A capsaicin (8%) patch in the treatment of severe persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled trial
Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options. This randomized placebo-controlled trial investigated the efficacy of a capsaicin 8% cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy...
Saved in:
Published in | PloS one Vol. 9; no. 10; p. e109144 |
---|---|
Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Public Library of Science
07.10.2014
Public Library of Science (PLoS) |
Subjects | |
Online Access | Get full text |
Cover
Loading…
Summary: | Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options. This randomized placebo-controlled trial investigated the efficacy of a capsaicin 8% cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy pain.
Forty-six patients with persistent inguinal postherniorrhaphy pain were randomized to receive either a capsaicin 8% patch or a placebo patch. Pain intensity (Numerical Rating Scale [NRS 0-10]) was evaluated under standardized conditions (at rest, during movement, and during pressure) at baseline and at 1, 2 and 3 months after patch application. Skin punch biopsies for intraepidermal nerve fiber density (IENFD) measurements were taken at baseline and 1 month after patch application. Quantitative sensory testing was performed at baseline and at 1, 2, and 3 months after patch application. The primary outcome was comparisons of summed pain intensity differences (SPIDs) between capsaicin and placebo treatments at 1, 2 and 3 months after patch application (significance level P < 0.01).
The maximum difference in SPID, between capsaicin and placebo treatments, was observed at 1 month after patch application, but the pain reduction was not significant (NRS, mean difference [95% CI]: 5.0 [0.09 to 9.9]; P = 0.046). No differences in SPID between treatments were observed at 2 and 3 months after patch application. Changes in IENFD on the pain side, from baseline to 1 month after patch application, did not differ between capsaicin and placebo treatment: 1.9 [-0.1 to 3.9] and 0.6 [-1.2 to 2.5] fibers/mm, respectively (P = 0.32). No significant changes in sensory function, sleep quality or psychological factors were associated with capsaicin patch treatment.
The study did not demonstrate significant differences in pain relief between capsaicin and placebo treatment, although a trend toward pain improvement in capsaicin treated patients was observed 1 month after patch application.
Clinicaltrialsregister.eu 2012-001540-22 ClinicalTrials.gov NCT01699854. |
---|---|
Bibliography: | Competing Interests: The authors have read the journal's policy and have the following conflicts: JMB and MW have received an unrestricted research grant from Grünenthal GmbH, Aachen, Germany. CS and NÜ have been speakers for Astellas GmbH, Germany and NÜ has received travel grants from Astellas GmbH, Germany. CS and NÜ are PLOS ONE Editorial Board members. The study was supported by an unrestricted research grant from Astellas Pharma a/s, Kastrup, Denmark. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials. Wrote the paper: JMB MW. Critically revising the manuscript: TR MP CS NÜ. Conceived and designed the experiments: JMB MW CS NÜ. Performed the experiments: JMB TR MP. Analyzed the data: JMB MW. Contributed reagents/materials/analysis tools: MW CS NÜ. |
ISSN: | 1932-6203 1932-6203 |
DOI: | 10.1371/journal.pone.0109144 |