Pregabalin and Radicular Pain Study (PARPS) (PARPS)
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|ClinicalTrials.gov Identifier: NCT01061697|
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : July 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cervical Spondylosis Cervical Spondylotic Myelopathy Cervical Spondylotic Radiculopathy||Drug: Pregabalin||Phase 4|
The treatment of neuropathic pain is clinically challenging, and pain from cervical spondylosis (CS) is a common variant. This may result from degenerative spinal canal/cord stenosis (cervical spondylotic myelopathy (CSM)) or lateral recesses compromise, leading to nerve root compression (cervical spondylotic radiculopathy (CSR)).
Pregabalin is a newly registered drug for the treatment of neuropathic pain. Its efficacy has been proven in randomised, placebo-controlled trials for post-herpetic neuralgia and diabetic neuropathy. However, its efficacy in CS with underlying CSR or CSM has not been established. Additionally, there are no data to date on its use in Asian patients.
In this study, we prospectively evaluate its efficacy for treating neuropathic pain in degenerative CSR/ CSM 60 patients in an open-labelled, add on fashion. Self-evaluation and investigator rated scoring will be implemented.
The results will be of value in the non-operative management of CS.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Labelled Study of Pregabalin in the Treatment of Neuropathic Pain in Cervical Myeloradiculopathy (Pregabalin and Radicular Pain Study (PARPS))|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||April 2010|
- Drug: Pregabalin
At week 0, pregabalin 75mgbd will be given for 1 month. If visual analogue scale is not reduced by 50% after 1 month, pregabalin will be increased to 150mgbd for the second monthOther Name: Brand name: Lyrica
- Visual Analogue Scale (VAS): Pain ruler done daily [ Time Frame: 2 months ]
- Short-Form McGill Pain Questionnaire (SFMPQ) [ Time Frame: 0, 1, 2 months ]
- Patient and Clinical Global Impression of change [ Time Frame: 0, 1, 2 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061697
|Singapore General Hospital|
|Singapore, Outram Road, Singapore, 169608|
|Principal Investigator:||Y L Lo, MD||National Neuroscience Institute, Singapore General Hospital|