Chronic Plantar FasciitisNCT01981226
Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
A study testing Extracoporeal shock wave in people with Chronic Plantar Fasciitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography of the plantar fascia was checked. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plantar Fasciitis
- What is being tested?
- Extracoporeal shock wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Sep 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain for more than 6 months，poor response to the conservative treatments
- Sonography showed plantar fasciitia>4.0mm)
Who cannot join
- Acute infection of soft tissue/bone
- Malignant primary disease
- Blood coagulation disorders
- Pregnancy
- Patients with pacemaker
- foot deformity
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Natinal Taiwan University Hospital
Taipei, Taiwan, 100
Yun-yi Lin, M.D., +886972655935, doc9775c@yahoo.com.tw
About this study
Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness increased after ESWT as clinical symptom improves.
Read the detailed description
For patient who met the inclusion criteria, we check sonography and sonoelastography for their plantar fascias and obtain a thorough evulation questionaire for clinical symptom and pain condition and intensity in various conditions, also SF-36 questionaire first. Inform consent was done.
After the ESWT, we follow patient with questionaire and sonography/sonoelastography at 1-week, 1-month, 3-month, 6-month, 9-month, and 12-month post-ESWT time.
The colored sonoelastographic image was analysed by computer software "Image-J" with hue analysis method and relative stiffness of selected area within proximal plantar fascia wasa obtained for statistical analysis.
- Conditions
- Chronic Plantar Fasciitis
- Being tested
- Extracoporeal shock wave
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracoporeal shock waveDevice
Extracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency：2-4Hz, energy level:0.8-1.0 mJ/mm2
| Study group | Role | What they receive |
|---|---|---|
| Extracoporeal shock wave | Experimental | Extracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency：2-4Hz, energy level:0.8-1.0 mJ/mm2 Receives: Device: Extracoporeal shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonoelastographic changes of plantar fascia after ESWT
Measured: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month
Secondary outcomes (1)
Plantar fascia thickness
Measured: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startSep 2010
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981226
- Sponsor's protocol ID
- 201007055R
- Status last verified
- Nov 2013
- First submitted
- 5 Nov 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT01981226
- Acronym / sponsor ID
- 201007055R
- Conditions
- Chronic Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (estimated)
- First posted
- 11 Nov 2013 (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.
Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness increased after ESWT as clinical symptom improves.
Detailed description
For patient who met the inclusion criteria, we check sonography and sonoelastography for their plantar fascias and obtain a thorough evulation questionaire for clinical symptom and pain condition and intensity in various conditions, also SF-36 questionaire first. Inform consent was done.
After the ESWT, we follow patient with questionaire and sonography/sonoelastography at 1-week, 1-month, 3-month, 6-month, 9-month, and 12-month post-ESWT time.
The colored sonoelastographic image was analysed by computer software "Image-J" with hue analysis method and relative stiffness of selected area within proximal plantar fascia wasa obtained for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracoporeal shock wave | Experimental | Device: Extracoporeal shock waveExtracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency：2-4Hz, energy level:0.8-1.0 mJ/mm2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pain for more than 6 months，poor response to the conservative treatments
- Sonography showed plantar fasciitia>4.0mm)
Key exclusion criteria (6 listed)
- Acute infection of soft tissue/bone
- Malignant primary disease
- Blood coagulation disorders
- Pregnancy
- Patients with pacemaker
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 |
|---|---|---|
| Extracoporeal shock waveExtracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency：2-4Hz, energy level:0.8-1.0 mJ/mm2 | Device | Extracoporeal shock wave |
Primary outcome
Sonoelastographic changes of plantar fascia after ESWT
Time frame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month
1 secondary outcome
Plantar fascia thickness
Time frame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracoporeal shock wave in people with Chronic Plantar Fasciitis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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 11 Nov 2013. 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 Taiwan. 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.
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?
Contact Yun-Yi Lin, M.D. (+886972653424, doc9775c@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonoelastographic changes of plantar fascia after ESWT (time frame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month). 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 11 Nov 2013.