Evidence map›Paper›PMID 36195936›Full record

ArticleTrials2022

Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial.

Stefan Møller, Henrik Riel, Jens Wester, Ane Simony, Bjarke Viberg, Carsten Jensen

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03854682 (Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT03854682 nacompletednot on this map

Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial

TypeinterventionalSponsorUniversity of Southern DenmarkRan2020 to 2025Enrolled70ConditionsFasciitis, Plantar, ChronicArmsRadiofrequency microtenotomy, Strength training
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. 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

6 authors.

Stefan MøllerDepartment of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital - University Hospital of Southern Denmark, Sygehusvej 24, 6000, Kolding, Denmark. stefan.moller@rsyd.dk.
Henrik RielCenter for General Practice at Aalborg University, Fyrkildevej 7, 9220, Aalborg, Denmark.
Jens WesterDepartment of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital - University Hospital of Southern Denmark, Sygehusvej 24, 6000, Kolding, Denmark.
Ane SimonyDepartment of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital - University Hospital of Southern Denmark, Sygehusvej 24, 6000, Kolding, Denmark.
Bjarke VibergDepartment of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital - University Hospital of Southern Denmark, Sygehusvej 24, 6000, Kolding, Denmark.
Carsten JensenDepartment of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital - University Hospital of Southern Denmark, Sygehusvej 24, 6000, Kolding, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlantar fasciopathy is the most common reason for complaints of plantar heel pain and one of the most prevalent musculoskeletal conditions with a reported lifetime incidence of 10%. The condition is normally considered self-limiting with persistent symptoms that often last for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. Heavy-slow resistance training and radiofrequency microtenotomy for the treatment of plantar fasciopathy have shown potentially positive effects on short- and long-term outcomes (> 3 months). However, the effect of heavy-slow resistance training compared with a radiofrequency microtenotomy treatment is currently unknown. This trial compares the efficacy of heavy-slow resistance training and radiofrequency microtenotomy treatment with supplemental standardized patient education and heel inserts in improving the Foot Health Status Questionnaire pain score after 6 months in patients with plantar fasciopathy.

methodsIn this randomized superiority trial, we will recruit 70 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of two groups: (1) heavy-slow resistance training, patient education and a heel insert (n = 35), and (2) radiofrequency microtenotomy treatment, patient education and a heel insert (n = 35). All participants will be followed for 1 year, with the 6-month follow-up considered the primary endpoint. The primary outcome is the Foot Health Status Questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a Global Perceived Effect scale, the physical activity level, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment. DISCUSSION: By comparing the two treatment options, we should be able to answer if radiofrequency microtenotomy compared with heavy-slow resistance training is superior in patients with plantar fasciopathy.

trial registrationClinicalTrials.gov NCT03854682. Prospectively registered on February 26, 2019.

Indexed as

Fasciitis, PlantarResistance TrainingHumansPainPain MeasurementRandomized Controlled Trials as TopicSurveys and QuestionnairesTreatment OutcomeFoot Health Status QuestionnaireHeavy-slow resistance trainingPlantar fasciopathyRadiofrequency microtenotomy

Identifiers

PMID36195936
PMCPMC9531425

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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.