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Heel Cushion for Plantar Fasciitis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01017406
First received: November 17, 2009
Last updated: July 26, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Plantar Fasciitis
 Device: PSU heel cushion and plantar fascia specific stretching exercise
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PSU Heel Cushion for Treatment of Plantar Fasciitis:A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • VAS score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Satisfaction score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Foot functional score : FHSQ score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of rescue pain killer [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plantar fascia stretching exercise
Patient perform plantar fascia stretching 3 times per day
 Device: PSU heel cushion and plantar fascia specific stretching exercise
  • Wear heel cushion during daily activity
  • Plantar fascia stretching exercise 3 times per day

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with plantar fasciitis

Exclusion Criteria:

  • Rheumatologic problem such as rheumatoid arthritis
  • Latex allergy
  • Pregnancy
  • Previous surgery around foot and ankle
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017406

Locations
Thailand
Prince of Songkla university
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Suntorn Wongsiri, MD. Department of orthopedic surgery, faculty of medicine
  More Information

No publications provided

Responsible Party: Boonsin Tangtrakulwanich, Department of Orthopedic Surgery, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01017406     History of Changes
Other Study ID Numbers: 52-118-11-1-2
Study First Received: November 17, 2009
Last Updated: July 26, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
plantar fasciitis
heel cushion
treatment

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on May 16, 2013