Heel SpurNCT02934100
Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur
A study testing Shock Master 300, Skanlab 25 BODYWAVE and EVO US13 CosmoGamma in people with Heel Spur and Calcaneal Spur, run by Medical University of Lodz at 1 site in Poland.
Trial summary
This study evaluates the effectiveness of physiotherapy and kinesiotherapy in patients with calcaneal spurs. the aim of the study is to compare the efficacy of calcaneal spurs treatment provided with extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy associated with kinesiotherapy and sham… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Heel Spur, Calcaneal Spur
- What is being tested?
- Shock Master 300, Skanlab 25 BODYWAVE and EVO US13 CosmoGamma
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2016to Jun 2018
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- heel spur (calcaneal spur) diagnosed by a doctor based on X-ray examination, diagnostic ultrasonography or MR
- signed informed consent
- heel pain for at least one month
Who cannot join
- pregnancy
- generalized acute infection (fever, cough, runny nose)
- local infection in the treated leg (wound, swelling)
- cancer
- injections of corticosteroids in the last six weeks
- pacemaker
Show all 29Show fewer
- acute inflammation of the joints of the lower limbs
- inflammation of the veins
- Fresh fractures, post-traumatic
- osteoporosis
- Reynaud's disease
- Burger disease
- atherosclerosis
- after surgery condition before removing stitches
- High blood pressure
- after CT with contrast condition in the last two weeks
- The state of the lumbar puncture
- Strong imbalance
- Condition after myocardial infarction in the last six weeks
- Rheumatoid arthritis
- Ankylosing spondylitis
- Significant leg ulcers
- diabetes
- The risk of bleeding in the muscle tissue
- Thromboangiitis
- Hypersensitivity skin in the treated section
- A tendency to hemorrhage
- Pathological arrogance bone under the skin in the treated section
- Metal implants and surgical implants in the area of the lower limb subjected to therapy
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Non-public health care facility "NZOZ Komed"
Lodz, Łódź Voivodeship, 90-009
Natalia Kociuga, master, +48609018609, nkociuga@gmail.com
Marta Woldańska-Okońska, Professor, +48662130860, marta.woldanska-okonska@umed.lodz.pl
About this study
This study evaluates the effectiveness of physiotherapy and kinesiotherapy in patients with calcaneal spurs. the aim of the study is to compare the efficacy of calcaneal spurs treatment provided with extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy associated with kinesiotherapy and sham laser in combination with kinesiotherapy. In each group kinesiotherapy treatment is the same and consists of an eight-minute massage of posterior lower leg muscles and plantar aponeurosis stretching.
Read the detailed description
Number of 120 diagnosed with heel spur patients, will be allocated randomly into one of three treatment groups or into the control group. Assignment to a group is random, but before that happens patients will be questioned about inclusion and exclusion criteria of the study. Depending on group allocation, patients in treatment groups will receive one of the following physical therapy treatments:
- ESWT (once a week for 10 weeks)
- ultrasound (three times a week for 5 weeks)
- electric field diathermy (three times a week for 5 weeks).
Patients allocated in control group, will receive a sham laser therapy (only the timer on the machine activated) three times a week for 5 weeks.
Regardless of affiliation to the group, each patient will also receive kinesiotherapy treatment.
At the beginning of the study, each patient receives the "Information for the patient," describing the exact course of each stage of the study, then signs a "Form of informed consent to participate in the study.". The next stage of the study is to fill in the participant survey questionnaire and physical examination provided by the researcher.
Assessment of improvements will be made twice: right after the therapy and two months later. Every stage of the study is carried out by one and the same investigator.
