US-guided Percutaneous Electrolysis (EPE®) in Plantar Fasciosis

Not Applicable

Withdrawn

• Conditions: Plantar Heel Pain, Plantar Fasciosis

• Registration Number: NCT02578134
• Lead Sponsor: Universidad Rey Juan Carlos

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-16
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in disability before and after the intervention	Baseline, one week after the last session, and 3 months after the last session	The Foot and Ankle Ability Measure (FAAM) will be used to determine function and disability of the lower extremity induced by plantar heel pain

Secondary Outcome Measures

Name	Time	Method
Changes in thickness of the plantar fascia	Baseline, one week after the last session, and 3 months after the last session	An ultrasound (US) assessment of the thickness of the plantar fascia will be conducted to determine changes in fascial tissue thickness
Changes in pain intensity before and after the intervention	Baseline, one week after the last session, and 3 months after the last session	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

Trial Locations

Locations (1)

Cesar Fernandez-de-Las-Peñas; 🇪🇸 Alcorcon, Madrid, Spain