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

NCT ID: NCT02578134

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-03-31

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.

Conditions

Plantar Heel Pain, Plantar Fasciosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

US-guided percutaneous electrolysis

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Sham US-guided percutaneous electrolysis

Intervention Type: 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.

Interventions

US-guided percutaneous electrolysis

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

Intervention Type: OTHER

Sham 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

César Fernández-de-las-Peñas

Head Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, Spain

Countries

Spain

Other Identifiers

URJC 09-2015

Identifier Type: -

Identifier Source: org_study_id