Efficacy of the Treatment of Plantar Orthoses With Extrac... | NCT04461197

Studies
Efficacy of the Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis

NCT04461197

Sponsor

University of Seville

Status

Completed

Last Update Posted

Apr 14, 2021Actual

Enrollment

76Actual

Phase

Not Applicable

Conditions

Fasciitis, Plantar, Chronic

Interventions

customised foot orthoses
orthotic insole

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2019Actual

Primary Completion Date

May 15, 2020Actual

Completion Date

Jun 15, 2020Actual

First Submitted Date

Jun 26, 2020

First Submission Date that Met QC Criteria

Jul 1, 2020

First Posted Date

Jul 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2021

Last Update Posted Date

Apr 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports. ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be radial or focused. The aim of this study was to evaluate the effectiveness of the adjuvant use of plantar orthoses in the process of plantar fasciitis when extracorporeal shock waves are applied. The hypothesis porposed was that the use of extracorporeal shock waves together with the use of custom foot orthotics improves the symptoms produced by plantar fasciitis. This study is planned as double-blind, randomized controlled trial. Participants are randomly allocated to two groups: the ESWT group and the custom foot orthotics and ESWT group. Radial ESWT will be applied in this study.

The people receiving the therapy and the people assessing the outcomes are blinded . Both group will recieve ESWT one session per week for three weeks. Each session will last for 2-5 minutes. The primary outcome measure of this study is change in heel pain of affected side assessed using Visual Analog Scale. The secondary outcome measure is Roles y Maudsley scores. The primary endpoint of this study is to determine a decrease in pain score according to Visual Analog Scale.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESWT + orthotic insole	Experimental	(shock waves + orthotic insole +Stretches of the posterior muscle chain)	Device: customised foot orthoses
ESWT + flat insole	Placebo Comparator	(shock waves + flat insole + Stretches of the posterior muscle chain)	Device: orthotic insole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
customised foot orthoses	Device	The foot orthoses for group A were custom made using phenolic foam molds of the feet. Separated molds were made of both feet for all the participants. . The insole was made based on a positive mold of plaster with 45 Shore cork materials with horizontal thrusts just proximal to the metatarsal heads, with the intention of correcting the pathological subtalar pronation, with a 3mm bilateral raising of the heel and a bilateral latex metatarsal bar.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual analog scale (VAS)	Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Roles-Maudsley (RM) scores	This is a self-administered scale of functional valuation which classifies the patients into 4 categories	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 - 65 years
able to understand the explanations about the potential benefits and risks of participating in the study
both genders
diagnosis of chronic plantar fasciitis
duration of symptoms equal or superior to 6 months at the time of enrollment
Foot Posture Index ≥ +6 (pronated foot in one or both feet).

Exclusion Criteria:

being younger than 18 years of age
previous treatments with shock wave devices
previous surgery on the painful heel; history of calcaneus fracture
any inflammation at the level of the ankle
infection in the treated area
patients with diabetes mellitus or cardiac or respiratory disease
osteomyelitis
patients on anticoagulant drugs
pregnancy
patients on immunosuppressive therapy
rheumatoid arthritis or history of rheumatic disease
neurological deficits
malignant disease with or without metastases
significant liver function abnormalities
neurological or vascular insufficiency in the painful heel; fasciotomy or heel spur surgery
discrepancy in the length of the foot > 5 mm; previous back of foot surgery
patients treated with rigid plantar supports

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ana J Perez, Dra.	University of Seville	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D036981	Fasciitis, Plantar

ID	Term
D005208	Fasciitis
D009140	Musculoskeletal Diseases
D005534	Foot Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D061826	Foot Orthoses

Ancestor Terms

ID	Term
D009989	Orthotic Devices
D009983	Orthopedic Equipment
D013523	Surgical Equipment
D004864	Equipment and Supplies

Browse Leaves

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Browse Branches

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