- Conditions
- Heel Spur, Calcaneal Spur
- Being tested
- Shock Master 300, Skanlab 25 BODYWAVE, EVO US13 CosmoGamma, Sham LASER CTL1106MX
- Keywords
- Calcaneal spur, Heel spur, ESWT, Extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy, skanlab 25 bodywave, sham laser therapy
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock Master 300Device
Also called produced by GYMNA
Extracorporeal Shock Wave Therapy
In all treatments (from 1 to 10) applied number of pulses is 4500 and the frequency is based on the patients feelings (from 8 to 12 Hz). Variable is the pressure:
Treatment 1 - 2,5 Bar; Treatment 2 - 2,6 Bar; Treatment 3 - 2,7 Bar; Treatment 4 - 2,8 Bar; Treatment 5 - 3,0 Bar; Treatment 6 - 3,2 Bar; Treatment 7 - 3,4 Bar; Treatment 8 - 3,6 Bar; Treatment 9 - 3,8 Bar; Treatment 10 - 4,0 Bar.
Each patient will also receive kinesiotherapy treatment that will consist of:
- eight-minute massage of posterior lower leg muscles
- plantar aponeurosis stretching
Skanlab 25 BODYWAVEDevice
Also called produced by SKANLAB AS
Electric field diathermy therapy - Capacitive energy transfer system (CETS)
Time of each treatment (from 1 to 15) is eight minutes. Variable is the energy:
Treatment 1 - 3; Treatment 2 - 3; Treatment 3 - 4; Treatment 4 - 4; Treatment 5 - 5; Treatment 6 - 5; Treatment 7 - 6; Treatment 8 - 6; Treatment 9 - 7; Treatment 10 - 7; Treatment 11 - 7; Treatment 12 - 7; Treatment 13 - 7; Treatment 14 - 7; Treatment 15 - 7.
Each patient will also receive kinesiotherapy treatment that will consist of:
- eight-minute massage of posterior lower leg muscles
- plantar aponeurosis stretching
EVO US13 CosmoGammaDevice
Also called produced by EMILDUE
Ultrasound therapy
Doses applied as following:
Each treatment (from 1 to 15) is pulsed ultrasound (1MHz, pulsed 1:4). Variable is the time and intensity:
Treatment 1 - 4 minutes, 0,4 W/cm2; Treatment 2 - 5 minutes, 0,4 W/cm2; Treatment 3 - 5 minutes, 0,5 W/cm2; Treatment 4 - 6 minutes, 0,5 W/cm2; Treatment 5 - 6 minutes, 0,6 W/cm2; Treatment 6 - 6 minutes, 0,6 W/cm2; Treatment 7 - 6 minutes, 0,6 W/cm2; Treatment 8 - 6 minutes, 0,7 W/cm2; Treatment 9 - 7 minutes, 0,7 W/cm2; Treatment 10 - 7 minutes, 0,7 W/cm2; Treatment 11 - 7 minutes, 0,8 W/cm2; Treatment 12 - 8 minutes, 0,8 W/cm2; Treatment 13 - 8 minutes, 0,8 W/cm2; Treatment 14 - 8 minutes, 0,8 W/cm2; Treatment 15 - 8 minutes, 0,8 W/cm2.
Each patient will also receive kinesiotherapy treatment that will consist of:
- eight-minute massage of posterior lower leg muscles
- plantar aponeurosis stretching
Sham LASER CTL1106MXDevice
Also called produced by CTL
Sham laser therapy Time of each treatment (from 1 to 15) is four to five minutes. Developed is 10 points, each point takes 15 seconds. Device is unplugged and it does not emit any radiation.The patient does not know that the procedure is not really executed.
Each patient will also receive kinesiotherapy treatment that will consist of:
- eight-minute massage of posterior lower leg muscles
- plantar aponeurosis stretching
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - ESWT Treatment | Active comparator | Patients treated with Extracorporeal Shock Wave Therapy once a week for 10 weeks Receives: Device: Shock Master 300 |
| Group 2 - Body Wave | Active comparator | Patients treated with electric field diathermy three times a week for 5 weeks Receives: Device: Skanlab 25 BODYWAVE |
| Group 3 - Ultrasound | Active comparator | Patients treated with ultrasound therapy three times a week for 5 weeks Receives: Device: EVO US13 CosmoGamma |
| Group 4 - Control group | Sham comparator | Patients treated with sham laser therapy three times a week for 5 weeks Receives: Device: Sham LASER CTL1106MX |
What is being measured
The primary outcome is the main question the study is designed to answer.
