NCT01017406

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

Enrollment Period

2 years

First QC Date

November 17, 2009

Last Update Submit

July 26, 2011

Conditions

Plantar Fasciitis

Keywords

plantar fasciitisheel cushiontreatment

Outcome Measures

Primary Outcomes (1)

  • VAS score

    2 years

Secondary Outcomes (4)

  • Compliance

    2 years

  • Satisfaction score

    2 years

  • Foot functional score : FHSQ score

    2 years

  • Number of rescue pain killer

    2 years

Study Arms (1)

Plantar fascia stretching exercise

EXPERIMENTAL

Patient perform plantar fascia stretching 3 times per day

Device: PSU heel cushion and plantar fascia specific stretching exercise

Interventions

PSU heel cushion and plantar fascia specific stretching exerciseDEVICE

* Wear heel cushion during daily activity * Plantar fascia stretching exercise 3 times per day

Plantar fascia stretching exercise

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient with plantar fasciitis

You may not qualify if:

  • Rheumatologic problem such as rheumatoid arthritis
  • Latex allergy
  • Pregnancy
  • Previous surgery around foot and ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla university

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Suntorn Wongsiri, MD.

    Department of orthopedic surgery, faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 20, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

April 1, 2012

Last Updated

July 27, 2011

Record last verified: 2011-07

Locations

TH(1)