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Scientific evidence of conservative management of individuals with plantar fasciosis is sometimes conflicting. There is evidence that regular exercise programs are effective for this pain condition. The inclusion of other therapeutic modalities is still controversial. Some authors have suggested that the use of US-guided percutaneous electrolysis (EPE®) maybe useful for the management of chronic tendinopathies; however, no study has investigated the potential placebo effect of this intervention. The objective of this randomized clinical trial is to determine the effectiveness of US-guided percutaneous electrolysis (EPE®) versus sham US-guided percutaneous electrolysis for the management of patients with plantar fasciosis for pain, function, and disability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US-guided percutaneous electrolysis | Experimental | Patients will receive one weekly session for 5 weeks for 5 weeks of US-guided percutaneous electrolysis. This intervention consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the plantar fascia insertion. In addition, patients will be asked for conducting a best-evidence low-load exercise programs for the intrinsic foot musculature. The exercise program will be asked to be performed on an individual basis twice every day. |
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| Sham US-guided percutaneous electrolysis | Sham Comparator | Patients will receive one weekly session for 5 weeks for 5 weeks of sham US-guided percutaneous electrolysis. In this case, the acupuncture needle will be inserted in the soft tissue, in this case the plantar fascia insertion without the application of the galvanic electrical current. In addition, patients will be asked for conducting a best-evidence low-load exercise programs for the intrinsic foot musculature. The exercise program will be asked to be performed on an individual basis twice every day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| US-guided percutaneous electrolysis | Other | US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the symptomatic insertion of the plantar fascia |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in disability before and after the intervention | The Foot and Ankle Ability Measure (FAAM) will be used to determine function and disability of the lower extremity induced by plantar heel pain | Baseline, one week after the last session, and 3 months after the last session |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pain intensity before and after the intervention | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of plantar heel pain | Baseline, one week after the last session, and 3 months after the last session |
| Changes in thickness of the plantar fascia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cesar Fernandez-de-Las-Peñas | Alcorcón | Madrid | 28921 | Spain |
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| Sham US-guided percutaneous electrolysis | Other | The acupuncture needle will be inserted into the symptomatic plantar fascia but no galvanic electrical current will be applied, the equipment will be turn off. Patients will be blinded to the application of galvanic electrical current. |
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An ultrasound (US) assessment of the thickness of the plantar fascia will be conducted to determine changes in fascial tissue thickness |
| Baseline, one week after the last session, and 3 months after the last session |