Evidence map›Paper›PMID 34791634›Full record

ArticlePain and therapy2022

Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales.

Edgar Ross, Nathaniel P Katz, Philip G Conaghan, Alan Kivitz, Dennis C Turk, Andrew I Spitzer, Deryk G Jones, Ryan K Lanier, Amy Cinar, Joelle Lufkin and 1 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pain and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02357459 (A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 32% 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.

NCT02357459 phase3completednot on this map

A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

TypeinterventionalSponsorPacira Pharmaceuticals, IncRan2015 to 2016Enrolled486ConditionsOsteoarthritis of the KneeArmsFX006, Placebo, TCA IR 40
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Knee osteoarthritis: disease burden, available treatments, and emerging options.Therapeutic advances in musculoskeletal disease · 2024
    Review
  7. 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

11 authors at 8 institutions in 2 countries.

Edgar RossBrigham and Women's Hospital and Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA. elross@bwh.harvard.edu.
Nathaniel P KatzAnalgesic Solutions, 321 Commonwealth Rd, Wayland, MA, 01778, USA.
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, LS7 4SA, UK.
Alan KivitzAltoona Center for Clinical Research, 178 Meadowbrook Lane, P.O. Box 1018, Duncansville, PA, 16635, USA.
Dennis C TurkWashington Medicine, Box 356540, 1949 NE Pacific Street, Seattle, WA, 98195, USA.
Andrew I SpitzerDepartment of Orthopaedic Surgery, Cedars-Sinai Medical Center, 444 S. San Vicente Blvd #603, Los Angeles, CA, 90048, USA.
Deryk G JonesOchsner Sports Medicine Institute, 1221 S. Clearview Pkwy, Harahan, LA, 70121, USA.
Ryan K LanierAnalgesic Solutions, 321 Commonwealth Rd, Wayland, MA, 01778, USA.
Amy CinarFlexion Therapeutics Inc., 10 Mall Road, Suite 301, Burlington, MA, 01803, USA.
Joelle LufkinFlexion Therapeutics Inc., 10 Mall Road, Suite 301, Burlington, MA, 01803, USA.
Scott D KelleyFlexion Therapeutics Inc., 10 Mall Road, Suite 301, Burlington, MA, 01803, USA.
Flexion Therapeutics (United States) · USClinical Solutions · USAltoona Center for Clinical Research · USBrigham and Women's Hospital · USCedars-Sinai Medical Center · USMinnesota Orthopedic Sports Medicine Institute · USSeattle Reproductive Medicine · USUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA phase 3 randomized controlled study comparing triamcinolone acetonide extended-release (TA-ER) to conventional TA crystalline suspension (TAcs) reported variable efficacy results. Enrollment criteria may have contributed to this discrepancy, as moderate-to-severe average daily pain (ADP) was required at baseline, whereas no limitations were placed on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) pain severity. We conducted a post hoc sensitivity analysis to compare treatment effects in patients reporting moderate-to-severe osteoarthritis (OA) pain on both scales.

methodsParticipants > 40 years old with symptomatic knee OA were randomly assigned to a single intra-articular injection of TA-ER 32 mg, TAcs 40 mg, or saline-placebo and followed for 24 weeks. Patient-reported ADP, WOMAC-A, rescue medication usage, and adverse events (AEs) were assessed. Participants who reported moderate-to-severe OA pain at baseline using both instruments (ADP ≥ 5 to ≤ 9, maximum 10 and WOMAC-A ≥ 2, maximum 4) were categorized as "concordant" pain reporters; patients with baseline moderate-to-severe OA on ADP only were termed "discordant" pain reporters.

resultsTwo-hundred-ninety-two concordant pain reporters of 484 total subjects received TA-ER 32 mg (n = 95), TAcs 40 mg (n = 100), or saline-placebo (n = 97). Baseline characteristics and AE profiles of the concordant and discordant pain responders were consistent with the full analysis population. Among concordant pain reporters, TA-ER significantly (p < 0.05) improved ADP scores vs. TAcs (weeks 5-19; area-under-the-effect [AUE]

conclusionsIn patients reporting moderate-to-severe knee OA pain at baseline based on concordant ADP and WOMAC-A scores, TA-ER provided statistically significant pain relief for ≥ 12 weeks compared with conventional TAcs.

trial registrationClinicalTrials.gov Identifier: NCT02357459.

Indexed as

CorticosteroidIntra-articularKnee osteoarthritisPainTriamcinolone acetonide extended-release

Identifiers

PMID34791634
PMCPMC8861226
OpenAlexW3213871993

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.