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Clinical Trials/NCT02180880
NCT02180880
Completed
Phase 4

Symptom-Based Treatment for Neuropathic Pain in Spinal Cord Injured Patients, Randomized Clinical Trial

Ju Seok Ryu1 site in 1 country63 target enrollmentNovember 2012

Overview

Phase
Phase 4
Intervention
Pregabalin and Oxcarbazepine
Conditions
Neuralgia
Sponsor
Ju Seok Ryu
Enrollment
63
Locations
1
Primary Endpoint
Symptom based treatment of neuropathic pain
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

  1. Neuropathic pain in spinal cord injured patients

  2. Inclusion criteria

    • pain intensity, visual analogue scale > 3
    • a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
    • aged ≥20
  3. Method

    • Stop pain medications
    • Test oxcarbazepine (150mg twice daily) and pregabalin (150mg twice daily)
    • Check pain intensity (VAS score) with Baron's classification

Detailed Description

In the present study, pharmacologic treatment included pregabalin and oxcarbazepine. Stop medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), tramadol and anti-spastic drugs (baclofen, tizanidine) and other medications known to have effect on pain and the central nervous system prior to the study for at least 3 days. 1. Pain intensity (VAS score) 1. 4 spontaneous characters * electric * burning * pricking * numbness 2. evoked pain * allodynia * heat hyperalgesia * pressure hyperalgesia 2. Location of neuropathic pain 1. neuropathic pain at level of spinal cord injury 2. neuropathic pain below level of spinal cord injury 2. Side effects

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
August 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ju Seok Ryu
Responsible Party
Sponsor Investigator
Principal Investigator

Ju Seok Ryu

Assistant professor

CHA University

Eligibility Criteria

Inclusion Criteria

  • aged than 20 years
  • Neuropathic pain symptoms : LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
  • Visual analogue scale score of 3 and above

Exclusion Criteria

  • No pregnancy
  • systemic disease
  • psychiatric disease

Arms & Interventions

Pregabalin and Oxcarbazpepine

Pregabalin and Oxcarbazepine

Intervention: Pregabalin and Oxcarbazepine

Outcomes

Primary Outcomes

Symptom based treatment of neuropathic pain

Time Frame: 2 week later

Pain intensity using Visual analogue scale (0\~100)

Study Sites (1)

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