US-guided Percutaneous Electrolysis (EPE®) in Plantar Fasciosis
- Conditions
- Plantar Heel Pain, Plantar Fasciosis
- Interventions
- Other: US-guided percutaneous electrolysisOther: Sham US-guided percutaneous electrolysis
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
- Arm && Interventions
Group Intervention Description US-guided percutaneous electrolysis US-guided percutaneous electrolysis 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. Sham US-guided percutaneous electrolysis Sham US-guided percutaneous electrolysis 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.
- 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