The American Orthopedic Foot and Ankle Society Score (AOFAS) - Change
The American Orthopedic Foot and Ankle Society Score (AOFAS) is one of most widely used clinician-reporting tools for foot and ankle conditions. Developed in 1994, it is a clinician-based score that measures outcomes for four different anatomic regions of the foot: The ankle-hindfoot, midfoot, metatarsophalangeal (MTP)-interphalangeal (IP) for the hallux, and MTP-IP for the lesser toes.
The four anatomic regions of the AOFAS are all represented by a different version of the survey with each tool designed to be used independently. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.
Measured: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The SF-36v2 Health Survey (SF-36v2) - Change
The SF-36v2 Health Survey is a multipurpose, short-form health survey with 36 questions that yields an eight-scale profile of functional health and well-being, as well as two psychometrically based physical and mental health summary measures and a preference-based health utility index. Like its predecessor, the SF-36 Health Survey , the SF-36v2 is a generic measure of health status, as opposed to one that targets a specific age, disease, or treatment group. It has proven useful for conducting surveys of general and specific populations, comparing the relative burden of diseases, and differentiating the health benefits produced by a wide range of treatments.
Measured: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The Laitinen Pain Indicator Questionnaire
The Laitinen Pain Indicator Questionnaire is subjective and point tool which is used to assess the level of pain. Patients have to evaluate four indicators: pain intensity, the frequency of pain, the frequency of use of analgesics and physical activity limitations. Each indicator score is assigned from 0 to 4, with 0 being no problem, and four being a maximum problem.
Measured: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
Secondary outcomes (3)
Two weights test
The two weights test is measures the uniformity of the load of the lower limbs. The patient gets the right lower limb on one scale and another limb on the other scale. By standing on the scales must look ahead. The range of measurement error is five kilograms.
Measured: Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
Heel standing test
The heel standing test is to measure the intensity of pain experienced by burdening calcaneus. The patient is standing by the wall and must stand on both heel bones at the same time, then turn on the right calcaneus and then on the left calcaneus. Each of the three above mentioned activities is assessed using a three-point scale, depending on the feasibility of the task by the patient: job done at 100-75% without much problem, the task done at 75-25% with difficulty, the task done at 25-0% with great difficulty, or not done at all.
The test was created for this study and a researcher authorship.
Measured: Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
The Visual Analogue Scale
The visual analogue scale is a measurement instrument that is used for subjective assessment of pain made by the patient. The pain can be evaluated in a ten-point scale, where one represents no pain and ten is the pain unbearable.
Measured: Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel SpurStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Kociuga, Medical University of Lodz
- Investigators
- Natalia Kociuga, master, Principal investigator, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934100
- Sponsor's protocol ID
- RNN/47/16/KE
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur
- ClinicalTrials.gov ID
- NCT02934100
- Acronym / sponsor ID
- RNN/47/16/KE
- Conditions
- Heel Spur, Calcaneal Spur
- Keywords
- Calcaneal spur, Heel spur, ESWT, Extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy, skanlab 25 bodywave, sham laser therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 14 Oct 2016 (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.
This study evaluates the effectiveness of physiotherapy and kinesiotherapy in patients with calcaneal spurs. the aim of the study is to compare the efficacy of calcaneal spurs treatment provided with extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy associated with kinesiotherapy and sham laser in combination with kinesiotherapy. In each group kinesiotherapy treatment is the same and consists of an eight-minute massage of posterior lower leg muscles and plantar aponeurosis stretching.
