Skip to content

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

Effectiveness of US-guided Percutaneous Electrolysis (EPE®) Versus Placebo in Individuals With Plantar Fasciosis

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02578134
Enrollment
0
Registered
2015-10-16
Start date
2015-10-31
Completion date
2016-03-31
Last updated
2016-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Heel Pain, Plantar Fasciosis

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.

Interventions

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

OTHERSham US-guided percutaneous electrolysis

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.

Sponsors

Universidad Rey Juan Carlos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in disability before and after the interventionBaseline, one week after the last session, and 3 months after the last sessionThe Foot and Ankle Ability Measure (FAAM) will be used to determine function and disability of the lower extremity induced by plantar heel pain

Secondary

MeasureTime frameDescription
Changes in pain intensity before and after the interventionBaseline, one week after the last session, and 3 months after the last sessionA 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
Changes in thickness of the plantar fasciaBaseline, one week after the last session, and 3 months after the last sessionAn ultrasound (US) assessment of the thickness of the plantar fascia will be conducted to determine changes in fascial tissue thickness

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026