BursitisNCT07099573
Analysis of Hyperthermia as an Adjunctive Treatment to Evidence-based Clinical Intervention in Subjects With Bursitis: a Double-blind Randomized Clinical Trial
A study testing Hyperthermia, Physical Exercise and Stretching in people with Bursitis and Hyperthermia, run by University of Malaga.
Trial summary
This project aims to analyze the use of hyperthermia within a bursitis treatment protocol, 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bursitis, 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
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Apr 2026
- 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 imaging test of Bursitis
- Have not yet received physiotherapy treatment.
Who cannot join
- Have undergone surgery.
- Those who refuse to participate in this study.
- Patients with muscle atrophy.
- Medical conditions that are contraindications for hyperthermia therapy.
About this study
This project aims to analyze the use of hyperthermia within a bursitis treatment protocol, 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 affected joint, stretching of the involved muscles, and the application of hyperthermia to the bursa and surrounding areas. 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: on the one hand, the objective variable will be measurement and assessment of the bursa using ultrasound imaging. Subjective measurement variables will also be used through validated questionnaires, which will address physical activity, perceived functional limitations, and the visual analog scale for pain perception.
- Conditions
- Bursitis, Hyperthermia
- Being tested
- Hyperthermia, Physical Exercise, Stretching
- Medical subject headings
- Bursitis, 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 bursa.
Physical ExerciseOther
The therapeutic physical exercise will consist of 3 periods of isometric contraction of 30 seconds, with a rest period of 1 minute, varying the number of repetitions from 3 to 5 depending on the patient's symptoms.
StretchingOther
Stretching of the involved muscles will involve 3 periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia 2 times per week | Experimental | Not described Receives: Radiation: Hyperthermia; Other: Physical Exercise; Other: Stretching |
| Hyperthermia 3 times per week | Experimental | Not described Receives: Radiation: Hyperthermia; Other: Physical Exercise; Other: Stretching |
| Non-Hyperthermia 2 times per week | Experimental | Not described Receives: Other: Physical Exercise; Other: Stretching |
| Non-Hyperthermia 3 times per week | Experimental | Not described Receives: Other: Physical Exercise; Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
DISABILITIES OF THE ARM, SHOULDER AND HAND QUESTIONNAIRE (DASH)
It consists of a self-administered questionnaire that assesses the upper limb as a functional unit and allows for the quantification and comparison of the impact of different processes affecting different regions of the limb. It consists of a core of 30 items and two optional modules, each with four items. Each item is scored from 1 to 5, with higher scores corresponding to greater symptom intensity. The final score can range from 30 to 150 points, with a scale of 0 (best possible score) to 100 (worst possible score). The optional modules are scored separately. The Spanish version has very high reliability (r=0.96).
Measured: Baseline and up to one year
LOWER EXTREMITY FUNCTIONAL SCALE (LEFS)
Measured: 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
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
Ultrasonography
Ultrasound imaging techniques allow visualization of the bursa area, as the ultrasound beam can penetrate this region. These images enable detailed, multidimensional visualization of the joints and adjacent structures. They also allow precise differentiation of different tissue types, such as soft tissue, bone, or fluids. This is a noninvasive test; it involves placing the transducer on the skin surface, perpendicular to the anatomical location of the bursa.
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 posted1 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BursitisStudies 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
- 120 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
- NCT07099573
- Sponsor's protocol ID
- 140/2025
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 1 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 1 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 Bursitis: a Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07099573
- Acronym / sponsor ID
- 140/2025
- Conditions
- Bursitis, Hyperthermia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 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 bursitis treatment protocol, 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 affected joint, stretching of the involved muscles, and the application of hyperthermia to the bursa and surrounding areas. 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: on the one hand, the objective variable will be measurement and assessment of the bursa using ultrasound imaging. Subjective measurement variables will also be used through validated questionnaires, which will address physical activity, perceived functional limitations, and the visual analog 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 |
| Hyperthermia 3 times per week | Experimental | Radiation: Hyperthermia, Other: Physical Exercise, Other: Stretching |
| Non-Hyperthermia 2 times per week | Experimental | Other: Physical Exercise, Other: Stretching |
| Non-Hyperthermia 3 times per week | Experimental | Other: Physical Exercise, Other: Stretching |
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 imaging test of Bursitis
- 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.
- 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 bursa. | Radiation | Hyperthermia 2 times per week, Hyperthermia 3 times per week |
| Physical ExerciseThe therapeutic physical exercise will consist of 3 periods of isometric contraction of 30 seconds, with a rest period of 1 minute, 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 |
| StretchingStretching of the involved muscles will involve 3 periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds. | 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
DISABILITIES OF THE ARM, SHOULDER AND HAND QUESTIONNAIRE (DASH)
Time frame: Baseline and up to one year
It consists of a self-administered questionnaire that assesses the upper limb as a functional unit and allows for the quantification and comparison of the impact of different processes affecting different regions of the limb. It consists of a core of 30 items and two optional modules, each with four items. Each item is scored from 1 to 5, with higher scores corresponding to greater symptom intensity. The final score can range from 30 to 150 points, with a scale of 0 (best possible score) to 100 (worst possible score). The optional modules are scored separately. The Spanish version has very high reliability (r=0.96).
LOWER EXTREMITY FUNCTIONAL SCALE (LEFS)
Time frame: 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
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.
Ultrasonography
Time frame: Baseline and up to one year
Ultrasound imaging techniques allow visualization of the bursa area, as the ultrasound beam can penetrate this region. These images enable detailed, multidimensional visualization of the joints and adjacent structures. They also allow precise differentiation of different tissue types, such as soft tissue, bone, or fluids. This is a noninvasive test; it involves placing the transducer on the skin surface, perpendicular to the anatomical location of the bursa.
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 1 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 Bursitis 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 1 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?
DISABILITIES OF THE ARM, SHOULDER AND HAND QUESTIONNAIRE (DASH) (time frame: Baseline and up to one year). The study lists 5 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 1 Aug 2025.