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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Foot Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 20, 2014