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

November 17, 2009
July 26, 2011
January 2010
January 2012   (final data collection date for primary outcome measure)
VAS score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017406 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Heel Cushion for Plantar Fasciitis
PSU Heel Cushion for Treatment of Plantar Fasciitis:A Randomized Controlled Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Plantar Fasciitis
Device: PSU heel cushion and plantar fascia specific stretching exercise
  • Wear heel cushion during daily activity
  • Plantar fascia stretching exercise 3 times per day
Experimental: Plantar fascia stretching exercise
Patient perform plantar fascia stretching 3 times per day
Intervention: Device: PSU heel cushion and plantar fascia specific stretching exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
160
April 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient with plantar fasciitis

Exclusion Criteria:

  • Rheumatologic problem such as rheumatoid arthritis
  • Latex allergy
  • Pregnancy
  • Previous surgery around foot and ankle
Both
15 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01017406
52-118-11-1-2
No
Boonsin Tangtrakulwanich, Department of Orthopedic Surgery, Faculty of Medicine
Prince of Songkla University
Not Provided
Principal Investigator: Suntorn Wongsiri, MD. Department of orthopedic surgery, faculty of medicine
Prince of Songkla University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP