Evidence map›Paper›PMID 38692727›Full record

Trial reportBMJ open2024

Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial.

Sally Hopewell, Cynthia Srikesavan, Alison Evans, Fema Er, Amar Rangan, Jane Preece, Anne Francis, M Sofia Massa, Marc Feldmann, Sarah Lamb and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05299242 (Anti-TNF), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.3field-weighted citation impact, top 13% 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.

NCT05299242 phase2 / phase3completednot on this map

Anti-TNF (Adalimumab) Injection for the Treatment of Adults With Frozen Shoulder During the Pain-predominant Phase: a Multi-centre, Randomised, Double Blind, Parallel Group, Feasibility Study

TypeinterventionalSponsorUniversity of OxfordRan2022 to 2023Enrolled9ConditionsFrozen ShoulderArmsAdalimumab Injection, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
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 4 institutions in 1 country.

Sally HopewellOxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK sally.hopewell@csm.ox.ac.uk.ORCID 0000-0002-6881-6984
Cynthia SrikesavanCentre for Rehabilitation Research in Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Alison EvansKennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Fema ErOxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Amar RanganSouth Tees Hospitals NHS Foundation Trust, The James Cook University Hospital, Middlesbrough, UK.ORCID 0000-0002-5452-8578
Jane PreecePatient and Public Involvement Representative, Kidderminster, UK.
Anne FrancisOxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
M Sofia MassaOxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0003-3205-6706
Marc FeldmannKennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Sarah LambCollege of Medicine and Health, University of Exeter, Exeter, UK.
Jagdeep NanchahalKennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Nuffield Orthopaedic Centre · GBUniversity of Exeter · GBJames Cook University Hospital · GBKidderminster Hospital and Treatment Centre · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder.

designMulticentre, randomised feasibility trial, with embedded qualitative study.

settingFour UK National Health Service (NHS) musculoskeletal and related physiotherapy services.

participantsAdults ≥18 years with new episode of shoulder pain attributable to early-stage frozen shoulder.

interventionsParticipants were randomised (centralised computer generated 1:1 allocation) to either ultrasound-guided intra-articular injection of: (1) adalimumab (160 mg) or (2) placebo (saline (0.9% sodium chloride)). Participants and outcome assessors were blinded to treatment allocation. Second injection of allocated treatment (adalimumab 80 mg) or equivalent placebo was administered 2-3 weeks later. PRIMARY FEASIBILITY

objectives(1) Ability to screen and identify participants; (2) willingness of eligible participants to consent and be randomised; (3) practicalities of delivering the intervention; (4) SD of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months.

resultsBetween 31 May 2022 and 7 February 2023, 156 patients were screened of whom 39 (25%) were eligible. The main reasons for ineligibility were other shoulder disorder (38.5%; n=45/117) or no longer in pain-predominant frozen shoulder (33.3%; n=39/117). Of the 39 eligible patients, nine (23.1%) consented to be randomised (adalimumab n=4; placebo n=5). The main reason patients declined was because they preferred receiving steroid injection (n=13). All participants received treatment as allocated. The mean time from randomisation to first injection was 12.3 (adalimumab) and 7.2 days (placebo). Completion rates for patient-reported and clinician-assessed outcomes were 100%.

conclusionThis study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment. TRIAL REGISTRATION NUMBER: ISRCTN 27075727, EudraCT 2021-03509-23, ClinicalTrials.gov NCT05299242 (REC 21/NE/0214).

Indexed as

AdalimumabBursitisFeasibility StudiesShoulder PainAdultAgedFemaleHumansInjections, Intra-ArticularMaleMiddle AgedPain MeasurementTreatment OutcomeUltrasonography, InterventionalUnited KingdomAdalimumabMusculoskeletal disordersPatientsShoulder

Identifiers

PMID38692727
PMCPMC11086567
OpenAlexW4396561924

What OpenQuestion holds

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LicenceCC BY
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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.