Clinical trial NCT03618589: Pregabalin add-on for Neuropathic Pain in Cervical Myelopathy
Official title: Comparison of Effectiveness of Opioid Only and Pregabalin add-on for the Treatment of Neuropathic Pain in Cervical Myelopathy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pain, Neuropathic
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Leeds assessment of neuropathic symptoms and signs (LANSS) and visual analogue scale (VAS)
timeFrame: 2 months
Secondary outcomes:
measure: neck disability index (NDI) and EuroQol- 5 Dimension (EQ-5D)
timeFrame: 2 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chun Kee Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: