Pregabalin and Radicular Pain Study (PARPS)

Phase 4

Completed

• Conditions: Cervical Spondylosis; Cervical Spondylotic Myelopathy; Cervical Spondylotic Radiculopathy

• Registration Number: NCT01061697
• Lead Sponsor: Singapore General Hospital

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-04
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS): Pain ruler done daily	2 months

Secondary Outcome Measures

Name	Time	Method
Short-Form McGill Pain Questionnaire (SFMPQ)	0, 1, 2 months
Patient and Clinical Global Impression of change	0, 1, 2 months

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Outram Road, Singapore