Back to resultsHeel Cushion for Plantar Fasciitis
Primary Purpose
Plantar Fasciitis
Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
PSU heel cushion and plantar fascia specific stretching exercise
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis focused on measuring plantar fasciitis, heel cushion, treatment
Eligibility Criteria
Inclusion Criteria:
- Patient with plantar fasciitis
Exclusion Criteria:
- Rheumatologic problem such as rheumatoid arthritis
- Latex allergy
- Pregnancy
- Previous surgery around foot and ankle
Sites / Locations
- Prince of Songkla university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plantar fascia stretching exercise
Arm Description
Patient perform plantar fascia stretching 3 times per day
Outcomes
Primary Outcome Measures
VAS score
Secondary Outcome Measures
Compliance
Satisfaction score
Foot functional score : FHSQ score
Number of rescue pain killer
Full Information
NCT ID
NCT01017406
First Posted
November 17, 2009
Last Updated
July 26, 2011
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01017406
Brief Title
Heel Cushion for Plantar Fasciitis
Official Title
PSU Heel Cushion for Treatment of Plantar Fasciitis:A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
plantar fasciitis, heel cushion, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plantar fascia stretching exercise
Arm Type
Experimental
Arm Description
Patient perform plantar fascia stretching 3 times per day
Intervention Type
Device
Intervention Name(s)
PSU heel cushion and plantar fascia specific stretching exercise
Intervention Description
Wear heel cushion during daily activity
Plantar fascia stretching exercise 3 times per day
Primary Outcome Measure Information:
Title
VAS score
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Compliance
Time Frame
2 years
Title
Satisfaction score
Time Frame
2 years
Title
Foot functional score : FHSQ score
Time Frame
2 years
Title
Number of rescue pain killer
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with plantar fasciitis
Exclusion Criteria:
Rheumatologic problem such as rheumatoid arthritis
Latex allergy
Pregnancy
Previous surgery around foot and ankle
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suntorn Wongsiri, MD.
Organizational Affiliation
Department of orthopedic surgery, faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla university
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
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Heel Cushion for Plantar Fasciitis
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