root and/or dermatome affected

Neuromodulation study:
1. Patients aged 20 – 65 years with FBSS or CRPS who have been implanted with a spinal cord stimulator

Exclusion Criteria

Amitriptyline study:
1. Patient refusal
2. Anticoagulant medication
3. Infection
4. Pregnancy
5. Breastfeeding
6. Corticosteroid therapy
7. Stroke
8. Psychiatric history
9. History of ischaemic heart disease
10. Arrhythmia
11. Heart block
12. Cerebral impairment
13. Current anti-neuropathic medication
14. Biologic medication

Neuromodulation study:
1. Patient refusal
2. Anticoagulant medication
3. Infection
4. Pregnancy
5. Breastfeeding
6. Corticosteroid therapy
7. Stroke
8. Psychiatric history
9. Cerebral impairment
10. Biologic medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Frequency of neuroimmune cells CD4+ T Cell, CD8+ T Cells, and Natural Killer cells in the cerebrospinal fluid, assessed by flow cytometry before and after treatment with amitriptyline (study 1) and spinal cord stimulation (study 2).<br><br> The exact date after recruitment will be after at least 2 weeks for reflection. With study 1 the second sample will be taken 6-8 weeks after treatment with amitriptyline. In study 2 the second sample will be taken after 2 weeks of neuromodulation.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Changes in neuropeptides and cytokines commonly associated with chronic neuropathic pain conditions (BDNF, Substance P, NGF, MCP-1, VEGF, IFN-gamma, IL-1, IL-6, TNF a), assessed by flow cytometry, single and multiplex ELISAs and mass spectrometry before and after treatment with amitriptyline (study 1) and spinal cord stimulation (study 2)<br> 2. Pain, measured using visual analogue pain scores and DN4 neuropathic pain questionnaires, and analgesic consumption before and after treatment with amitriptyline (study 1) and spinal cord stimulation (study 2)<br><br> The exact date after recruitment will be after at least 2 weeks for reflection. With study 1 the second sample will be taken 6-8 weeks after treatment with amitriptyline. In study 2 the second sample will be taken after 2 weeks of neuromodulation.<br>