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Symptom Based Treatment of Neuropathic Pain

Primary Purpose

Neuralgia, Spinal Cord Injury

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pregabalin and Oxcarbazepine
Sponsored by
Ju Seok Ryu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia focused on measuring Neuralgia, Spinal cord, Oxcarbazepine, Pregabalin, Drug therapy, Algorithms

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHA University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregabalin and Oxcarbazpepine

Arm Description

Pregabalin and Oxcarbazepine

Outcomes

Primary Outcome Measures

Symptom based treatment of neuropathic pain
Pain intensity using Visual analogue scale (0~100)

Secondary Outcome Measures

Full Information

First Posted
June 5, 2014
Last Updated
August 18, 2014
Sponsor
Ju Seok Ryu
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1. Study Identification

Unique Protocol Identification Number
NCT02180880
Brief Title
Symptom Based Treatment of Neuropathic Pain
Official Title
Symptom-Based Treatment for Neuropathic Pain in Spinal Cord Injured Patients, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ju Seok Ryu

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
1. Neuropathic pain in spinal cord injured patients Inclusion criteria pain intensity, visual analogue scale > 3 a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above aged ≥20 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. 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 2. Side effects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Spinal Cord Injury
Keywords
Neuralgia, Spinal cord, Oxcarbazepine, Pregabalin, Drug therapy, Algorithms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin and Oxcarbazpepine
Arm Type
Experimental
Arm Description
Pregabalin and Oxcarbazepine
Intervention Type
Drug
Intervention Name(s)
Pregabalin and Oxcarbazepine
Other Intervention Name(s)
Lyrica and Oxcarb
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom based treatment of neuropathic pain
Description
Pain intensity using Visual analogue scale (0~100)
Time Frame
2 week later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ju Seok Ryu, MD
Organizational Affiliation
CHA University
Official's Role
Study Chair
Facility Information:
Facility Name
CHA University
City
Seongnam-si
State/Province
Kyounggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26368836
Citation
Min K, Oh Y, Lee SH, Ryu JS. Symptom-Based Treatment of Neuropathic Pain in Spinal Cord-Injured Patients: A Randomized Crossover Clinical Trial. Am J Phys Med Rehabil. 2016 May;95(5):330-8. doi: 10.1097/PHM.0000000000000382.
Results Reference
derived

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Symptom Based Treatment of Neuropathic Pain

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