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

U

Universidad Rey Juan Carlos

Status

Withdrawn

Conditions

Plantar Heel Pain, Plantar Fasciosis

Treatments

Other: Sham US-guided percutaneous electrolysis
Other: US-guided percutaneous electrolysis

Study type

Interventional

Funder types

Other

Identifiers

NCT02578134
URJC 09-2015

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

US-guided percutaneous electrolysis
Experimental group
Description:
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.
Treatment:
Other: US-guided percutaneous electrolysis
Sham US-guided percutaneous electrolysis
Sham Comparator group
Description:
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.
Treatment:
Other: Sham US-guided percutaneous electrolysis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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