Fasciitis, PlantarNCT02467465
Efficacy of Dry Needling in Plantar Fasciitis
A study testing Physical therapy modalities and Invasive Physical therapy modalities in people with Fasciitis, Plantar, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The plantar fasciitis (PF) is the most common cause of pain on the underside of the heel. About 10% to 20% of the population suffer once during their lifetime. PF concept began to describe at the end of XX century through the discovery of new clinical and histopathological signs of the plantar fascia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- Physical therapy modalities and Invasive Physical therapy modalities
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ultrasonographic study in which a proximal thickened affected plantar fascia is observed -greater than or equal to 4 mm.
- Pain fell to the first steps in the morning.
- Pain with palpation at the insertion of the medial calcaneal tubercle, above 5, in a 10-point VAS.
- Pathology time evolution of greater than or equal to 4 weeks.
- Age of patients over 18 years.
- Acceptance by the patient to participate in the study, having signed the informed consent.
Who cannot join
- Presence of neoplastic disease.
- Presence of neurological, sensory, orthopedic and / or surgical alterations.
- The patient is already doing treatment of physical medicine and rehabilitation.
- Be subjected to antiplatelet drug therapy.
- Fear of needles (needle phobia).
- Difficulty for the patient to understand the instructions to be followed during the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Madrid, 28040
About this study
The plantar fasciitis (PF) is the most common cause of pain on the underside of the heel. About 10% to 20% of the population suffer once during their lifetime. PF concept began to describe at the end of XX century through the discovery of new clinical and histopathological signs of the plantar fascia. The difficulty of diagnosis, understanding and treatment of PF require us to develop new treatment avenues to improve the approach and the understanding of it. Dry needling (DN) as a treatment of myofascial pain syndrome (MPS) and myofascial trigger points (MTP) of muscle associated with the pathology, it may be a good treatment strategy, as demonstrated in the treatment of MPS in other body regions such as the neck, shoulder or the lumbar spine.
Read the detailed description
Hypothesis:
Add dry needling to a physiotherapy intervention, increases the efficacy of treatment for plantar fasciosis.
Objectives:
General:
Test the efficacy of DN in addition to physiotherapy treatment includes: manual therapy and home exercises; directed to normalize muscle tone and inhibit MTP of the gastrocnemius and soleus muscles, in a group of patients who have been diagnosed with PF.
The variables to measure the efficacy are:
Pain assessment in the affected heel, by visual analog scale (VAS). Ultrasonographic assessment of the thickness of the plantar fascia affected, in longitudinal view, compared with the contralateral.
Goniometric assessment of joint range of ankle dorsiflexion, compared with the contralateral.
Specific:
Analyze the efficacy of the combination of DN treatment with manual therapy and home exercise, in patients who have been diagnosed with PF through monitoring and comparison between groups.
Methodology:
Type of study: clinical trial.
Sample:
It has been used sample size calculator GRANMO version 7.12, and accepting an alpha risk of 0.05 and a beta risk of 0.2, 15 subjects were required in the first group and 15 in the second to detect a difference equal to or greater than 0.6 units. It is assumed that the common standard deviation is 0.57. It has been estimated loss rate of 0%.
population: patients with a confirmed diagnosis of PF, who agree to participate in the study after signing the informed consent and carry out the selection criteria.
Sample:
It has been used sample size calculator GRANMO version 7.12, and accepting an alpha risk of 0.05 and a beta risk of 0.2, 15 subjects were required in the first group and 15 in the second to detect a difference equal to or greater than 0.6 units. It is assumed that the common standard deviation is 0.57. It has been estimated loss rate of 0%.
Selection criteria:
Ultrasonographic study in which a proximal thickened affected plantar fascia is observed greater than or equal to 4 mm.
Pain fell to the first steps in the morning. Pain with palpation at the insertion of the medial calcaneal tubercle, above 5, in a 10-point VAS.
Pathology time evolution of greater than or equal to 4 weeks. Age of patients over 18 years. Acceptance by the patient to participate in the study, having signed the informed consent.
Absence of neoplastic disease. Absence of neurological, sensory, orthopedic and / or surgical alterations. The patient is already doing treatment of physical medicine and rehabilitation. Be subjected to antiplatelet drug therapy. Fear of needles (needle phobia). Difficulty for the patient to understand the instructions to be followed during the study.
Methods of collecting information:
Personal data for each patient and relevant to the study, collected in a protocolized questionnaire, as well as an Excel sheet. All this in a personal history, encoded according to a table of alphanumeric equivalents, allowing subsequent statistical analysis with SPSS19.0 program.
