Symptom Based Treatment of Neuropathic Pain

August 18, 2014 updated by: Ju Seok Ryu

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

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kyounggi-do
      • Seongnam-si, Kyounggi-do, Korea, Republic of, 463-712
        • CHA University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin and Oxcarbazpepine
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.

Other Names:
  • Lyrica and Oxcarb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom based treatment of neuropathic pain
Time Frame: 2 week later
Pain intensity using Visual analogue scale (0~100)
2 week later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Ju Seok Ryu, MD, CHA University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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