Plantar FasciitisPhase 4NCT02608723
Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes?
A Phase 4 study testing Standard shock waves device, Austere shock waves device and Sophisticated shock waves device in people with Plantar Fasciitis and Pain, run by Asociacion Colaboracion Cochrane Iberoamericana at 1 site in Spain.
Trial summary
To check in patients suffering from chronic plantar fasciitis treated with shock wave therapy, if the outward appearance of the device affects clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis, Pain
- What is being tested?
- Standard shock waves device, Austere shock waves device and Sophisticated shock waves device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to Jun 2015
- Phase
- Phase 4
- 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
- Age greater than 18 years.
- Being able to understand the explanations about the potential benefits and risks of study participation.
- Diagnosis of chronic plantar fasciitis. Proven by clinical examination: Meeting at least 2 of the following criteria:
- Tenderness in the proximal insertion of the plantar fascia (area of the medial calcaneal tuberosity).
- Pain during the first steps to get out of bed in the morning and / or after a period of rest time.
- With a duration of symptoms ≥ 6 months at the time of study entry.
- Having received conservative therapy without success, at least two treatments. Treatments may have been made isolated, combined or consecutively.
Who cannot join
- Bilateral plantar fasciitis.
- Hiper/ hypothyroidism.
- Diabetes mellitus.
- Treatment with anticoagulants
- Inflammatory diseases.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Rehabilitation Center "Salut i Esport"
Santa Perpètua de Gaià, Barcelona, 08130
About this study
Official title: Chronic Plantar Fasciitis Treated With Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes? A Randomized Controlled Clinical Trial.
To check in patients suffering from chronic plantar fasciitis treated with shock wave therapy, if the outward appearance of the device affects clinical outcomes.
Read the detailed description
Study Design: a controlled, randomized, parallel assessor-blinded clinical trial.
Patients suffering from chronic plantar fasciitis (duration more than 6 months) will be assigned to three different groups:
- Group I: Treatment applied by standard shock waves device.
- Group II: Shock wave therapy applied by a modified standard device to offer more attractive, more technical, smarter, better appearance, larger and with an expansion of external information devices more sophisticated.
- Group III: Shock wave therapy applied by a modified standard device to offer a more austere, disfigured, unattractive, modest and smaller external appearance.
The shock waves emitted to the 3 devices will be identical; the only difference will be the external image of the device.
The main outcome will be the function of the foot by the FFI (Foot Function Index) questionnaire.
As secondary variables: pain by VAS (Visual Analogical Scale) in different situations, the plantar fascia thickness measured by ultrasound, and the perception of patient recovery measured with the Likert scale. Adverse effects, painkillers consumption and pain experienced during the treatment of shock waves were also assessed.
The patients will be followed and monitored for a month, two months and four months after treatment finished.
For the statistical analysis of clinical variables, ANOVA (analysis of variance) will be performed to check whether the evolution of patients over time was different depending on the device applied.
- Conditions
- Plantar Fasciitis, Pain
- Being tested
- Standard shock waves device, Austere shock waves device, Sophisticated shock waves device
- Keywords
- shock wave, plantar fasciitis, placebo effect, nocebo effect
- Medical subject headings
- Fasciitis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard shock waves deviceDevice
3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
Austere shock waves deviceDevice
3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
Sophisticated shock waves deviceDevice
3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
| Study group | Role | What they receive |
|---|---|---|
| Standard shock waves device | Active comparator | 3 sessions were applied: one per week. Receives: Device: Standard shock waves device |
| Austere shock waves device | Active comparator | 3 sessions were applied: one per week. Receives: Device: Austere shock waves device |
| Sophisticated shock waves device | Active comparator | 3 sessions were applied: one per week. Receives: Device: Sophisticated shock waves device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function of the foot
FFI (Foot Function Index) questionnaire
Measured: Four months
Secondary outcomes (5)
Pain
VAS (Visual Analogical Scale)
Measured: Four months
Plantar fascia thickness
Ultrasounds
Measured: Four months
Perception of patient recovery
Likert scale
Measured: Four months
Painkillers consumption
Painkillers consumption
Measured: Four months
Adverse effects
Adverse effects
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociacion Colaboracion Cochrane Iberoamericana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoni Morral, PhDc, Principal investigator, Rehabilitation Center "Salut i Esport"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608723
- Sponsor's protocol ID
- 1304
- Status last verified
- Nov 2015
- First submitted
- 13 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Plantar Fasciitis Treated With Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes? A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02608723
- Acronym / sponsor ID
- 1304
- Conditions
- Plantar Fasciitis, Pain
- Keywords
- shock wave, plantar fasciitis, placebo effect, nocebo effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Asociacion Colaboracion Cochrane IberoamericanaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Nov 2015 (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.
