comparison between different types of gastrocnemius-soleus stretching in the treatment of plantar fasciitis: posterior night splint, soft night splint of a custom-made cast.

Completed

• Conditions: plantar fasciitis; plantar heel pain; 10043237

• Registration Number: NL-OMON52618
• Lead Sponsor: Reinier Haga Orthopedisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-07-09
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 81

Inclusion Criteria

• Age over 18 years
• Patient with, the subjective and objective signs and symptoms of mechanical
plantar fasciitis
• Patients who speak and/or understand Dutch
• Patient who are able and willing to participate in a treatment for 6 months.

Exclusion Criteria

• Subject is not able to complete the daily questionnaires in Dutch or not
being able to fill in the Dutch Questionnaires.
• Patients with heel pain from causes other than plantar fasciitis
• Patients with a history of heel fracture or heel surgery, and systemic
inflammatory arthritis.
• Subject, in the opinion of the investigator, is not able to understand this
investigation and is not willing and able to perform all study procedures and
co-operate with investigational procedures.
• Subject was diagnosed and is taking prescription medications to treat a
muscular disorder that limits mobility due to severe stiffness and pain such as
fibromyalgia or polymyalgia.
• Subject has participated in a clinical investigation with an investigational
product (drug or device) in the last three months.
• Subject has refused voluntary, written informed consent to participate in
this randomized controlled trial

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary endpoint is pain measured with a Numeric Rating Scale (NRS first<br /><br>step pain) at 3 months after starting treatment between the three stretching<br /><br>orthesis.<br /><br><br /><br>Primary Objective:<br /><br>Is there a minimal important difference in pain level (NRS first step pain)<br /><br>between subjects with plantar fasciitis receiving a posterior tension night<br /><br>splint (Pro Orthic), soft night splint (Strassburg sock) or custom made cast<br /><br>after 3 months?</p><br>