Detailed description
Number of 120 diagnosed with heel spur patients, will be allocated randomly into one of three treatment groups or into the control group. Assignment to a group is random, but before that happens patients will be questioned about inclusion and exclusion criteria of the study. Depending on group allocation, patients in treatment groups will receive one of the following physical therapy treatments:
- ESWT (once a week for 10 weeks)
- ultrasound (three times a week for 5 weeks)
- electric field diathermy (three times a week for 5 weeks).
Patients allocated in control group, will receive a sham laser therapy (only the timer on the machine activated) three times a week for 5 weeks.
Regardless of affiliation to the group, each patient will also receive kinesiotherapy treatment.
At the beginning of the study, each patient receives the "Information for the patient," describing the exact course of each stage of the study, then signs a "Form of informed consent to participate in the study.". The next stage of the study is to fill in the participant survey questionnaire and physical examination provided by the researcher.
Assessment of improvements will be made twice: right after the therapy and two months later. Every stage of the study is carried out by one and the same investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - ESWT Treatment | Active comparator | Device: Shock Master 300Patients treated with Extracorporeal Shock Wave Therapy once a week for 10 weeks |
| Group 2 - Body Wave | Active comparator | Device: Skanlab 25 BODYWAVEPatients treated with electric field diathermy three times a week for 5 weeks |
| Group 3 - Ultrasound | Active comparator | Device: EVO US13 CosmoGammaPatients treated with ultrasound therapy three times a week for 5 weeks |
| Group 4 - Control group | Sham comparator | Device: Sham LASER CTL1106MXPatients treated with sham laser therapy three times a week for 5 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- heel spur (calcaneal spur) diagnosed by a doctor based on X-ray examination, diagnostic ultrasonography or MR
- signed informed consent
- heel pain for at least one month
Key exclusion criteria (29 listed)
- pregnancy
- generalized acute infection (fever, cough, runny nose)
- local infection in the treated leg (wound, swelling)
- cancer
- injections of corticosteroids in the last six weeks
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 |
|---|---|---|
| Shock Master 300Also: produced by GYMNAExtracorporeal Shock Wave Therapy In all treatments (from 1 to 10) applied number of pulses is 4500 and the frequency is based on the patients feelings (from 8 to 12 Hz). Variable is the pressure: Treatment 1 - 2,5 Bar; Treatment 2 - 2,6 Bar; Treatment 3 - 2,7 Bar; Treatment 4 - 2,8 Bar; Treatment 5 - 3,0 Bar; Treatment 6 - 3,2 Bar; Treatment 7 - 3,4 Bar; Treatment 8 - 3,6 Bar; Treatment 9 - 3,8 Bar; Treatment 10 - 4,0 Bar. Each patient will also receive kinesiotherapy treatment that will consist of: * eight-minute massage of posterior lower leg muscles * plantar aponeurosis stretching | Device | Group 1 - ESWT Treatment |
| Skanlab 25 BODYWAVEAlso: produced by SKANLAB ASElectric field diathermy therapy - Capacitive energy transfer system (CETS) Time of each treatment (from 1 to 15) is eight minutes. Variable is the energy: Treatment 1 - 3; Treatment 2 - 3; Treatment 3 - 4; Treatment 4 - 4; Treatment 5 - 5; Treatment 6 - 5; Treatment 7 - 6; Treatment 8 - 6; Treatment 9 - 7; Treatment 10 - 7; Treatment 11 - 7; Treatment 12 - 7; Treatment 13 - 7; Treatment 14 - 7; Treatment 15 - 7. Each patient will also receive kinesiotherapy treatment that will consist of: * eight-minute massage of posterior lower leg muscles * plantar aponeurosis stretching | Device | Group 2 - Body Wave |
| EVO US13 CosmoGammaAlso: produced by EMILDUEUltrasound therapy Doses applied as following: Each treatment (from 1 to 15) is pulsed ultrasound (1MHz, pulsed 1:4). Variable is the time and intensity: Treatment 1 - 4 minutes, 0,4 W/cm2; Treatment 2 - 5 minutes, 0,4 W/cm2; Treatment 3 - 5 minutes, 0,5 W/cm2; Treatment 4 - 6 minutes, 0,5 W/cm2; Treatment 5 - 6 minutes, 0,6 W/cm2; Treatment 6 - 6 minutes, 0,6 W/cm2; Treatment 7 - 6 minutes, 0,6 W/cm2; Treatment 8 - 6 minutes, 0,7 W/cm2; Treatment 9 - 7 minutes, 0,7 W/cm2; Treatment 10 - 7 minutes, 0,7 W/cm2; Treatment 11 - 7 minutes, 0,8 W/cm2; Treatment 12 - 8 minutes, 0,8 W/cm2; Treatment 13 - 8 minutes, 0,8 W/cm2; Treatment 14 - 8 minutes, 0,8 W/cm2; Treatment 15 - 8 minutes, 0,8 W/cm2. Each patient will also receive kinesiotherapy treatment that will consist of: * eight-minute massage of posterior lower leg muscles * plantar aponeurosis stretching | Device | Group 3 - Ultrasound |
