Dataset Information

Comparison of the effect of hyaluronic acid injection versus extracorporeal shockwave therapy on chronic plantar fasciitis: Protocol for a randomized controlled trial.

ABSTRACT:

Background

Plantar fasciitis is the most common cause of pain in the plantar region of the heel, and extracorporeal shockwave therapy (ESWT) is an option used in cases where conservative treatment fails. Hyaluronic acid (HA), initially used for osteoarthrosis, is a treatment option because it has been applied to extra-articular regions, such as tendons, ligaments, and fascia. The aim of the present study will be to evaluate the outcomes of pain, function, and personal satisfaction after a single injection of HA and to compare the results with those of ESWT in patients with chronic plantar fasciitis.

Methods

The study will include 80 patients who will be randomized to receive three sessions of ESWT (n = 40) or a single ultrasound-guided HA injection in the plantar fascia (n = 40). The outcomes will include the visual analog pain scale score, American Orthopaedic Foot and Ankle Society (AOFAS) score, and Foot and Ankle Outcome Score (FAOS). All of the assessments will be performed at baseline and 3, 6, and 12 months after treatment. Statistical analysis will be performed using the repeated measures ANOVA (analysis of variance test) for primary and secondary outcomes and also Fisher's Least Significant Difference, a Post-Hoc test. We will use R software for statistical analysis, randomization, and sample size calculation.

Results

Recruitment and data collection will begin in November 2020, with completion scheduled for November 2022 and final publication available in March 2023.

Conclusion

This trial will evaluate the effects of a single ultrasound-guided HA injection for the treatment of chronic plantar fasciitis.

Trial registration

Brazilian Clinical Trials Registry (Register Number: RBR-97vkx4) http://www.ensaiosclinicos.gov.br/rg/RBR-97vkx4/.

SUBMITTER: Ferreira GF

PROVIDER: S-EPMC8224905 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:The objective of this study was to assess the efficacy of different energy levels used in extracorporeal shockwave therapy (ESWT) in the treatment of plantar fasciitis using a systematic review and meta-analysis. We searched PubMed, Embase, and Cochrane library, from inception to March 2019 for randomized controlled trials that compared ESWT with placebo in patients with plantar fasciitis. The risk of bias for selected articles was assessed based on the Cochrane Handbook Systematic Review of Interventions. The pooled data were estimated by the mean difference or odds ratio. The meta-analysis showed that the high-energy ESWT group had a better success rate than the control group only at a three-month follow-up, but no significant difference between groups was observed for the other follow-up visits (1 and 12 months). In addition, no significant differences in visual analog scale (VAS) scores between groups were observed for all the follow-up visits (one-month and three-month). On the contrary, the medium-energy ESWT group had significantly better success rates than the control group for all the follow-up visits (3, 6, and 12 months). In addition, the medium-energy ESWT group had significant improvement in VAS scores compared with the control group for all the follow-up visits (1, 3, 6, and 12 months) after removing the extreme values. The low-energy ESWT group had significant improvement in VAS scores compared with the control group for all the follow-up visits (3 and 12 months). Otherwise, focused ESWT seems to be more effective than radial ESWT when compared with the control group. Use of local anesthesia can reduce the efficacy of low- and high-energy ESWTs. Our meta-analysis suggested that medium-energy ESWT in the treatment of plantar fasciitis was more effective than the control group. A limited number of trials related to low- and high-energy ESWTs were included in our meta-analysis. More research is required to confirm the efficacy of low- and high-energy ESWTs in future studies.