Symptom Based Treatment of Neuropathic Pain

NCT ID: NCT02180880

Last Updated: 2014-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-08-31

Brief Summary

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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

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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

Conditions

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Neuralgia Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pregabalin and Oxcarbazpepine

Pregabalin and Oxcarbazepine

Group Type EXPERIMENTAL

Pregabalin and Oxcarbazepine

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lyrica and Oxcarb

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ju Seok Ryu

OTHER

Sponsor Role lead

Responsible Party

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Ju Seok Ryu

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ju Seok Ryu, MD

Role: STUDY_CHAIR

CHA University

Locations

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CHA University

Seongnam-si, Kyounggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 26368836 (View on PubMed)

Other Identifiers

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NeuropathicPain

Identifier Type: -

Identifier Source: org_study_id

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