| Sham LASER CTL1106MXAlso: produced by CTLSham laser therapy Time of each treatment (from 1 to 15) is four to five minutes. Developed is 10 points, each point takes 15 seconds. Device is unplugged and it does not emit any radiation.The patient does not know that the procedure is not really executed. Each patient will also receive kinesiotherapy treatment that will consist of: * eight-minute massage of posterior lower leg muscles * plantar aponeurosis stretching | Device | Group 4 - Control group |
Primary outcome
The American Orthopedic Foot and Ankle Society Score (AOFAS) - Change
Time frame: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The American Orthopedic Foot and Ankle Society Score (AOFAS) is one of most widely used clinician-reporting tools for foot and ankle conditions. Developed in 1994, it is a clinician-based score that measures outcomes for four different anatomic regions of the foot: The ankle-hindfoot, midfoot, metatarsophalangeal (MTP)-interphalangeal (IP) for the hallux, and MTP-IP for the lesser toes. The four anatomic regions of the AOFAS are all represented by a different version of the survey with each tool designed to be used independently. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.
The SF-36v2 Health Survey (SF-36v2) - Change
Time frame: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The SF-36v2 Health Survey is a multipurpose, short-form health survey with 36 questions that yields an eight-scale profile of functional health and well-being, as well as two psychometrically based physical and mental health summary measures and a preference-based health utility index. Like its predecessor, the SF-36 Health Survey , the SF-36v2 is a generic measure of health status, as opposed to one that targets a specific age, disease, or treatment group. It has proven useful for conducting surveys of general and specific populations, comparing the relative burden of diseases, and differentiating the health benefits produced by a wide range of treatments.
The Laitinen Pain Indicator Questionnaire
Time frame: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The Laitinen Pain Indicator Questionnaire is subjective and point tool which is used to assess the level of pain. Patients have to evaluate four indicators: pain intensity, the frequency of pain, the frequency of use of analgesics and physical activity limitations. Each indicator score is assigned from 0 to 4, with 0 being no problem, and four being a maximum problem.
3 secondary outcomes
Two weights test
Time frame: Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
Heel standing test
Time frame: Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
The Visual Analogue Scale
Time frame: Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- review article describing what the "heel spurs" really are and what are their consequencesLink provided by the sponsor.
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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.
Natalia Kociuga, master principal investigator
Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shock Master 300, Skanlab 25 BODYWAVE and EVO US13 CosmoGamma in people with Heel Spur and Calcaneal Spur, run by Medical University of Lodz at 1 site in Poland.
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 3 inclusion and 29 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 14 Oct 2016. 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 Poland. 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. Some participants in this study may receive a placebo. 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 Natalia Kociuga, master (+48609018609, nkociuga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The American Orthopedic Foot and Ankle Society Score (AOFAS) - Change (time frame: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.). The study lists 3 primary outcomes in all. 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 14 Oct 2016.