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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Malaga

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a diagnosis confirmed by performing an imaging test of Bursitis

Have not yet received physiotherapy treatment.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hyperthermia

    Radiation

    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 Exercise

    Other intervention

    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.

  • Stretching

    Other intervention

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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Hyperthermia 2 times per weekExperimental treatment 3 interventions
Group B: Hyperthermia 3 times per weekExperimental treatment 3 interventions
Group C: Non-Hyperthermia 2 times per weekExperimental treatment 2 interventions
Group D: Non-Hyperthermia 3 times per weekExperimental treatment 2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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