Skip to main content
OpenTrials
Completed

NCT Number: NCT01061697

Pregabalin and Radicular Pain Study (PARPS)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Spondylosis Bone Diseases Cervical Spondylotic Myelopathy Cervical Spondylotic Radiculopathy Musculoskeletal Diseases Spinal Diseases Spondylosis

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Singapore General Hospital

Singapore, Outram Road, 169608

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

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

Other names: Brand name: Lyrica

Primary outcomes

  1. Visual Analogue Scale (VAS): Pain ruler done daily

    Time frame: 2 months

Secondary outcomes

  1. Short-Form McGill Pain Questionnaire (SFMPQ)

    Time frame: 0, 1, 2 months

  2. Patient and Clinical Global Impression of change

    Time frame: 0, 1, 2 months

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: PARPS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 3, 2010
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.