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Not yet recruitingNCT07099573Updated Aug 1, 2025

Analysis of Hyperthermia as an Adjunctive Treatment to Evidence-based Clinical Intervention in Subjects With Bursitis: a Double-blind Randomized Clinical Trial

An interventional study of Hyperthermia and Physical Exercise in Bursitis and Hyperthermia, sponsored by University of Malaga. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by University of Malaga · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bursitis
  • Hyperthermia
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have a diagnosis confirmed by performing an imaging test of Bursitis
  • Have not yet received physiotherapy treatment.

Exclusion criteria

Exclusion Criteria:

  • Have undergone surgery.
  • Those who refuse to participate in this study.
  • Patients with muscle atrophy.
  • Medical conditions that are contraindications for hyperthermia therapy.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Hyperthermia 2 times per week

    Radiation: Hyperthermia · Other: Physical Exercise · Other: Stretching

  • Experimental
    Hyperthermia 3 times per week

    Radiation: Hyperthermia · Other: Physical Exercise · Other: Stretching

  • Experimental
    Non-Hyperthermia 2 times per week

    Other: Physical Exercise · Other: Stretching

  • Experimental
    Non-Hyperthermia 3 times per week

    Other: Physical Exercise · Other: Stretching

Interventions

  • RadiationHyperthermia

    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.

  • OtherPhysical Exercise

    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.

  • OtherStretching

    Stretching of the involved muscles will involve 3 periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline and up to one year

  2. 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

  3. 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).

    Time frame: Baseline and up to one year

  4. 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.

    Time frame: Baseline and up to one year

  5. 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.

    Time frame: Baseline and up to one year

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07099573
Lead sponsor
University of Malaga
Responsible party
Dr. Manuel González-Sánchez (Principal Investigator, University of Malaga) — Principal investigator
First posted
Aug 1, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
Oct 31, 2025 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Aug 1, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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