Back to resultsPregabalin and Radicular Pain Study (PARPS) (PARPS)
Primary Purpose
Cervical Spondylosis, Cervical Spondylotic Myelopathy, Cervical Spondylotic Radiculopathy
Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spondylosis
Eligibility Criteria
Inclusion Criteria:
- Clinical & MRI, or electrophysiological evidence of pain due to radiculopathy
- Patients with CS and CSR or CSM with neuropathic pain due to the above in the neck and upper limbs or lower limbs (including dysesthesia, paresthesia, hyperalgesia).
Exclusion Criteria:
- Diabetic neuropathy or other underlying neuropathic conditions
- Contraindications and allergy to pregabalin
- Previously treated with gabapentin in the last 8 weeks
- Pregnant or breast feeding
- History of renal impairment
- History of other causes of neuropathic pain
Sites / Locations
- Singapore General Hospital
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS): Pain ruler done daily
Secondary Outcome Measures
Short-Form McGill Pain Questionnaire (SFMPQ)
Patient and Clinical Global Impression of change
Full Information
NCT ID
NCT01061697
First Posted
February 2, 2010
Last Updated
July 4, 2011
Sponsor
Singapore General Hospital
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01061697
Brief Title
Pregabalin and Radicular Pain Study (PARPS)
Acronym
PARPS
Official Title
Open Labelled Study of Pregabalin in the Treatment of Neuropathic Pain in Cervical Myeloradiculopathy (Pregabalin and Radicular Pain Study (PARPS))
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Singapore General Hospital
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to investigate the effectiveness of pregabalin (Lyrica) on nerve pain caused by degenerative neck problems. Pregabalin is a new drug registered for use in nerve pain worldwide
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis, Cervical Spondylotic Myelopathy, Cervical Spondylotic Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Brand name: Lyrica
Intervention Description
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 month
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS): Pain ruler done daily
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Short-Form McGill Pain Questionnaire (SFMPQ)
Time Frame
0, 1, 2 months
Title
Patient and Clinical Global Impression of change
Time Frame
0, 1, 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical & MRI, or electrophysiological evidence of pain due to radiculopathy
Patients with CS and CSR or CSM with neuropathic pain due to the above in the neck and upper limbs or lower limbs (including dysesthesia, paresthesia, hyperalgesia).
Exclusion Criteria:
Diabetic neuropathy or other underlying neuropathic conditions
Contraindications and allergy to pregabalin
Previously treated with gabapentin in the last 8 weeks
Pregnant or breast feeding
History of renal impairment
History of other causes of neuropathic pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Y L Lo, MD
Organizational Affiliation
National Neuroscience Institute, Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
State/Province
Outram Road
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
Pregabalin and Radicular Pain Study (PARPS)
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