Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intense therapeutic Ultrasound | Experimental | During the trial two applications of 1000 pulses each one (day one and day thirty) will be applied. Pulse regulation could be modified from 4 to 5 joules depending the presence or not of pain. Conservative treatment of plantar fasciitis include: custom made foot orthosis with the same general characteristics plus plantar fasciia and achilles tendon stretching. |
|
| Control group | No Intervention | Non ITU application. Conservative treatment of plantar fasciitis include: custom made foot orthosis with the same general characteristics plus plantar fasciia and achilles tendon stretching. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intense Therapeutic Ultrasound | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction | 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. | 24 weeks |
| Plantar fasciia thickness reduction | Longitudinal view of the plantar fasciia with the use of ultrasound probe. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoechoic volume area reduction | Longitudinal and transversal view of the hypoechoic area of plantar fasciia with the use of ultrasound probe. | 24 weeks |
| Ankle range of motion reduction | Goniometry of the ankle in the extended and flexed position of the knee |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raúl J. Molines Barroso, Phd | Contact | 639059104 | +34 | rauljmolines@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| José Luis Lázaro Martínez, Phd | Universidad Complutense Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetic foot Unit Complutense University | Madrid | 28040 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
Not provided
Not provided
Randomized, Non-probabilistic and Superiority Controlled Clinical Trial.
Not provided
Not provided
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.
Not provided
| 24 weeks |
| Time to incorporation to daily live activities | Patients satisfaction scale (6 items) | 24 weeks |
| Autonomous gait without pain in the heel | Patients autonomous gait scale (6 items) | 24 weeks |
| Improvement of patients satisfaction | Patients satisfaction scale (6 items) | 24 weeks |