Plantar FasciaNCT07103226
Analysis of Hyperthermia as an Adjunctive Treatment to Evidence-based Clinical Intervention in Subjects With Plantar Fasciitis: a Double-blind Randomized Clinical Trial
A study testing Hyperthermia, Physical Exercise and Stretching in people with Plantar Fascia and Hyperthermia, run by University of Malaga.
Trial summary
This project aims to analyze the use of hyperthermia within a treatment protocol for plantar fasciitis, as well as to determine the difference between two and three sessions per week. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fascia, Hyperthermia
- What is being tested?
- Hyperthermia, Physical Exercise and Stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a diagnosis confirmed by performing an ultrasonography of Plantar Fascitis
- Have not yet received physiotherapy treatment.
Who cannot join
- Have undergone surgery.
- Those who refuse to participate in this study.
- Patients with muscle atrophy due to plantar fasciitis.
- Medical conditions that are contraindications for hyperthermia therapy.
About this study
This project aims to analyze the use of hyperthermia within a treatment protocol for plantar fasciitis, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the foot muscles and stretching the plantar fascia and posterior chain, hyperthermia on the plantar fascia insertion area in the calcaneus and adjacent areas, and the use of an orthotic insole used for walking. The third and fourth intervention groups will receive the same treatment as mentioned above, but without hyperthermia. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure local pain using an algometer, assess ankle joint range of motion, and use ultrasound imaging techniques. Subjective variables will also be used through validated questionnaires, which will address physical activity, perceived functional limitations in patients with lower limb pathologies, lower limb functional assessment, and a visual analogue scale for pain perception.
- Conditions
- Plantar Fascia, Hyperthermia
- Being tested
- Hyperthermia, Physical Exercise, Stretching, Orthopedic insole
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaRadiation
Hyperthermia will be applied for a period of 15 to 20 minutes in the area to be treated, maintaining a thermal sensation of gentle heat for the patient and accompanied by active-assisted or passive mobilization of the structures adjacent to the plantar fascia.
Physical ExerciseOther
The therapeutic physical exercise focused on the flexor muscles of the foot will consist of 3 periods of isometric contraction of 15 seconds, with a rest period of 30 seconds, varying the number of repetitions from 3 to 5 depending on the patient's symptoms.
StretchingOther
The plantar fascia stretch will be performed with the patient in the supine position. Maximum dorsiflexion will be achieved, and the lower limb will be elevated with the knee extended as tolerated. This procedure will be performed three times in a row for 30 seconds, with a 1-minute rest between each stretch.
Orthopedic insoleOther
Imposition of an orthopedic insole
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia 2 times per week | Experimental | Not described Receives: Radiation: Hyperthermia; Other: Physical Exercise; Other: Stretching; Other: Orthopedic insole |
| Hyperthermia 3 times per week | Experimental | Not described Receives: Radiation: Hyperthermia; Other: Physical Exercise; Other: Stretching; Other: Orthopedic insole |
| Non-hyperthermia 2 times per week | Experimental | Not described Receives: Other: Physical Exercise; Other: Stretching; Other: Orthopedic insole |
| Non-hyperthermia 3 times per week | Experimental | Not described Receives: Other: Physical Exercise; Other: Stretching; Other: Orthopedic insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
FOOT AND ANKLE ABILITY MEASURE (FAAM)
This instrument is based on the subjective assessment of physical function and activities of daily living in patients with musculoskeletal disorders of the lower limb. It consists of 29 items, divided into two subscales: activities of daily living (21 items) and sports activities (8 items). Each question can be scored on a scale from 4 (no difficulty) to 0 (total inability to perform the activity in question). The maximum score is 84 for the activities of daily living subscale and 32 for sports activities, representing full functionality. The Spanish version has been shown to be correctly translated from its original version and to present a correct structure, internal consistency, reliability, correlation between the total items and between items, and validity.
Measured: Baseline and up to one year
LOWER EXTREMITY FUNCTIONAL SCALE (LEFS)
This questionnaire assesses perceived functionality in patients with a musculoskeletal problem in the lower limb. It consists of 20 questions, each of which is scored by the patient, ranging from 0 (extreme difficulty or inability to perform the activity) to 4 (no difficulty). The maximum score is 80 (no functional limitations), and the minimum score of 0 indicates extreme limitation. The Spanish adaptation has demonstrated similar values to the English version in the areas of internal consistency, reliability, structure, and error.
Measured: Baseline and up to one year
International Physical Activity Questionnaire (IPAQ)
This instrument is designed to measure physical activity levels in an adult population and can serve as a reference for making recommendations regarding physical activity. It comes in two versions: the long version with 31 items (IPAQ-LF) and the short version with 9 items (IPAQ-SF). The short version, which will be used in this study as recommended by the authors, measures activity at four intensity levels, ranging from 1 (vigorous-intensity activity) to 4 (sedentary). It has very good reliability (r=0.8).
