Evidence map›Paper›PMID 31640992›Full record

ArticleBMJ open2019

The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis.

Jo Adams, Paula Barratt, Nigel K Arden, Sofia Barbosa Bouças, Sarah Bradley, Michael Doherty, Susan Dutton, Krysia Dziedzic, Rachael Gooberman-Hill, Kelly Hislop Lennie and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. 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

16 authors at 10 institutions in 1 country.

Jo AdamsSchool of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK ja@soton.ac.uk.ORCID 0000-0003-1765-7060
Paula BarrattSchool of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.
Nigel K ArdenNuffield Department of Orthopaedics, University of Oxford, Oxford, UK.
Sofia Barbosa BouçasDepartment of Life Sciences, Brunel University, Uxbridge, UK.
Sarah BradleyOccupational Therapy Department, Poole Hospital NHS Foundation Trust, Poole, Poole, UK.
Michael DohertyMedicine, University of Nottingham, Nottingham, UK.
Susan DuttonCSM, University of Oxford, OXford, UK.
Krysia DziedzicArthritis Research Campaign National Primary Care Centre, Keele University, Stoke on Trent, Staffordshire, UK.
Rachael Gooberman-HillBristol Medical School, University of Bristol, Bristol, UK.
Kelly Hislop LennieSchool of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.
Corinne Hutt GreenyerSchool of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.
Victoria JansenPulvertaft Hand Centre, Royal Derby Hospital, Derby, UK.
Ramon Luengo-FernandezHealth Economics Research Centre, University of Oxford, Oxford, UK.
Claire MeagherSchool of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.
Peter WhiteSchool of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.
Mark WilliamsSport, Health Sciences and Social Work Department, Oxford Brookes University, Oxford, UK.ORCID 0000-0002-3488-847X
University of Southampton · GBUniversity of Oxford · GBBrunel University of London · GBKeele University · GBNuffield Orthopaedic Centre · GBOxford Brookes University · GBPoole Hospital NHS Foundation Trust · GBRoyal Derby Hospital · GBUniversity of Bristol · GBUniversity of Nottingham · GB

Funding

Arthritis Research UK 21019Department of Health CAT CDRF 10-018Department of Health KMRF-2014-03-002Department of Health RP-PG-0407-10386
6 · The paper itself

Abstract

introductionThe economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectiveness. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints. METHODS AND ANALYSIS: Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint. The primary outcome is the Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale. The study endpoint is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4, 8 and 12 weeks. Cost-effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise. ETHICS AND DISSEMINATION: South Central-Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions. TRIAL REGISTRATION NUMBER: ISRCTN54744256.

Indexed as

Pragmatic Clinical Trials as TopicSplintsCarpometacarpal JointsCost-Benefit AnalysisHumansMulticenter Studies as TopicOsteoarthritisPain MeasurementResearch DesignSelf-ManagementThumbUnited Kingdomhand functionhand painosteoarthritisplaceboself-managementsplintthumb base

Identifiers

PMID31640992
PMCPMC6830636
OpenAlexW2964152674

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.