Foam RollerNCT05801302
Effects of Foam Rolling on the Plantar Flexors' Properties
A study testing Foam rolling (shorter volume) and Foam rolling (longer volume) in people with Foam Roller and Achilles Tendon, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
Self-massage is a set of therapeutic techniques performed by the individual using instruments such as a foam roller (i.e., foam rolling [FR]). This technique has been used in rehabilitation to recover myofascial dysfunctions and in physical/sports training, to improve performance in functional and sports activities. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Foam Roller, Achilles Tendon
- What is being tested?
- Foam rolling (shorter volume) and Foam rolling (longer volume)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2023to 3 Jun 2023
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female;
- Age between 18 and 35 years;
- Not involved in strength training for lower limbs;
- Not using foam rolling regularly;
- Only women using hormonal contraceptive pills will be included in order to standardize the hormonal cycle.
Who cannot join
- History in the last year of musculoskeletal injuries in the lower limbs that represent a contraindication for the execution of maximum exercises or that may interfere with performance during evaluations and treatment sessions (Achilles tendinopathy, ligament ruptures with or without surgical procedures, recent cases of muscle injury or sprain of ankle);
- Presenting with inflammation, acute pain or delayed muscle pain on the day of assessment;
- Performing some type of high-intensity physical activity for up to 72 hours before assessments;
- Ingestion of some type of analgesic medication, alcohol or caffeine in the last 48 hours before the evaluations;
- Have respiratory or cardiovascular conditions considered a risk factor or limiting to maximum tests;
- Use of anabolic steroid supplements.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: Acute Effects of Different Foam Rolling Protocols on the Plantar Flexors' Musculotendinous Properties in Healthy Individuals
Self-massage is a set of therapeutic techniques performed by the individual using instruments such as a foam roller (i.e., foam rolling [FR]). This technique has been used in rehabilitation to recover myofascial dysfunctions and in physical/sports training, to improve performance in functional and sports activities. Possible changes in the muscle's and tendon's mechanical properties may help to explain the FR effects, however, the dose-response relationship is not clear acutely. Furthermore, body composition also seems to influence the pressure applied to the different tissues during FR, since it can attenuate the forces applied on the tissues. Therefore, the aim of this study is to verify the acute effects of different FR volumes on the plantar flexors' musculotendinous properties in healthy individuals. Twenty healthy subjects (male and female) aged between 18-35 years will perform three different FR conditions: FR90 (3x30s), FR180 (3x60s), and a control condition (CTRL; without the application of any intervention) with a seven-day wash-out period. The Achilles tendon morphological, mechanical, and material properties, medial gastrocnemius passive muscular stiffness, plantar flexors' muscle architecture, and the adipose tissue's thickness, skin temperature and the jump height (assessed during the unilateral countermovement jump) will be obtained. Assessments will be carried out before and immediately after the FR application in the different conditions. Descriptive statistics (mean, standard deviation, and standard error) will be used to present the results. The normality and sphericity of the data will be evaluated using the Shapiro-Wilk and Mauchly tests, respectively. A two-way ANOVA (condition [FR90, FR180, and CTRL] and moments [pre- and post-intervention]) will be used to compare the results. A post-hoc Bonferroni test will be used to find possible differences. A Pearson product-moment correlation test (parametric data) or a Spearman correlation test (non-parametric data) will be used to verify the association between the adipose tissue's thickness and the evaluated parameters. The effect size (Cohen's d) of each condition will be obtained. Responsiveness to conditions (FR90, FR180, and CTRL) will be determined using the typical error.
Read the detailed description
Self-massage is a set of therapeutic technique performed by the individual using instruments such as a foam roller (i.e., foam rolling [FR]). This technique has been used in rehabilitation to recover myofascial dysfunctions and in physical/sports training, to improve performance in functional and sports activities. Possible changes in the muscle's and tendon's mechanical properties may help to explain the FR effects. Although some studies have found a decreased muscle stiffness after FR intervention, other studies have reported no changes in muscle stiffness. Furthermore, a single study investigated the FR effects on the tendon and found no stiffness changes post-intervention. The between-studies methodological procedures heterogeneity, especially the different FR protocols (e.g., pressure-volume) may partially justify conflicting results. However, the dose-response relationship is not clear acutely. Furthermore, body composition also seems to influence the pressure applied to the different tissues during FR. Therefore, the aim of this study is to verify the acute effects of different FR volumes on the plantar flexors' musculotendinous properties in healthy individuals. Twenty healthy subjects (male and female) aged between 18-35 years will perform three different FR conditions: FR90 (3x30s), FR180 (3x60s), and a control condition (CTRL; without the application of any intervention) with a seven-day wash-out period. The weight-bearing during the FR application will be obtained through ground reaction forces, measured through force platform. The Achilles tendon morphological properties (length and cross-sectional area) will be evaluated using ultrasonography. In order to evaluate the mechanical (stiffness, force, and elongation) and material (Young's modulus, stress, and strain) properties, three maximum voluntary isometric contractions (MVIC) will be performed in a plantar flexion ramp in the isokinetic dynamometer with ultrasonography. The tendon force will be corrected by the tibialis anterior coactivation and adjusted by the tendon displacement caused by joint rotation during MVIC. The tendon elongation will be monitored during CMVIC using the ultrasound. The medial gastrocnemius muscle stiffness will be calculated by the variation in a passive dorsiflexion torque (isokinetic dynamometer) and the variation in the muscle length (ultrasound). The adipose tissue's thickness also will be obtained from ultrasound. The skin temperature will be evaluated by a thermographic camera to investigate possible post-intervention changes. The unilateral countermovement jump performance will be evaluated by 2D kinematic data measurements, using a video camera. Assessments will be carried out before and immediately after the FR application in the different conditions. Descriptive statistics (mean, standard deviation, and standard error) will be used to present the results. The normality and sphericity of the data will be evaluated using the Shapiro-Wilk and Mauchly tests, respectively. A two-way ANOVA (condition [FR90, FR180, and CTRL] and moments [pre- and post-intervention]) will be used to compare the results. A post-hoc Bonferroni test will be used to localize possible differences. A Pearson product-moment correlation test (parametric data) or a Spearman correlation test (non-parametric data) will be used to verify the association between the adipose tissue's thickness on the evaluated parameters, classified as none (0.0), weak (0.1-0.3), moderate (0.4-0.6), strong (0.7-0.9), or perfect (1.0). The effect size (Cohen's d) of each condition will be obtained, classified as small effect size (< 0.20); moderate effect size (0.20-0.50); or large effect size (>0.80). Responsiveness to conditions (FR90, FR180, and CTRL) will be determined using the typical error.
- Conditions
- Foam Roller, Achilles Tendon
- Being tested
- Foam rolling (shorter volume), Foam rolling (longer volume)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam rolling (shorter volume)Device
A single intervention will be performed (3 sets of 30 seconds, with between-sets intervals of 30 seconds).
Foam rolling (longer volume)Device
A single intervention will be performed (3 sets of 60 seconds, with between-sets intervals of 30 seconds).
| Study group | Role | What they receive |
|---|---|---|
| Foam rolling (longer volume) | Experimental | Participants will perform a single session with a longer foam rolling volume. The protocol will be 3 sets of 60 seconds, with between-sets intervals of 30 seconds and a standardized command to the participant to perform the highest pressure possible. The speed will be controlled through metronome (30 bpm). The foam rolling will be performed with the foam roller placed under the plantar flexors and Achilles tendon in a sitting position, with hands supported to the ground, keeping the body out of contact with the ground, with the unassessed leg crossed above the leg of interest. A standard device (smooth foam roller) with dimensions of 30 cm x 15 cm will be used. Receives: Device: Foam rolling (longer volume) |
| Foam rolling (shorter volume) | Active comparator | Participants will perform a single session with a shorter foam rolling volume. The protocol will be 3 sets of 30 seconds, with between-sets intervals of 30 seconds and a standardized command to the participant to perform the highest pressure possible. The speed will be controlled through metronome (30 bpm). The foam rolling will be performed with the foam roller placed under the plantar flexors and Achilles tendon in a sitting position, with hands supported to the ground, keeping the body out of contact with the ground, with the unassessed leg crossed above the leg of interest. A standard device (smooth foam roller) with dimensions of 30 cm x 15 cm will be used. Receives: Device: Foam rolling (shorter volume) |
| Control condition | No intervention | Participants will remain in the intervention position (in a sitting position, with hands supported to the ground, with the unassessed leg crossed above the leg of interest) for 180 seconds (longer volume time), without the application of any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Achilles tendon stiffness
Tendon stiffness will be obtained by calculating the slope in the last 10% of the linear region of the force-deformation curve.
Measured: Change from baseline at immediately after intervention
Changes in medial gastrocnemius passive muscular stiffness
The medial gastrocnemius stiffness will be calculated by the variation in passive torque (dorsiflexion) divided by the variation in muscle length (assessed by ultrasound).
Measured: Change from baseline at immediately after intervention
Changes in unilateral countermovement jump height
The unilateral countermovement jump height will be measured using video camera and Tracker software.
Measured: Change from baseline at immediately after intervention
Secondary outcomes (5)
Changes in tendon Young's modulus
Tendon elastic modulus (Young's modulus) will be obtained by calculating the slope in the last 10% of the linear region of the stress-strain curve.
Measured: Change from baseline at immediately after intervention
Changes in Achilles tendon cross-sectional area
To obtain the Achilles tendon cross-sectional area (CSA), the ultrasound probe will be placed perpendicular to the tendon (in the transverse plane), and 3 images will be obtained with reference to the distances of 2, 4, 6, 8 and 10 cm of the muscle insertion in the calcaneus bone. Area values will be obtained for each image, and the final value of the area will be calculated by the average of these five values.
Measured: Change from baseline at immediately after intervention
Changes in Achilles tendon length
To obtain Achilles tendon length, the ultrasound probe will be placed longitudinally to the tendon (in the sagittal plane). The most distal portion of the Achilles tendon, inserted into the calcaneus bone, will be determined by ultrasound, and the respective point will be marked on the skin. After this, the probe will be moved to a proximal position until the visualization of the medial gastrocnemius myotendinous junction (MTJ), which is also marked on the skin. The distance between the two marked points on the skin will be measured with a measuring tape, this distance being considered representative of the tendon length.
Measured: Change from baseline at immediately after intervention
Changes in muscle Architecture
Muscular architecture will be evaluated with an ultrasound. Muscle architecture parameters will involve fascicle length, pennation angle, muscle thickness, and the adipose tissue's thickness. The images will be obtained with the subjects in the ventral decubitus position on a stretcher, with the knees extended and the ankle in neutral position (heel line at a 90° angle with respect to the longitudinal axis of the leg, 0° of plantarflexion). A custom system will be used to secure the ankle in the neutral position. The probe will be positioned longitudinally to the muscle fibers at 30% proximal for medial and lateral gastrocnemius, and 50% for soleus, of the distance between the popliteal fold and the lateral malleolus center.
Measured: Change from baseline at immediately after intervention
Changes in skin temperature
The skin temperature (plantar flexors and Achilles tendon region) will be evaluated using a thermographic camera.
Measured: Change from baseline at immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Mar 2023
- Primary completion20 May 2023
- Study completion3 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foam RollerStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeam Marcel Geremia, Federal University of Rio Grande do Sul
- Investigators
- Jeam Geremia, Dr, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801302
- Sponsor's protocol ID
- 4436122
- Status last verified
- May 2024
- First submitted
- 10 Mar 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Different Foam Rolling Protocols on the Plantar Flexors' Musculotendinous Properties in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05801302
- Acronym / sponsor ID
- 4436122
- Conditions
- Foam Roller, Achilles Tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 3 Jun 2023 (actual)
- First posted
- 6 Apr 2023 (actual)
- 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.
Self-massage is a set of therapeutic techniques performed by the individual using instruments such as a foam roller (i.e., foam rolling [FR]). This technique has been used in rehabilitation to recover myofascial dysfunctions and in physical/sports training, to improve performance in functional and sports activities. Possible changes in the muscle's and tendon's mechanical properties may help to explain the FR effects, however, the dose-response relationship is not clear acutely. Furthermore, body composition also seems to influence the pressure applied to the different tissues during FR, since it can attenuate the forces applied on the tissues. Therefore, the aim of this study is to verify the acute effects of different FR volumes on the plantar flexors' musculotendinous properties in healthy individuals. Twenty healthy subjects (male and female) aged between 18-35 years will perform three different FR conditions: FR90 (3x30s), FR180 (3x60s), and a control condition (CTRL; without the application of any intervention) with a seven-day wash-out period. The Achilles tendon morphological, mechanical, and material properties, medial gastrocnemius passive muscular stiffness, plantar flexors' muscle architecture, and the adipose tissue's thickness, skin temperature and the jump height (assessed during the unilateral countermovement jump) will be obtained. Assessments will be carried out before and immediately after the FR application in the different conditions. Descriptive statistics (mean, standard deviation, and standard error) will be used to present the results. The normality and sphericity of the data will be evaluated using the Shapiro-Wilk and Mauchly tests, respectively. A two-way ANOVA (condition [FR90, FR180, and CTRL] and moments [pre- and post-intervention]) will be used to compare the results. A post-hoc Bonferroni test will be used to find possible differences. A Pearson product-moment correlation test (parametric data) or a Spearman correlation test (non-parametric data) will be used to verify the association between the adipose tissue's thickness and the evaluated parameters. The effect size (Cohen's d) of each condition will be obtained. Responsiveness to conditions (FR90, FR180, and CTRL) will be determined using the typical error.
Detailed description
Self-massage is a set of therapeutic technique performed by the individual using instruments such as a foam roller (i.e., foam rolling [FR]). This technique has been used in rehabilitation to recover myofascial dysfunctions and in physical/sports training, to improve performance in functional and sports activities. Possible changes in the muscle's and tendon's mechanical properties may help to explain the FR effects. Although some studies have found a decreased muscle stiffness after FR intervention, other studies have reported no changes in muscle stiffness. Furthermore, a single study investigated the FR effects on the tendon and found no stiffness changes post-intervention. The between-studies methodological procedures heterogeneity, especially the different FR protocols (e.g., pressure-volume) may partially justify conflicting results. However, the dose-response relationship is not clear acutely. Furthermore, body composition also seems to influence the pressure applied to the different tissues during FR. Therefore, the aim of this study is to verify the acute effects of different FR volumes on the plantar flexors' musculotendinous properties in healthy individuals. Twenty healthy subjects (male and female) aged between 18-35 years will perform three different FR conditions: FR90 (3x30s), FR180 (3x60s), and a control condition (CTRL; without the application of any intervention) with a seven-day wash-out period. The weight-bearing during the FR application will be obtained through ground reaction forces, measured through force platform. The Achilles tendon morphological properties (length and cross-sectional area) will be evaluated using ultrasonography. In order to evaluate the mechanical (stiffness, force, and elongation) and material (Young's modulus, stress, and strain) properties, three maximum voluntary isometric contractions (MVIC) will be performed in a plantar flexion ramp in the isokinetic dynamometer with ultrasonography. The tendon force will be corrected by the tibialis anterior coactivation and adjusted by the tendon displacement caused by joint rotation during MVIC. The tendon elongation will be monitored during CMVIC using the ultrasound. The medial gastrocnemius muscle stiffness will be calculated by the variation in a passive dorsiflexion torque (isokinetic dynamometer) and the variation in the muscle length (ultrasound). The adipose tissue's thickness also will be obtained from ultrasound. The skin temperature will be evaluated by a thermographic camera to investigate possible post-intervention changes. The unilateral countermovement jump performance will be evaluated by 2D kinematic data measurements, using a video camera. Assessments will be carried out before and immediately after the FR application in the different conditions. Descriptive statistics (mean, standard deviation, and standard error) will be used to present the results. The normality and sphericity of the data will be evaluated using the Shapiro-Wilk and Mauchly tests, respectively. A two-way ANOVA (condition [FR90, FR180, and CTRL] and moments [pre- and post-intervention]) will be used to compare the results. A post-hoc Bonferroni test will be used to localize possible differences. A Pearson product-moment correlation test (parametric data) or a Spearman correlation test (non-parametric data) will be used to verify the association between the adipose tissue's thickness on the evaluated parameters, classified as none (0.0), weak (0.1-0.3), moderate (0.4-0.6), strong (0.7-0.9), or perfect (1.0). The effect size (Cohen's d) of each condition will be obtained, classified as small effect size (< 0.20); moderate effect size (0.20-0.50); or large effect size (>0.80). Responsiveness to conditions (FR90, FR180, and CTRL) will be determined using the typical error.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foam rolling (longer volume) | Experimental | Device: Foam rolling (longer volume)Participants will perform a single session with a longer foam rolling volume. The protocol will be 3 sets of 60 seconds, with between-sets intervals of 30 seconds and a standardized command to the participant to perform the highest pressure possible. The speed will be controlled through metronome (30 bpm). The foam rolling will be performed with the foam roller placed under the plantar flexors and Achilles tendon in a sitting position, with hands supported to the ground, keeping the body out of contact with the ground, with the unassessed leg crossed above the leg of interest. A standard device (smooth foam roller) with dimensions of 30 cm x 15 cm will be used. |
| Foam rolling (shorter volume) | Active comparator | Device: Foam rolling (shorter volume)Participants will perform a single session with a shorter foam rolling volume. The protocol will be 3 sets of 30 seconds, with between-sets intervals of 30 seconds and a standardized command to the participant to perform the highest pressure possible. The speed will be controlled through metronome (30 bpm). The foam rolling will be performed with the foam roller placed under the plantar flexors and Achilles tendon in a sitting position, with hands supported to the ground, keeping the body out of contact with the ground, with the unassessed leg crossed above the leg of interest. A standard device (smooth foam roller) with dimensions of 30 cm x 15 cm will be used. |
| Control condition | No intervention | –Participants will remain in the intervention position (in a sitting position, with hands supported to the ground, with the unassessed leg crossed above the leg of interest) for 180 seconds (longer volume time), without the application of any intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both male and female;
- Age between 18 and 35 years;
- Not involved in strength training for lower limbs;
- Not using foam rolling regularly;
- Only women using hormonal contraceptive pills will be included in order to standardize the hormonal cycle.
Key exclusion criteria (6 listed)
- History in the last year of musculoskeletal injuries in the lower limbs that represent a contraindication for the execution of maximum exercises or that may interfere with performance during evaluations and treatment sessions (Achilles tendinopathy, ligament ruptures with or without surgical procedures, recent cases of muscle injury or sprain of ankle);
- Presenting with inflammation, acute pain or delayed muscle pain on the day of assessment;
- Performing some type of high-intensity physical activity for up to 72 hours before assessments;
- Ingestion of some type of analgesic medication, alcohol or caffeine in the last 48 hours before the evaluations;
- Have respiratory or cardiovascular conditions considered a risk factor or limiting to maximum tests;
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 |
|---|---|---|
| Foam rolling (shorter volume)A single intervention will be performed (3 sets of 30 seconds, with between-sets intervals of 30 seconds). | Device | Foam rolling (shorter volume) |
| Foam rolling (longer volume)A single intervention will be performed (3 sets of 60 seconds, with between-sets intervals of 30 seconds). | Device | Foam rolling (longer volume) |
Primary outcome
Changes in Achilles tendon stiffness
Time frame: Change from baseline at immediately after intervention
Tendon stiffness will be obtained by calculating the slope in the last 10% of the linear region of the force-deformation curve.
Changes in medial gastrocnemius passive muscular stiffness
Time frame: Change from baseline at immediately after intervention
The medial gastrocnemius stiffness will be calculated by the variation in passive torque (dorsiflexion) divided by the variation in muscle length (assessed by ultrasound).
Changes in unilateral countermovement jump height
Time frame: Change from baseline at immediately after intervention
The unilateral countermovement jump height will be measured using video camera and Tracker software.
5 secondary outcomes
Changes in tendon Young's modulus
Time frame: Change from baseline at immediately after intervention
Changes in Achilles tendon cross-sectional area
Time frame: Change from baseline at immediately after intervention
Changes in Achilles tendon length
Time frame: Change from baseline at immediately after intervention
Changes in muscle Architecture
Time frame: Change from baseline at immediately after intervention
Changes in skin temperature
Time frame: Change from baseline at immediately after intervention
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 16 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Foam Roller
Recruiting
Effect of Foam Rolling After Total Knee Arthroplasty
Total Knee Arthroplasty Recovery, Total Knee Arthroplasty Postoperative Pain
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.
Jeam Geremia, Dr study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam rolling (shorter volume) and Foam rolling (longer volume) in people with Foam Roller and Achilles Tendon, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 5 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 16 May 2024. 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 Brazil. 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?
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?
Changes in Achilles tendon stiffness (time frame: Change from baseline at immediately after intervention). 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 16 May 2024.