Symptom Based Treatment of Neuropathic Pain

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180880
• Other study ID #: NeuropathicPain
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2014
• Last updated: August 18, 2014
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Pregabalin and Oxcarbazepine
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.

Locations

Country	Name	City	State
Korea, Republic of	CHA University	Seongnam-si	Kyounggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ju Seok Ryu

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom based treatment of neuropathic pain	Pain intensity using Visual analogue scale (0~100)	2 week later	Yes