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Heel Cushion for Plantar Fasciitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Prince of Songkla University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017406
First Posted: November 20, 2009
Last Update Posted: July 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Prince of Songkla University
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PSU Heel Cushion for Treatment of Plantar Fasciitis:A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • VAS score [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Compliance [ Time Frame: 2 years ]
  • Satisfaction score [ Time Frame: 2 years ]
  • Foot functional score : FHSQ score [ Time Frame: 2 years ]
  • Number of rescue pain killer [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 17, 2009
First Posted: November 20, 2009
Last Update Posted: July 27, 2011
Last Verified: July 2011

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

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