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

University of Malaga

Status: Not yet enrolling

Conditions: Plantar Fascia; Hyperthermia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07103226

139/2025

Details and patient eligibility

About

This project aims to analyze the use of hyperthermia within a treatment protocol for plantar fasciitis, 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 foot muscles and stretching the plantar fascia and posterior chain, hyperthermia on the plantar fascia insertion area in the calcaneus and adjacent areas, and the use of an orthotic insole used for walking. 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: objective variables will be used to measure local pain using an algometer, assess ankle joint range of motion, and use ultrasound imaging techniques. Subjective variables will also be used through validated questionnaires, which will address physical activity, perceived functional limitations in patients with lower limb pathologies, lower limb functional assessment, and a visual analogue scale for pain perception.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis confirmed by performing an ultrasonography of Plantar Fascitis
• Have not yet received physiotherapy treatment.

Exclusion criteria

• Have undergone surgery.
• Those who refuse to participate in this study.
• Patients with muscle atrophy due to plantar fasciitis.
• 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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64 participants in 4 patient groups

Hyperthermia 2 times per week

Experimental group

Treatment:

Other: Physical Exercise

Other: Orthopedic insole

Radiation: Hyperthermia

Other: Stretching

Hyperthermia 3 times per week

Experimental group

Treatment:

Other: Physical Exercise

Other: Orthopedic insole

Radiation: Hyperthermia

Other: Stretching

Non-hyperthermia 2 times per week

Experimental group

Treatment:

Other: Physical Exercise

Other: Orthopedic insole

Other: Stretching

Non-hyperthermia 3 times per week

Experimental group

Treatment:

Other: Physical Exercise

Other: Orthopedic insole

Other: Stretching