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Pregabalin and Radicular Pain Study (PARPS)

S

Singapore Health Services (SingHealth)

Status and phase

Completed
Phase 4

Conditions

Cervical Spondylotic Myelopathy
Cervical Spondylosis
Cervical Spondylotic Radiculopathy

Treatments

Drug: Pregabalin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01061697
#2006/072/A

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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