Evidence map›Paper›PMID 16086839›Full record

Trial reportBMC musculoskeletal disorders2005

Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886].

Philip A Baer, Lisa M Thomas, Zev Shainhouse

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
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 2 registered trials, which are not on this map. Cited by 35 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 11 pooled it
3.2field-weighted citation impact, top 10% 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.

NCT01350622 nawithdrawnnot on this mapstarted 2011, after this paper: background citation

Efficacy of PENNSAID® for Pain Management in the Emergency Department

TypeinterventionalSponsorUniversity of UtahRan2011 to 2012Enrolled0ConditionsPain, Ankle SprainArmsPENNSAID, Diclofenac hydroxyethylpyrrolidine
NCT04412837 phase2withdrawnnot on this mapstarted 2022, after this paper: background citation

The Use of Cannabinoid Patch for Knee Osteoarthritis

TypeinterventionalSponsorNorthwell HealthRan2022 to 2024Enrolled0ConditionsKnee Osteoarthritis, CBD, OsteoarthritisArmsTopical CBD Patch, Placebo Patch
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 11 syntheses or guidelines pooled it, 103 citations in OpenAlex.

  1. Pooled it
  2. Drug-related Halitosis: A Systematic Review.Oral health & preventive dentistry · 2020
    Pooled it
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  8. Topical NSAIDs for chronic musculoskeletal pain in adults.The Cochrane database of systematic reviews · 2016
    Pooled it
  9. Topical NSAIDs for chronic musculoskeletal pain in adults.The Cochrane database of systematic reviews · 2012
    Pooled it
  10. Pooled it
  11. Osteoarthritis of the knee.BMJ clinical evidence · 2007
    Pooled it
  12. Trial
  13. Review
  14. Article
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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 2 institutions in 2 countries.

Philip A BaerMalvern Medical Centre, Toronto, Canada. philipbaer@rogers.com
Lisa M Thomas
Zev Shainhouse
Nuvo Pharmaceuticals (Canada) · CARogers (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTopical NSAIDs have been proven to relieve the symptoms of osteoarthritis (OA) in short-term studies (2 weeks). To justify its chronic use, efficacy of a topical NSAID over a longer term of study should be demonstrated. The efficacy and safety of a topical diclofenac solution over a 6-week treatment course in symptomatic primary OA of the knee was investigated.

methods216 men and women, age 40-85 years, with radiologically confirmed primary OA of the knee and a flare of pain at baseline following discontinuation of prior therapy were enrolled into this double-blind study. Participants applied either a topical diclofenac solution (Pennsaid) or vehicle control solution (carrier with no diclofenac); 40 drops 4 times daily directly to the painful knee(s), without massage, for 6 weeks. Pre-planned primary efficacy outcome measures included the core continuous variables pain relief and improved physical function measured by the Western Ontario and McMaster Universities (WOMAC) LK3.1 OA Index, and improved patient global assessment (PGA). Secondary efficacy measure was reduced stiffness. Safety assessments included adverse events and vital signs.

resultsThe topical diclofenac group had a significantly greater mean change in score (final minus baseline) compared to the vehicle control group for pain (-5.2 vs. -3.3, p = 0.003), physical function (-13.4 vs. -6.9, p = 0.001), PGA (-1.3 vs. -0.7, p = 0.0001) and stiffness (-1.8 vs. -0.9, p = 0.002). The mean difference between treatment arms (95% confidence interval [CI]) was 1.9 (0.7 to 3.2), 6.5 (2.5 to 10.5), 0.6 (0.2 to 0.9), and 0.9 (0.3 to 1.4), respectively. Safety analyses showed that topical diclofenac caused skin irritation, mostly minor local skin dryness, in 42/107 (39%), leading to discontinuation of treatment in 5/107 (5%) participants.

conclusionThis topical diclofenac solution demonstrated relief at 6 weeks of the symptoms of primary osteoarthritis of the knee.

Indexed as

Administration, TopicalAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalDiclofenacDrug Administration ScheduleFemaleHumansMaleMiddle AgedOsteoarthritis, KneePainSkin DiseasesSolutionsTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalDiclofenacSolutions

Identifiers

PMID16086839
PMCPMC1201146
OpenAlexW1890512155

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.