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Trial record 2 of 17 for:    Percutaneous electrolysis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02578134
Recruitment Status : Withdrawn
First Posted : October 16, 2015
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE October 16, 2015
Last Update Posted Date March 15, 2016
Study Start Date  ICMJE October 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
Changes in disability before and after the intervention [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • Changes in pain intensity before and after the intervention [ Time Frame: 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
  • Changes in thickness of the plantar fascia [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE US-guided Percutaneous Electrolysis (EPE®) in Plantar Fasciosis
Official Title  ICMJE Effectiveness of US-guided Percutaneous Electrolysis (EPE®) Versus Placebo in Individuals With 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plantar Heel Pain, Plantar Fasciosis
Intervention  ICMJE
  • Other: 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
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Other: US-guided percutaneous electrolysis
  • Sham Comparator: 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.
    Intervention: Other: Sham US-guided percutaneous electrolysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 14, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2015)
50
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02578134
Other Study ID Numbers  ICMJE URJC 09-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
Study Sponsor  ICMJE Universidad Rey Juan Carlos
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad Rey Juan Carlos
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP