ArticleNIHR open research2025
Clinical and cost-effectiveness of individualised exercises and foot orthoses in the treatment of plantar heel pain: protocol for the TREADON randomised multi-arm multi-stage adaptive trial.
Article in NIHR open research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Plantar heel pain (PHP) is the most common soft tissue foot condition and impairs mobility, physical function, ability to work, and quality of life. Systematic reviews highlight a need for high-quality randomised controlled trials (RCTs) of exercises and orthoses for PHP. Objectives: To determine the clinical and cost-effectiveness of individualised exercises and/or prefabricated foot orthoses plus self-management advice (SMA) compared to SMA alone in adults with PHP. Methods: A multi-centre four-arm two-stage adaptive parallel-group RCT with internal pilot. Up to 696 participants aged ≥18 years with PHP will be identified from general practice, physiotherapy/podiatry referrals and self-referral, and randomised 1:1:1:1 to: (1) SMA (control), (2) SMA plus individualised exercises, (3) SMA plus prefabricated foot orthoses, or (4) SMA plus individualised exercises and prefabricated foot orthoses. Outcomes will be collected by SMS text-message (weekly during weeks 1-12, monthly during months 4-12) and questionnaires at 12 weeks and 6 and 12 months. The primary outcome is change in PHP intensity (0-10 numeric rating scale) between baseline and the average over 6-12 weeks. Interim analysis when 348 participants have completed the primary outcome assessment will inform adaptation, where interventions may be dropped or the trial stopped early (for efficacy or futility). The main between-group comparison for the primary outcome will be undertaken using linear mixed modelling. Secondary outcomes will examine i) short-term pain trajectories over weeks 1-12, ii) pain at 6 and 12 months, and monthly from 3-12 months, iii) first step pain, physical function, global rating of change, pain self-efficacy, illness perceptions, ability to work, and treatment satisfaction at 12 weeks, 6 and 12 months, iv) cost-effectiveness. Patient and public partner involvement is embedded throughout. Discussion: The TREADON multi-arm multi-stage RCT will provide new evidence on the clinical and cost-effectiveness of individualised exercises and prefabricated foot orthoses for people with PHP. Trial registration:
Indexed as
Identifiers
What OpenQuestion holds
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.