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Not yet recruiting NCT07099573

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

No phase Interventional Bursitis Hyperthermia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperthermia, Physical Exercise, Stretching.
Who it may be relevant to
Registry conditions: Bursitis, Hyperthermia. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • DISABILITIES OF THE ARM, SHOULDER AND HAND QUESTIONNAIRE (DASH) [Time frame: Baseline and up to one year]
  • 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]
  • Visual Analogue Scale (VAS) [Time frame: Baseline and up to one year]
  • Ultrasonography [Time frame: Baseline and up to one year]

Eligibility criteria

Inclusion criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07099573 · 140/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