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

Characterisation of the peptide and cellular constituents of cerebrospinal fluid implicated in the chronicity of neuropathic pain in vivo and its response to treatment with amitriptyline and neuromodulation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70120536

Enrollment

Registered

2017-09-12

Start date

2017-04-01

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lumbar radicular pain, failed back surgery syndrome, complex regional pain syndrome Signs and Symptoms

Interventions

Study 1: Amitriptyline study This is an interventional observational pilot study to determine the effects of amitriptyline on neuropeptides, lymphocytes and non-lymphocyte constituents

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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). 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.	—

Measure

Time frame

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). 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.

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Secondary

Measure	Time frame
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) 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) 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.	—

Measure

Time frame

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) 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) 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.

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Countries

Ireland

Contacts

Public ContactJonathan Royds

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026