Cervical Spondylosis, Cervical Spondylotic Myelopathy, Cervical Spondylotic Radiculopathy
Conditions
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.
Interventions
DRUGPregabalin
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
Sponsors
Pfizer
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS): Pain ruler done daily | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Short-Form McGill Pain Questionnaire (SFMPQ) | 0, 1, 2 months |
| Patient and Clinical Global Impression of change | 0, 1, 2 months |
Countries
Singapore
Outcome results
None listed