Heel Cushion for Plantar Fasciitis

NCT ID: NCT01017406

Last Updated: 2011-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-04-30

Brief Summary

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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

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Conditions

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Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Plantar fascia stretching exercise

Patient perform plantar fascia stretching 3 times per day

Group Type EXPERIMENTAL

PSU heel cushion and plantar fascia specific stretching exercise

Intervention Type DEVICE

* Wear heel cushion during daily activity
* Plantar fascia stretching exercise 3 times per day

Interventions

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PSU heel cushion and plantar fascia specific stretching exercise

* Wear heel cushion during daily activity
* Plantar fascia stretching exercise 3 times per day

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient with plantar fasciitis

Exclusion Criteria

* Rheumatologic problem such as rheumatoid arthritis
* Latex allergy
* Pregnancy
* Previous surgery around foot and ankle
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Department of Orthopedic Surgery, Faculty of Medicine

Principal Investigators

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Suntorn Wongsiri, MD.

Role: PRINCIPAL_INVESTIGATOR

Department of orthopedic surgery, faculty of medicine

Locations

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Prince of Songkla university

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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52-118-11-1-2

Identifier Type: -

Identifier Source: org_study_id

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