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

University of Malaga

Status: Not yet enrolling

Conditions: Hyperthermia; Bursitis

Treatments: Other: Physical Exercise; Radiation: Hyperthermia; Other: Stretching

Study type: Interventional

Funder types: Other

Identifiers

NCT07099573

140/2025

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

Hyperthermia 2 times per week

Experimental group

Treatment:

Other: Stretching

Radiation: Hyperthermia

Other: Physical Exercise

Hyperthermia 3 times per week

Experimental group

Treatment:

Other: Stretching

Radiation: Hyperthermia

Other: Physical Exercise

Non-Hyperthermia 2 times per week

Experimental group

Treatment:

Other: Stretching

Other: Physical Exercise

Non-Hyperthermia 3 times per week

Experimental group

Treatment:

Other: Stretching

Other: Physical Exercise