Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial.
Foot Health Status Questionnaire
Heavy-slow resistance training
Plantar fasciopathy
Radiofrequency microtenotomy
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
04 Oct 2022
04 Oct 2022
Historique:
received:
11
04
2022
accepted:
23
09
2022
entrez:
4
10
2022
pubmed:
5
10
2022
medline:
7
10
2022
Statut:
epublish
Résumé
Plantar 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. In 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. 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. ClinicalTrials.gov NCT03854682. Prospectively registered on February 26, 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Plantar 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.
METHODS
METHODS
In 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
CONCLUSIONS
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 REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03854682. Prospectively registered on February 26, 2019.
Identifiants
pubmed: 36195936
doi: 10.1186/s13063-022-06785-w
pii: 10.1186/s13063-022-06785-w
pmc: PMC9531425
doi:
Banques de données
ClinicalTrials.gov
['NCT03854682']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
845Informations de copyright
© 2022. The Author(s).
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