Heel Cushion for Plantar Fasciitis

Phase 3

• Conditions: Plantar Fasciitis
• Interventions: Device: PSU heel cushion and plantar fascia specific stretching exercise

• Registration Number: NCT01017406
• Lead Sponsor: Prince of Songkla University

Brief Summary

The investigators study aim to evaluate the efficacy of PSU heel cushion in treatment of plantar fasciitis. The investigators will do a randomized controlled trial in patient with plantar fasciitis compared with stretching exercise alone. The outcome measurement include heel pain improvement, compliance, satisfaction, foot functional score at 6 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2010-01
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-26
• Last Update Posted: 2011-07-27
• Primary Completion: 2012-01
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patient with plantar fasciitis

Exclusion Criteria

• Rheumatologic problem such as rheumatoid arthritis
• Latex allergy
• Pregnancy
• Previous surgery around foot and ankle

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plantar fascia stretching exercise	PSU heel cushion and plantar fascia specific stretching exercise	Patient perform plantar fascia stretching 3 times per day

Primary Outcome Measures

Name	Time	Method
VAS score	2 years

Secondary Outcome Measures

Name	Time	Method
Compliance	2 years
Satisfaction score	2 years
Foot functional score : FHSQ score	2 years
Number of rescue pain killer	2 years

Trial Locations

Locations (1)

Prince of Songkla university; 🇹🇭 Hatyai, Songkhla, Thailand