Plantar Heel Pain, Plantar Fasciosis Clinical Trial
Official title:
Effectiveness of US-guided Percutaneous Electrolysis (EPE®) Versus Placebo in Individuals With Plantar Fasciosis
| Verified date | March 2016 |
| Source | Universidad Rey Juan Carlos |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Comité Ético de Investigación Clínica |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - insidious onset of sharp pain under the plantar heel surface upon weight bearing after a period of non-weight bearing; - plantar heel pain which increases in the morning with the first steps after waking up; - symptoms decreasing with slight levels of activity, such as walking. Exclusion Criteria: - prior surgery in the lower extremity; - diagnosis of fibromyalgia syndrome; - previous physical therapy interventions for the foot region in the previous 6 months - lidocaine or other injections in the plantar fascia for the management of pain in the previous 6 months |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Cesar Fernandez-de-Las-Peñas | Alcorcon | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Rey Juan Carlos |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | Changes in thickness of the plantar fascia | 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 | Yes |