Symptom Based Treatment of Neuropathic Pain

Phase 4

Completed

• Conditions: Neuralgia; Spinal Cord Injury
• Interventions: Drug: Pregabalin and Oxcarbazepine

• Registration Number: NCT02180880
• Lead Sponsor: Ju Seok Ryu

Brief Summary

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

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

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregabalin and Oxcarbazpepine	Pregabalin and Oxcarbazepine	Pregabalin and Oxcarbazepine

Primary Outcome Measures

Name	Time	Method
Symptom based treatment of neuropathic pain	2 week later	Pain intensity using Visual analogue scale (0\~100)

Trial Locations

Locations (1)

CHA University; 🇰🇷 Seongnam-si, Kyounggi-do, Korea, Republic of