Neuropathic Pain, Spinal Stenosis
Conditions
Keywords
neuropathic pain, gabapentin, transdermal fentanyl matrix, multicenter, non-inferiority trial
Brief summary
Gabapentin is a first line medication and fentanyl is second line medication in neuropathic pain. But, there is no head to head study on the efficacy of those medication in neuropathic pain. The hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not inferior to the gabapentin in neuropathic pain.
Interventions
DRUGtransdermal fentanyl matrix, gabapentin
transdermal fentanyl matrix: during 1st to 6th days, 12ug/h of fentanyl matrix will be applied. During 7th to 28th days, the dosage of fentanyl matrix will be increased until the pain score decrease not more than 2 every 6 days. The maximal dosage is 100ug/h. During 29th to 56th days, the dosage will be maintained. Gabapentin: the 1st day, 300mg hs, the 2nd day, 300mg bid, the 3th to 4th days, 300mg tid, the 5th to 6th days, 300mg-300mg-600mg the 7th to 28 days, the dosage will be increased until the pain score decreased not more than 2 and the maximal dose is 2400mg per day. During 29th to 56th days, the dosage will be maintained.
Sponsors
Seoul National University Bundang Hospital
Asan Medical Center
Inje University
Chonnam National University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Dankook University
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients are 20 years of age or older * patients had chronic pain for more than 3 months and average pain score for last 3 days is not less than 4 (NRS) * neuropathic pain caused by the spinal stenosis (radiating pain, motor or sensory change * positive MRI finding or radiculopathy was confirmed by the EMG/NCS or not less than 12 points in the S-LANSS score assessment * patients who can make out the questionnaire * patients have agreed with the informed consent
Exclusion criteria
* patients who have experience with gabapentin, pregabalin, fentanyl matrix, long-acting strong opioid (CR oxycodone, SR morphine) * patients who have other causes of neuropathy such as hypothyroidism, Vit B12 deficiency, connective tissue disease, etc. * patients who have other disease which causes more pain compared with neuropathic pain * patients with a history of drug or alcohol abuse * patients who are pregnant or have the possibility of pregnancy * patients who are unable to use a transdermal system due to skin disease * patients with a serious mental disease * patients with a history of hypersensitivity to opioid analgesics * patients with a chronic pulmonary disease or respiratory depression * patients combined with industrial accidents or traffic accidents * at investigator's discretion, any condition where a subject cannot take part in the clinical study on the ground of warning, cautions, and prohibition in study investigator's brochure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group | Visit1 (Day 1), Visit 2 (Day 22-36), Vist3 (Day 50-64) | Post-treatment pain intensity scores will be used to determine the percentage of pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences of Oswestry Disability Index score, SF-36, BDI score, investigator and patients global assessment between gabapentin used group and transdermal fentanyl matrix used group | Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64) | Post-treatment secondary efficacy assessments will be used to determine the percentage of difference and secondary efficacy assessments included the following. 1. Korean Oswestry Disability Index score, Korean-Short-Form 36, Beck Depression Index score, investigator and patients global assessment. |
Countries
South Korea
Outcome results
None listed