To check in patients suffering from chronic plantar fasciitis treated with shock wave therapy, if the outward appearance of the device affects clinical outcomes.
Detailed description
Study Design: a controlled, randomized, parallel assessor-blinded clinical trial.
Patients suffering from chronic plantar fasciitis (duration more than 6 months) will be assigned to three different groups:
- Group I: Treatment applied by standard shock waves device.
- Group II: Shock wave therapy applied by a modified standard device to offer more attractive, more technical, smarter, better appearance, larger and with an expansion of external information devices more sophisticated.
- Group III: Shock wave therapy applied by a modified standard device to offer a more austere, disfigured, unattractive, modest and smaller external appearance.
The shock waves emitted to the 3 devices will be identical; the only difference will be the external image of the device.
The main outcome will be the function of the foot by the FFI (Foot Function Index) questionnaire.
As secondary variables: pain by VAS (Visual Analogical Scale) in different situations, the plantar fascia thickness measured by ultrasound, and the perception of patient recovery measured with the Likert scale. Adverse effects, painkillers consumption and pain experienced during the treatment of shock waves were also assessed.
The patients will be followed and monitored for a month, two months and four months after treatment finished.
For the statistical analysis of clinical variables, ANOVA (analysis of variance) will be performed to check whether the evolution of patients over time was different depending on the device applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard shock waves device | Active comparator | Device: Standard shock waves device3 sessions were applied: one per week. |
| Austere shock waves device | Active comparator | Device: Austere shock waves device3 sessions were applied: one per week. |
| Sophisticated shock waves device | Active comparator | Device: Sophisticated shock waves device3 sessions were applied: one per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than 18 years.
- Being able to understand the explanations about the potential benefits and risks of study participation.
- Diagnosis of chronic plantar fasciitis. Proven by clinical examination: Meeting at least 2 of the following criteria:
- With a duration of symptoms ≥ 6 months at the time of study entry.
- Having received conservative therapy without success, at least two treatments. Treatments may have been made isolated, combined or consecutively.
Key exclusion criteria (5 listed)
- Bilateral plantar fasciitis.
- Hiper/ hypothyroidism.
- Diabetes mellitus.
- Treatment with anticoagulants
- Inflammatory diseases.
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 |
|---|---|---|
| Standard shock waves device3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device. | Device | Standard shock waves device |
| Austere shock waves device3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device. | Device | Austere shock waves device |
| Sophisticated shock waves device3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device. | Device | Sophisticated shock waves device |
Primary outcome
Function of the foot
Time frame: Four months
FFI (Foot Function Index) questionnaire
5 secondary outcomes
Pain
Time frame: Four months
Plantar fascia thickness
Time frame: Four months
Perception of patient recovery
Time frame: Four months
Painkillers consumption
Time frame: Four months
Adverse effects
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
Antoni Morral, PhDc principal investigator
Rehabilitation Center "Salut i Esport"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard shock waves device, Austere shock waves device and Sophisticated shock waves device in people with Plantar Fasciitis and Pain, run by Asociacion Colaboracion Cochrane Iberoamericana at 1 site in Spain.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 20 Nov 2015. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Function of the foot (time frame: Four months). 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 20 Nov 2015.