Statistical method:
Initially, a descriptive statistical analysis will be conducted: qualitative variables were summarized by frequency distribution and quantitative by its average and standard deviation. Also it summarizes the information graphically using box plots, bar charts and pie charts.
Furthermore an inferential analysis using parametric or non-parametric techniques, particularly for the main objective analysis of variance was used in two groups (assuming a normal distribution for the variable response) U test or Mann-Whitney will be made in the case lack of normal. To study the response variables in each test group the Student t test or unimuestral averages Wilcoxon signed ranks for related samples was used.
For the analysis of qualitative variables the test of Chi-square test and the association between quantitative variables will be analyzed using the Pearson correlation coefficients and Spearman.
To test these significant differences in values of p <0.05 was assumed. Statistical analysis was performed using the statistical software SPSS v19.0
- Conditions
- Fasciitis, Plantar
- Being tested
- Physical therapy modalities, Invasive Physical therapy modalities
- Keywords
- Fasciosis plantar, physiotherapy, fascitis plantar, dry needling
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy modalitiesOther
Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
Invasive Physical therapy modalitiesDevice
Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy modalities | Experimental | Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Receives: Other: Physical therapy modalities |
| Invasive Physical therapy modalities | Experimental | Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Receives: Other: Physical therapy modalities; Device: Invasive Physical therapy modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Measured: 1 day.
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Measured: 1 month
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Measured: 3 month
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Measured: 6 month
Secondary outcomes (16)
Pain Assessment in the Affected Heel, by Visual Analog Scale.
First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Measured: 1 day.
Pain Assessment in the Affected Heel, by Visual Analog Scale.
First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Measured: 1 month
Pain Assessment in the Affected Heel, by Visual Analog Scale.
First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Measured: 3 month
Pain Assessment in the Affected Heel, by Visual Analog Scale.
First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Measured: 6 month
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Measured: 1 day
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Measured: 1 month
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Measured: 3 month
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Measured: 6 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Measured: 1 day
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values.Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Measured: 1 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened.
Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Measured: 3 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Measured: 6 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Measured: 1 day
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Measured: 1 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Measured: 3 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startMay 2014
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fasciitis, PlantarStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Suárez Varela, Universidad Complutense de Madrid
- Investigators
- Suárez Miguel, Physician, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467465
- Sponsor's protocol ID
- Univ. Complutense de Madrid
- Status last verified
- Jul 2020
- First submitted
- 27 May 2015
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dry Needling in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT02467465
- Acronym / sponsor ID
- Univ. Complutense de Madrid
- Conditions
- Fasciitis, Plantar
- Keywords
- Fasciosis plantar, physiotherapy, fascitis plantar, dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The plantar fasciitis (PF) is the most common cause of pain on the underside of the heel. About 10% to 20% of the population suffer once during their lifetime. PF concept began to describe at the end of XX century through the discovery of new clinical and histopathological signs of the plantar fascia. The difficulty of diagnosis, understanding and treatment of PF require us to develop new treatment avenues to improve the approach and the understanding of it. Dry needling (DN) as a treatment of myofascial pain syndrome (MPS) and myofascial trigger points (MTP) of muscle associated with the pathology, it may be a good treatment strategy, as demonstrated in the treatment of MPS in other body regions such as the neck, shoulder or the lumbar spine.
Detailed description
Hypothesis:
Add dry needling to a physiotherapy intervention, increases the efficacy of treatment for plantar fasciosis.
Objectives:
General:
Test the efficacy of DN in addition to physiotherapy treatment includes: manual therapy and home exercises; directed to normalize muscle tone and inhibit MTP of the gastrocnemius and soleus muscles, in a group of patients who have been diagnosed with PF.
The variables to measure the efficacy are:
Pain assessment in the affected heel, by visual analog scale (VAS). Ultrasonographic assessment of the thickness of the plantar fascia affected, in longitudinal view, compared with the contralateral.
Goniometric assessment of joint range of ankle dorsiflexion, compared with the contralateral.
Specific:
Analyze the efficacy of the combination of DN treatment with manual therapy and home exercise, in patients who have been diagnosed with PF through monitoring and comparison between groups.
Methodology:
Type of study: clinical trial.
Sample:
It has been used sample size calculator GRANMO version 7.12, and accepting an alpha risk of 0.05 and a beta risk of 0.2, 15 subjects were required in the first group and 15 in the second to detect a difference equal to or greater than 0.6 units. It is assumed that the common standard deviation is 0.57. It has been estimated loss rate of 0%.
population: patients with a confirmed diagnosis of PF, who agree to participate in the study after signing the informed consent and carry out the selection criteria.
Sample:
It has been used sample size calculator GRANMO version 7.12, and accepting an alpha risk of 0.05 and a beta risk of 0.2, 15 subjects were required in the first group and 15 in the second to detect a difference equal to or greater than 0.6 units. It is assumed that the common standard deviation is 0.57. It has been estimated loss rate of 0%.
Selection criteria:
Ultrasonographic study in which a proximal thickened affected plantar fascia is observed greater than or equal to 4 mm.
Pain fell to the first steps in the morning. Pain with palpation at the insertion of the medial calcaneal tubercle, above 5, in a 10-point VAS.
Pathology time evolution of greater than or equal to 4 weeks. Age of patients over 18 years. Acceptance by the patient to participate in the study, having signed the informed consent.
Absence of neoplastic disease. Absence of neurological, sensory, orthopedic and / or surgical alterations. The patient is already doing treatment of physical medicine and rehabilitation. Be subjected to antiplatelet drug therapy. Fear of needles (needle phobia). Difficulty for the patient to understand the instructions to be followed during the study.
Methods of collecting information:
Personal data for each patient and relevant to the study, collected in a protocolized questionnaire, as well as an Excel sheet. All this in a personal history, encoded according to a table of alphanumeric equivalents, allowing subsequent statistical analysis with SPSS19.0 program.
Statistical method:
Initially, a descriptive statistical analysis will be conducted: qualitative variables were summarized by frequency distribution and quantitative by its average and standard deviation. Also it summarizes the information graphically using box plots, bar charts and pie charts.
Furthermore an inferential analysis using parametric or non-parametric techniques, particularly for the main objective analysis of variance was used in two groups (assuming a normal distribution for the variable response) U test or Mann-Whitney will be made in the case lack of normal. To study the response variables in each test group the Student t test or unimuestral averages Wilcoxon signed ranks for related samples was used.
For the analysis of qualitative variables the test of Chi-square test and the association between quantitative variables will be analyzed using the Pearson correlation coefficients and Spearman.
To test these significant differences in values of p <0.05 was assumed. Statistical analysis was performed using the statistical software SPSS v19.0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical therapy modalities | Experimental | Other: Physical therapy modalitiesManual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. |
| Invasive Physical therapy modalities | Experimental | Other: Physical therapy modalities, Device: Invasive Physical therapy modalitiesManual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ultrasonographic study in which a proximal thickened affected plantar fascia is observed -greater than or equal to 4 mm.
- Pain fell to the first steps in the morning.
- Pain with palpation at the insertion of the medial calcaneal tubercle, above 5, in a 10-point VAS.
- Pathology time evolution of greater than or equal to 4 weeks.
- Age of patients over 18 years.
Key exclusion criteria (6 listed)
- Presence of neoplastic disease.
- Presence of neurological, sensory, orthopedic and / or surgical alterations.
- The patient is already doing treatment of physical medicine and rehabilitation.
- Be subjected to antiplatelet drug therapy.
- Fear of needles (needle phobia).
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 |
|---|---|---|
| Physical therapy modalitiesMassage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. | Other | Invasive Physical therapy modalities, Physical therapy modalities |
| Invasive Physical therapy modalitiesDry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. | Device | Invasive Physical therapy modalities |
Primary outcome
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Time frame: 1 day.
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Time frame: 1 month
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Time frame: 3 month
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Time frame: 6 month
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
16 secondary outcomes
Pain Assessment in the Affected Heel, by Visual Analog Scale.
Time frame: 1 day.
Pain Assessment in the Affected Heel, by Visual Analog Scale.
Time frame: 1 month
Pain Assessment in the Affected Heel, by Visual Analog Scale.
Time frame: 3 month
Pain Assessment in the Affected Heel, by Visual Analog Scale.
Time frame: 6 month
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Time frame: 1 day
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Time frame: 1 month
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Time frame: 3 month
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Time frame: 6 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Time frame: 1 day
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Time frame: 1 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened.
Time frame: 3 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Time frame: 6 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Time frame: 1 day
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Time frame: 1 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Time frame: 3 month
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Suárez Miguel, Physician principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy modalities and Invasive Physical therapy modalities in people with Fasciitis, Plantar, run by Universidad Complutense de Madrid 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 6 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: finished, as of the sponsor's last update on 9 Sep 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View. (time frame: 1 day.). The study lists 4 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 9 Sep 2020.