Measured: Baseline and up to one year
Visual Analogue Scale (VAS)
It consists of an 11-point numerical scale, ranging from 0 (no pain) to 10 (maximum pain intensity), which serves as a quantification for measuring pain intensity. It has moderate to good reliability.
Measured: Baseline and up to one year
PRESSURE PAIN THRESHOLD (PPT)
Pressure Pain Threshold (PPT) has proven to be a reliable method for measuring pain intensity in patients with plantar fasciitis. To perform this test, the patient is placed prone, and the most painful point under the heel is palpated. Once located, a portable mechanical pressure algometer is used, increasing pressure at a rate of 30 kPa/s. The patient is provided with a portable switch that they can activate when the session changes from pressure to pain. This procedure is repeated three times, with a 30-second rest period between tests.
Measured: Baseline and up to one year
WEIGHT-BEARING LUNGE TEST (WBLT)
The Weight-Bearing Lunge Test (WBLT) is a reliable method for measuring ankle joint range of motion by measuring the maximum anterior displacement of the tibia on the talus in a weight-bearing position. The patient stands facing a wall with their fingers on the wall for balance and the healthy limb 30 centimeters behind the affected limb. The affected foot is placed parallel to a tape measure with the knee perpendicular to the wall, with the foot remaining in full contact with the floor. The patient is asked to touch the wall with their knee, without lifting their heel from the floor, doing this four times: the first attempt is to measure the distance from the wall, and the remaining three are used as measurements, with the average being recorded.
Measured: Baseline and up to one year
Ultrasonography
Ultrasound imaging is an excellent noninvasive method for analyzing foot structures, including the plantar fascia. To do this, the patient is placed prone, and the transducer is positioned on the plantar surface of the heel, pointing toward the second toe, to assess the insertion of the plantar fascia into the medial tuberosity of the calcaneus. Subsequently, using the ultrasound software, three successive measurements of plantar fascia thickness are taken, first on the symptomatic foot and then on the contralateral foot. This measurement has proven to be a reliable method for assessing the plantar fascia.
Measured: Baseline and up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Manuel González-Sánchez, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103226
- Sponsor's protocol ID
- 139/2025
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Hyperthermia as an Adjunctive Treatment to Evidence-based Clinical Intervention in Subjects With Plantar Fasciitis: a Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07103226
- Acronym / sponsor ID
- 139/2025
- Conditions
- Plantar Fascia, Hyperthermia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Aug 2025 (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.
This project aims to analyze the use of hyperthermia within a treatment protocol for plantar fasciitis, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the foot muscles and stretching the plantar fascia and posterior chain, hyperthermia on the plantar fascia insertion area in the calcaneus and adjacent areas, and the use of an orthotic insole used for walking. The third and fourth intervention groups will receive the same treatment as mentioned above, but without hyperthermia. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure local pain using an algometer, assess ankle joint range of motion, and use ultrasound imaging techniques. Subjective variables will also be used through validated questionnaires, which will address physical activity, perceived functional limitations in patients with lower limb pathologies, lower limb functional assessment, and a visual analogue scale for pain perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia 2 times per week | Experimental | Radiation: Hyperthermia, Other: Physical Exercise, Other: Stretching, Other: Orthopedic insole |
| Hyperthermia 3 times per week | Experimental | Radiation: Hyperthermia, Other: Physical Exercise, Other: Stretching, Other: Orthopedic insole |
| Non-hyperthermia 2 times per week | Experimental | Other: Physical Exercise, Other: Stretching, Other: Orthopedic insole |
| Non-hyperthermia 3 times per week | Experimental | Other: Physical Exercise, Other: Stretching, Other: Orthopedic insole |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have a diagnosis confirmed by performing an ultrasonography of Plantar Fascitis
- Have not yet received physiotherapy treatment.
Key exclusion criteria (4 listed)
- Have undergone surgery.
- Those who refuse to participate in this study.
- Patients with muscle atrophy due to plantar fasciitis.
- Medical conditions that are contraindications for hyperthermia therapy.
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 |
|---|---|---|
| HyperthermiaHyperthermia will be applied for a period of 15 to 20 minutes in the area to be treated, maintaining a thermal sensation of gentle heat for the patient and accompanied by active-assisted or passive mobilization of the structures adjacent to the plantar fascia. | Radiation | Hyperthermia 2 times per week, Hyperthermia 3 times per week |
| Physical ExerciseThe therapeutic physical exercise focused on the flexor muscles of the foot will consist of 3 periods of isometric contraction of 15 seconds, with a rest period of 30 seconds, varying the number of repetitions from 3 to 5 depending on the patient's symptoms. | Other | Hyperthermia 2 times per week, Hyperthermia 3 times per week, Non-hyperthermia 2 times per week, Non-hyperthermia 3 times per week |
| StretchingThe plantar fascia stretch will be performed with the patient in the supine position. Maximum dorsiflexion will be achieved, and the lower limb will be elevated with the knee extended as tolerated. This procedure will be performed three times in a row for 30 seconds, with a 1-minute rest between each stretch. | Other | Hyperthermia 2 times per week, Hyperthermia 3 times per week, Non-hyperthermia 2 times per week, Non-hyperthermia 3 times per week |
| Orthopedic insoleImposition of an orthopedic insole | Other | Hyperthermia 2 times per week, Hyperthermia 3 times per week, Non-hyperthermia 2 times per week, Non-hyperthermia 3 times per week |
Primary outcome
FOOT AND ANKLE ABILITY MEASURE (FAAM)
Time frame: Baseline and up to one year
This instrument is based on the subjective assessment of physical function and activities of daily living in patients with musculoskeletal disorders of the lower limb. It consists of 29 items, divided into two subscales: activities of daily living (21 items) and sports activities (8 items). Each question can be scored on a scale from 4 (no difficulty) to 0 (total inability to perform the activity in question). The maximum score is 84 for the activities of daily living subscale and 32 for sports activities, representing full functionality. The Spanish version has been shown to be correctly translated from its original version and to present a correct structure, internal consistency, reliability, correlation between the total items and between items, and validity.
LOWER EXTREMITY FUNCTIONAL SCALE (LEFS)
Time frame: Baseline and up to one year
This questionnaire assesses perceived functionality in patients with a musculoskeletal problem in the lower limb. It consists of 20 questions, each of which is scored by the patient, ranging from 0 (extreme difficulty or inability to perform the activity) to 4 (no difficulty). The maximum score is 80 (no functional limitations), and the minimum score of 0 indicates extreme limitation. The Spanish adaptation has demonstrated similar values to the English version in the areas of internal consistency, reliability, structure, and error.
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline and up to one year
This instrument is designed to measure physical activity levels in an adult population and can serve as a reference for making recommendations regarding physical activity. It comes in two versions: the long version with 31 items (IPAQ-LF) and the short version with 9 items (IPAQ-SF). The short version, which will be used in this study as recommended by the authors, measures activity at four intensity levels, ranging from 1 (vigorous-intensity activity) to 4 (sedentary). It has very good reliability (r=0.8).
Visual Analogue Scale (VAS)
Time frame: Baseline and up to one year
It consists of an 11-point numerical scale, ranging from 0 (no pain) to 10 (maximum pain intensity), which serves as a quantification for measuring pain intensity. It has moderate to good reliability.
PRESSURE PAIN THRESHOLD (PPT)
Time frame: Baseline and up to one year
Pressure Pain Threshold (PPT) has proven to be a reliable method for measuring pain intensity in patients with plantar fasciitis. To perform this test, the patient is placed prone, and the most painful point under the heel is palpated. Once located, a portable mechanical pressure algometer is used, increasing pressure at a rate of 30 kPa/s. The patient is provided with a portable switch that they can activate when the session changes from pressure to pain. This procedure is repeated three times, with a 30-second rest period between tests.
WEIGHT-BEARING LUNGE TEST (WBLT)
Time frame: Baseline and up to one year
The Weight-Bearing Lunge Test (WBLT) is a reliable method for measuring ankle joint range of motion by measuring the maximum anterior displacement of the tibia on the talus in a weight-bearing position. The patient stands facing a wall with their fingers on the wall for balance and the healthy limb 30 centimeters behind the affected limb. The affected foot is placed parallel to a tape measure with the knee perpendicular to the wall, with the foot remaining in full contact with the floor. The patient is asked to touch the wall with their knee, without lifting their heel from the floor, doing this four times: the first attempt is to measure the distance from the wall, and the remaining three are used as measurements, with the average being recorded.
Ultrasonography
Time frame: Baseline and up to one year
Ultrasound imaging is an excellent noninvasive method for analyzing foot structures, including the plantar fascia. To do this, the patient is placed prone, and the transducer is positioned on the plantar surface of the heel, pointing toward the second toe, to assess the insertion of the plantar fascia into the medial tuberosity of the calcaneus. Subsequently, using the ultrasound software, three successive measurements of plantar fascia thickness are taken, first on the symptomatic foot and then on the contralateral foot. This measurement has proven to be a reliable method for assessing the plantar fascia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia, Physical Exercise and Stretching in people with Plantar Fascia and Hyperthermia, run by University of Malaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
FOOT AND ANKLE ABILITY MEASURE (FAAM) (time frame: Baseline and up to one year). The study lists 7 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 5 Aug 2025.