Pregabalin add-on for Neuropathic Pain in Cervical Myelopathy

NCT ID: NCT03618589

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-26
• Study Completion Date: 2019-12-31

Brief Summary

There is no information on the effect of pregabalin in patients with neuropathic pain in cervical myelopathy under routine clinical practice.

The investigators will conduct this prospective, randomized trial to determine the efficacy of pregabalin for neuropathic pain in cervical myelopathic patients in order to validate or refute this popular practice. The primary aim of this study was to compare Leeds assessment of neuropathic symptoms and signs scale (LANSS) scores of neuropathic pain in cervical myelopathy patients.

Detailed Description

Neuropathic pain is a well-recognized clinical entity. It is defined as pain caused by the lesion or dysfunction of the peripheral or central nervous system, and it can be diagnosed by well-established clinical criteria. Neuropathic pain is caused by lesions or dysfunction of the nervous system and is initiated by several cellular and molecular mechanisms. Compression of neural and neurovascular structures may result in neuropathic pain. Although a number of therapies are available for neuropathic pain, including antidepressants, tramadol, opioids, and different antiepileptic drugs, the results of a recent systematic review suggest that, in view of their balance between efficacy and tolerability, pregabalin can be regarded as first line treatments for peripheral pain with a neuropathic component.

Pregabalin is one of antiepileptic drugs (AEDs) that have been studied in the treatment of a wide variety of disorders, such as neuropathic pain, epilepsy, spasticity, and anxiety. The use of AEDs in the treatment of neuropathic pain is based on a number of similarities in the pathophysiologic and biochemical mechanisms underlying neuropathic pain and epilepsy. Its use for the treatment of several neuropathic pain syndromes is common, and it is approved by the Food and Drug Administration (FDA) for the treatment of diabetic neuropathy, post-herpetic neuralgia, fibromyalgia and spinal cord injury, a model of central neuropathic pain. The off-label use of pregabalin for the various pain syndromes in general, and for neuropathic pain in particular, is ubiquitous. However, minimal support for this practice exists in the literature and its cost is perhaps exorbitant. There is no information on the effect of pregabalin in patients with neuropathic pain in cervical myelopathy under routine clinical practice.

Conditions

Pain, Neuropathic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

opioid only

Patients in the opioid group received the only opioid (5mg of oxycodone three times a day) for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Opioid

Intervention Type: DRUG

Patients in the opioid group received the only opioid (5mg of oxycodone three times a day) for 8 weeks.

pregabalin add-on

Patients in the pregabalin add-on group received 75mg of pregabalin twice a day for the first week (150 mg/day) and 150mg of pregabalin twice a day (300 mg/day) for the second week and 300mg of pregabalin twice a day (600mg/day) for subsequent 6 weeks.

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: DRUG

Patients in the pregabalin add-on group received 75mg of pregabalin twice a day for the first week (150 mg/day) and 150mg of pregabalin twice a day (300 mg/day) for the second week and 300mg of pregabalin twice a day (600mg/day) for subsequent 6 weeks.

Opioid

Intervention Type: DRUG

Patients in the opioid group received the only opioid (5mg of oxycodone three times a day) for 8 weeks.

Interventions

Pregabalin

Patients in the pregabalin add-on group received 75mg of pregabalin twice a day for the first week (150 mg/day) and 150mg of pregabalin twice a day (300 mg/day) for the second week and 300mg of pregabalin twice a day (600mg/day) for subsequent 6 weeks.

Intervention Type: DRUG

Opioid

Patients in the opioid group received the only opioid (5mg of oxycodone three times a day) for 8 weeks.

Intervention Type: DRUG

Other Intervention Names

Lyrica; IRcordon

Eligibility Criteria

Inclusion Criteria

1. between the ages of 18 to 80 years

2. Among patients with cervical myelopathy, patients with neuropathic pain (LANSS pain scale ≥ 12)

3. Completing 8-week drug trial

Exclusion Criteria

1. Current or prior gabapentin or pregabalin use

2. Chronic use of narcotic pain medications

3. Chronic depression or the use of anti-depressants

4. History of addiction and/or substance abuse

5. Presence of significant motor deficits, and /or bowel and/or bladder dysfunction

6. Known renal insufciency, diabetes, congestive heart failure, cardiac conduction abnormalities, and thrombocytopenia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chun Kee Chung

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chun Kee Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Chun Kee Chung, MD, PhD

Role: CONTACT

chungc@snu.ac.kr

+82-2-2072-2352

Jong-myung Jung, MD

Role: CONTACT

beast2625@naver.com

+82-2-2072-2358

Facility Contacts

Jong-myung Jung, MD

Role: primary

beast2625@naver.com

+82-2-2072-2358

Other Identifiers

pregabalin & LANSS

Identifier Type: -

Identifier Source: org_study_id