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NCT01017406 Clinical Trial

Heel Cushion for Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:
PSU Heel Cushion for Treatment of Plantar Fasciitis:A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01017406
Other study ID # 52-118-11-1-2
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received November 17, 2009
Last updated July 26, 2011
Start date January 2010
Est. completion date April 2012

Study information
Verified date July 2011
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 160
Est. completion date April 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 60 Years
Eligibility Inclusion Criteria:

- Patient with plantar fasciitis

Exclusion Criteria:

- Rheumatologic problem such as rheumatoid arthritis

- Latex allergy

- Pregnancy

- Previous surgery around foot and ankle

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• PSU heel cushion and plantar fascia specific stretching exercise
Wear heel cushion during daily activity Plantar fascia stretching exercise 3 times per day

Locations
Country Name City State
Thailand Prince of Songkla university Hatyai Songkhla

Sponsors (1)
Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAS score 2 years No
Secondary Compliance 2 years No
Secondary Satisfaction score 2 years No
Secondary Foot functional score : FHSQ score 2 years No
Secondary Number of rescue pain killer 2 years No
See also
  Status Clinical Trial Phase
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Unknown status NCT01882894 - Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment N/A
Terminated NCT01996111 - Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis N/A
Completed NCT01659827 - Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis N/A
Completed NCT00758641 - Platelet Rich Plasma to Treat Plantar Fasciitis Phase 4
Completed NCT00888394 - Effectiveness of Podiatry on Plantar Pain Phase 4
Terminated NCT00527748 - Foot and Ankle Range of Motion (Stretching) Apparatus N/A
Recruiting NCT05584046 - A Single-blind RCT to Investigate the Effect of a Novel Herbal Patch for the Treatment of PF N/A
Completed NCT04088383 - Amnios™ RT Outcomes Study N/A
Completed NCT01994759 - Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof. Phase 4
Completed NCT02646579 - Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only N/A
Completed NCT05592808 - Comparison of Taping Techniques in Plantar Fasciitis N/A
Not yet recruiting NCT04125264 - Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis N/A
Completed NCT02546089 - ABI v Dry Needling for Plantar Fasciitis N/A
Completed NCT00765843 - A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain N/A
Completed NCT00155324 - Change and Clinical Significance of Plantar Fascia Thickness After ESWT N/A
Completed NCT04941469 - Effectiveness of Specifically Optimized Off-the-counter Foot Orthosis for the Subtle Cavus Foot N/A
Completed NCT06055933 - Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis
Recruiting NCT02539082 - the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis Phase 4
Enrolling by invitation NCT01786057 - Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis Phase 2/Phase 3