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The purpose of this observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.
This study is a prospective, open-label, non-interventional study. The objective of the study is to investigate the impact of fentanyl matrix on improvement of pain and functioning after 8-week treatment of fentanyl matrix in the patients who complained of spinal disorder-related chronic pain in clinical practice according to the investigator's discretion. The primary endpoint is a percent of pain intensity difference between baseline and week 8 of the study. Each patients will evaluate their pain intensity every 28 days during the 8 weeks. The secondary objectives are to observe the change in the following variables after administrating fentanyl matrix; K-ODI (Korean version - Oswestry Disability Index) score, sleep disturbance, disturbance of activities of daily living and disturbance of social activities. In addition, Investigator and patient global assessment, patient preference, CGI-I (Clinical Global Impression - Improvement) and Adverse Events will be investigated. LDK: Lumbar degenerative kyphosis, CRPS: Complex Regional Pain SYndrome, FBSS: Failed Back Surgery Syndrome Observational Study - No investigational drug administered
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 |
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| 002 |
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| 003 |
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| 004 |
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| 005 |
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| 006 |
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| 007 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fentanyl | Drug | Infection, starting with 12mcg/h (flexible dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity with Numeric Rating Scale | baseline, week 4 and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of activity of daily living and social activities | baseline, week 4 and week 8 | |
| Investigator and patient global assessment | baseline, week 4 and week 8 | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who had unsatisfactory treatment with previous medication (severe pain: NRS = 7) and no experience with fentanyl matrix will be eligible
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. | Study Director |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| fentanyl |
| Drug |
(CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose) |
|
| fentanyl | Drug | Bone Fracture, starting with 12mcg/h (flexible dose) |
|
| fentanyl | Drug | (FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose) |
|
| fentanyl | Drug | Other Deformity, starting with 12mcg/h (flexible dose) |
|
| fentanyl | Drug | (LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose) |
|
| fentanyl | Drug | Degenerative Spine Disorder, starting with 12mcg/h (flexible dose) |
|
| CGI-I (Clinical Global Impression) |
| baseline, week 4 and week 8 |
| K-ODI (Korean version of Oswestry Disability Index) | baseline, week 4 and week 8 |
| Improvement of sleep disturbance | baseline, week 4 and week 8 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |