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OpenTrials
Completed

NCT Number: NCT02180880

Symptom Based Treatment of Neuropathic Pain

1. Neuropathic pain in spinal cord injured patients

1. Inclusion criteria

* pain intensity, visual analogue scale > 3 * a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above * aged ≥20 2. Method

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

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Key information

Conditions

Neuralgia Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHA University

Seongnam-si, Kyounggi-do, 463-712, South Korea

About this study

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.

  • Pain intensity (VAS score)
  • 4 spontaneous characters
  • electric
  • burning
  • pricking
  • numbness
  • evoked pain
  • allodynia
  • heat hyperalgesia
  • pressure hyperalgesia
  • Location of neuropathic pain
  • neuropathic pain at level of spinal cord injury
  • neuropathic pain below level of spinal cord injury
  • Side effects

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin and Oxcarbazepine

Drug

Subjects will take pregabalin for the duration of 2 weeks. The dosage will be increased from 75 mg twice to 150 mg twice a day.

Subjects will stop pregabalin for 1 week and take oxcarbazepine 150mg twice.

Other names: Lyrica and Oxcarb

Primary outcomes

  1. Symptom based treatment of neuropathic pain

    Time frame: 2 week later

    Pain intensity using Visual analogue scale (0~100)

Sponsors and collaborators

Lead sponsor

Ju Seok Ryu

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 3, 2014
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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