Evidence map›Paper›PMID 15958159›Full record

Trial reportBMC musculoskeletal disorders2005

Transdermal fentanyl for the treatment of pain caused by osteoarthritis of the knee or hip: an open, multicentre study.

Xavier Le Loët, Karel Pavelka, Ute Richarz

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in BMC musculoskeletal disorders, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00524160 (Open-Label Study To Assess The Effect On Pain Control Of Durogesic), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00524160 phase4completednot on this map

Open-Label Study To Assess The Effect On Pain Control Of Durogesic (Fentanyl Transdermic Therapeutic System) Treatment In Subjects With Rheumatoid Arthritis Or Osteoarthritis Of The Knee Or Hip.

TypeinterventionalSponsorJanssen Pharmaceutica N.V., BelgiumRan2001 to 2002Enrolled264ConditionsArthritis, Osteoarthritis, Rheumatoid ArthritisArmsFentanyl transdermal patch
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Oral or transdermal opioids for osteoarthritis of the knee or hip.The Cochrane database of systematic reviews · 2014
    Pooled it
  2. Pooled it
  3. Trial
  4. Opioids in chronic musculoskeletal conditions.Therapeutic advances in musculoskeletal disease · 2010
    Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 3 institutions in 3 countries.

Xavier Le LoëtCentre Hospitalier Universitaire de Rouen, Hôpitaux Rouen, Rouen, France. Xavier.Le-Loet@chu-rouen.fr
Karel Pavelka
Ute Richarz
Institute of Rheumatology · CZJanssen (Switzerland) · CHUniversité de Rouen Normandie · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study was designed to evaluate the utility of transdermal fentanyl (TDF, Durogesic) for the treatment of pain due to osteoarthritis (OA) of the knee or hip, which was not adequately controlled by non-opioid analgesics or weak opioids. The second part of the trial, investigating TDF in patients with rheumatoid arthritis (RA) is reported separately.

methodsCurrent analgesia was optimised during a 1-week run-in. Patients then received 28 days treatment with TDF starting at 25 microg/hr, with the option to increase the dose until adequate pain control was achieved. Metoclopramide was taken during the first week and then as needed.

resultsOf the 159 patients recruited, 75 with OA knee and 44 with OA hip completed the treatment phase, 30 knee and 18 hip patients entered the one-week taper-off phase. The most frequently used maximum dose of TDF was 25 microg/hr. The number of patients with adequate pain control increased during the run-in period from 4% to 27%, and further increased during TDF treatment to 88% on day 28. From baseline to endpoint, there were significant reductions in pain (p < 0.001) and improvements in functioning (p < 0.001) and physical (p < 0.001) and mental (p < 0.05) health. Scores for 'pain right now' decreased significantly within 24 hours of starting TDF treatment. TDF was assessed favourably and 84% of patients would recommend it for OA-related pain. Nausea and vomiting were the most common adverse events (reported by 32% and 26% of patients respectively), despite prophylaxis with metoclopramide, which showed limited efficacy in this setting.

conclusionTDF significantly increased pain control, and improved functioning and quality of life. Metoclopramide appeared to be of limited value in preventing nausea and vomiting; more effective anti-emetic treatment may enable more people to benefit from strong opioids such as TDF. This study suggests that four weeks is a reasonable period to test the benefit of adding TDF to improve pain control in OA patients and that discontinuing therapy in cases of limited benefit creates no major obstacles.

Indexed as

Administration, CutaneousAnalgesics, OpioidDose-Response Relationship, DrugFentanylHumansMiddle AgedOsteoarthritis, HipOsteoarthritis, KneePainPatient DropoutsQuality of LifeSurveys and QuestionnairesTreatment OutcomeAnalgesics, OpioidFentanyl

Identifiers

PMID15958159
PMCPMC1181817
OpenAlexW1512547215

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.