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Pregabalin and Radicular Pain Study (PARPS) (PARPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01061697
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : July 6, 2011
Information provided by:
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

Condition or disease Intervention/treatment Phase
Cervical Spondylosis Cervical Spondylotic Myelopathy Cervical Spondylotic Radiculopathy Drug: Pregabalin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Labelled Study of Pregabalin in the Treatment of Neuropathic Pain in Cervical Myeloradiculopathy (Pregabalin and Radicular Pain Study (PARPS))
Study Start Date : January 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Intervention Details:
  • 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
    Other Name: Brand name: Lyrica

Primary Outcome Measures :
  1. Visual Analogue Scale (VAS): Pain ruler done daily [ Time Frame: 2 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01061697

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Singapore General Hospital
Singapore, Outram Road, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
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Principal Investigator: Y L Lo, MD National Neuroscience Institute, Singapore General Hospital
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Responsible Party: A/Prof Lo Yew Long, National Neuroscience Institute, Singapore General Hospital Identifier: NCT01061697    
Other Study ID Numbers: #2006/072/A
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Spinal Cord Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Central Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs