Clinical trial NCT06138236: Plantar Fascitiis: Comparison of ESWT and Collagen Hydrolyzed Peptides
Official title: Comparison of ESWT and Collagen Hydrolyzed Peptides in the Treatment of Plantar Fascitiis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Plantar Fascitis
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients suffering from plantar fascitiis were randomized into three arms of treatment: Infiltration of collagen hydrolyzed peptides, ESWT and a combination of both treatments
Primary purpose: TREATMENT

Brief summary: Patients suffering from Plantar Fasciitis were randomized into three groups:

the first group underwent infiltration of Collagen Hydrolyzed Peptides, the second one underwent the ESWT treatment, the third one underwent a combination of the two treatments.

Detailed description: Patients suffering from Plantar Fasciitis were randomized into three groups:

the first group underwent infiltration of Collagen Hydrolyzed Peptides, the second one underwent the ESWT treatment, the third one underwent a combination of the two treatments.

Aim of the study was to consider any difference in the outcome of the three groups of patients. The NRS and the AFAS score were considered for the outcome measurement.

Eligibility criteria: Inclusion Criteria:

Plantar fascitiis Aged between 18 and 80 years old

Exclusion Criteria:

* Previous surgery of the foot
* Contraindications to ESWT

Primary outcomes:
measure: VAS (Visuoanalogic scale)
timeFrame: Between recruitment and 30 days
measure: AFAS (American Foot and Ankle Score) is the American Foot and Ankle Scale
timeFrame: Between Recruitment and 15 days
measure: AFAS is American Foot and Ankle Scale
timeFrame: Between Recruitment and 30 days
measure: AFAS is American Foot and Ankle Scale
timeFrame: Between Recruitment and 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Angela Notarnicola
Study officials:
affiliation: University of Bari
name: Silvana DE GIORGI, PI
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bari
name: Angela Notarnicola, AP
role: STUDY_CHAIR
References:
citation: Lai TW, Ma HL, Lee MS, Chen PM, Ku MC. Ultrasonography and clinical outcome comparison of extracorporeal shock wave therapy and corticosteroid injections for chronic plantar fasciitis: A randomized controlled trial. J Musculoskelet Neuronal Interact. 2018 Mar 1;18(1):47-54.
citation: Sun K, Zhou H, Jiang W. Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis. Foot Ankle Surg. 2020 Jan;26(1):33-38. doi: 10.1016/j.fas.2018.11.002. Epub 2018 Nov 13.
citation: Xu D, Jiang W, Huang D, Hu X, Wang Y, Li H, Zhou S, Gan K, Ma W. Comparison Between Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection for Plantar Fasciitis. Foot Ankle Int. 2020 Feb;41(2):200-205. doi: 10.1177/1071100719891111. Epub 2019 Nov 19.
citation: Melese H, Alamer A, Getie K, Nigussie F, Ayhualem S. Extracorporeal shock wave therapy on pain and foot functions in subjects with chronic plantar fasciitis: systematic review of randomized controlled trials. Disabil Rehabil. 2022 Sep;44(18):5007-5014. doi: 10.1080/09638288.2021.1928775. Epub 2021 May 26.