Pregabalin and Radicular Pain Study (PARPS)

Cervical Spondylosis Clinical Trial

— PARPS  

Official title:

Open Labelled Study of Pregabalin in the Treatment of Neuropathic Pain in Cervical Myeloradiculopathy (Pregabalin and Radicular Pain Study (PARPS))

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061697
• Other study ID #: #2006/072/A
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2010
• Last updated: July 4, 2011
• Start date: January 2008
• Est. completion date: April 2010

Study information

• Verified date: July 2011
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Spondylosis
• Cervical Spondylotic Myelopathy
• Cervical Spondylotic Radiculopathy
• Radiculopathy
• Spondylosis

Intervention

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 month

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore	Outram Road

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS): Pain ruler done daily		2 months	No
Secondary	Short-Form McGill Pain Questionnaire (SFMPQ)		0, 1, 2 months	No
Secondary	Patient and Clinical Global Impression of change		0, 1, 2 months	No