Pregabalin and Radicular Pain Study (PARPS)
Cervical Spondylotic Myelopathy
Cervical Spondylotic Radiculopathy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Labelled Study of Pregabalin in the Treatment of Neuropathic Pain in Cervical Myeloradiculopathy (Pregabalin and Radicular Pain Study (PARPS))|
- Visual Analogue Scale (VAS): Pain ruler done daily [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Short-Form McGill Pain Questionnaire (SFMPQ) [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
- Patient and Clinical Global Impression of change [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061697
|Singapore General Hospital|
|Singapore, Outram Road, Singapore, 169608|
|Principal Investigator:||Y L Lo, MD||National Neuroscience Institute, Singapore General Hospital|