Plantar Fasciitis, Plantar Fasciitis, Chronic, Ultrasound Therapy
Conditions
Brief summary
It was previously hypothesized that patients receiving Intense Therapeutic Ultrasound (ITU) in addition to the standard of care would have a more rapid resolution of pain, faster return to activities, and a decrease in intra- and perifascial lesions.
Detailed description
Intense Therapeutic Ultrasound (ITU) is an established ultrasound-based therapy in which sound waves are concentrated and focused into a well-defined specific area of musculoskeletal tissue. Previous researches hipothesize that the application of ITU improve and accelerate healing in patients with chronic plantar fasciitis.
Interventions
DEVICEIntense Therapeutic Ultrasound
Application of 1000 pulses, until 5000 joules (5 joules per pulse), during approximately 15 minutes, with the possibility of 5 minutes rest, depending on the tolerance of the patient.
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patient located in experimental group will be treated with ITU. Patient located in control group will be treated with the same protocoll of ITU without intensity.
Intervention model description
Randomized, Non-probabilistic and Superiority Controlled Clinical Trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Both sex patients. * Plantar fasciitis diagnosis: pain during walking during the first steps in the morning; pain due to palpation of plantar fasciia insertion. * Chronic pain of at least 6 month. * Longitudinal thickness of the plantar fasciia more than 4 millimeters. * No previous surgery in the plantar fasciia. * No previous application of alternative treatments such us shock waves or injections (last ninety days)
Exclusion criteria
* Platelet count disorder or anticoagulation therapy. * Anti-inflammatories usual treatment for the treatment of plantar fasciitis. * Diabetic foot syndrome. * Presence of metabolic disease such us: hypertension, hiper or hipothyroidism. * Pregnancy or breastfeeding. * Previous treatment with fluoroquinolones antibiotic. * Bilateral plantar fasciitis. * Diagnosed Autoimmune disesase. * Morphofunctional disorders in the foot and ankle. * Diagnosed fibromyalgia. * Heel disestesy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction | 24 weeks | Use of a Subjective Visual Analogue Scale (SVAS): the outmost left (0 cm) was labelled pain absence and the outmost right (10 cm) was labelled the maximum imagined pain. |
| Plantar fasciia thickness reduction | 24 weeks | Longitudinal view of the plantar fasciia with the use of ultrasound probe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to incorporation to daily live activities | 24 weeks | Patients satisfaction scale (6 items) |
| Hypoechoic volume area reduction | 24 weeks | Longitudinal and transversal view of the hypoechoic area of plantar fasciia with the use of ultrasound probe. |
| Improvement of patients satisfaction | 24 weeks | Patients satisfaction scale (6 items) |
| Autonomous gait without pain in the heel | 24 weeks | Patients autonomous gait scale (6 items) |
| Ankle range of motion reduction | 24 weeks | Goniometry of the ankle in the extended and flexed position of the knee |
Countries
Spain
Contacts
Primary ContactRaúl J. Molines Barroso, Phd
Outcome results
None listed