Plantar FasciitisPhase 3NCT01017406
Heel Cushion for Plantar Fasciitis
A Phase 3 study testing PSU heel cushion and plantar fascia specific stretching exercise in people with Plantar Fasciitis, run by Prince of Songkla University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- PSU heel cushion and plantar fascia specific stretching exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2010to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient with plantar fasciitis
Who cannot join
- Rheumatologic problem such as rheumatoid arthritis
- Latex allergy
- Pregnancy
- Previous surgery around foot and ankle
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Prince of Songkla university
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: 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.
- Conditions
- Plantar Fasciitis
- Being tested
- PSU heel cushion and plantar fascia specific stretching exercise
- Keywords
- plantar fasciitis, heel cushion, treatment
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSU heel cushion and plantar fascia specific stretching exerciseDevice
- Wear heel cushion during daily activity
- Plantar fascia stretching exercise 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| Plantar fascia stretching exercise | Experimental | Patient perform plantar fascia stretching 3 times per day Receives: Device: PSU heel cushion and plantar fascia specific stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Measured: 2 years
Secondary outcomes (4)
Compliance
Measured: 2 years
Satisfaction score
Measured: 2 years
Foot functional score : FHSQ score
Measured: 2 years
Number of rescue pain killer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Investigators
- Suntorn Wongsiri, MD., Principal investigator, Department of orthopedic surgery, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017406
- Sponsor's protocol ID
- 52-118-11-1-2
- Status last verified
- Jul 2011
- First submitted
- 17 Nov 2009
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSU Heel Cushion for Treatment of Plantar Fasciitis:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01017406
- Acronym / sponsor ID
- 52-118-11-1-2
- Conditions
- Plantar Fasciitis
- Keywords
- plantar fasciitis, heel cushion, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plantar fascia stretching exercise | Experimental | Device: PSU heel cushion and plantar fascia specific stretching exercisePatient perform plantar fascia stretching 3 times per day |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patient with plantar fasciitis
Key exclusion criteria (4 listed)
- Rheumatologic problem such as rheumatoid arthritis
- Latex allergy
- Pregnancy
- Previous surgery around foot and ankle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSU heel cushion and plantar fascia specific stretching exercise* Wear heel cushion during daily activity * Plantar fascia stretching exercise 3 times per day | Device | Plantar fascia stretching exercise |
Primary outcome
VAS score
Time frame: 2 years
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suntorn Wongsiri, MD. principal investigator
Department of orthopedic surgery, faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PSU heel cushion and plantar fascia specific stretching exercise in people with Plantar Fasciitis, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2011.