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Trial registered on ANZCTR


Registration number
ACTRN12616001430426
Ethics application status
Approved
Date submitted
29/09/2016
Date registered
13/10/2016
Date last updated
16/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound-guided Percutaneous Electrolysis in Chronic Plantar Heel Pain. A randomized clinical trial.
Scientific title
Effectiveness of US-guided Percutaneous Electrolysis Versus Placebo in Individuals With Plantar Fasciosis
Secondary ID [1] 290242 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar Fasciosis 300438 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300301 300301 0 0
Other physical medicine / rehabilitation
Musculoskeletal 300375 300375 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Treatment will be applied by Physical Therapist/Medical Doctor with minimum 5 years of experience in ultrasound-guided invasive techniques.

Dosage: 350 microamperes (28 microcoulombs)
Duration: 3 approaches of 80 second each one inside the plantar fascia insertion, on the same visit, once per week
Mode: Percutaneous
Galvanic Device: EPTE device (Registered Trademark). Max 48 Volts, 1000 microamps.
Ultrasound Device: Mindray (Registered Trademark) M7 ultrasound system with linear L12-4s transducer
Adherence monitoring: Not applicable
Intervention code [1] 296023 0
Rehabilitation
Intervention code [2] 296024 0
Treatment: Devices
Comparator / control treatment
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. Patients will be blinded to the application of galvanic electrical current.
Control group
Placebo

Outcomes
Primary outcome [1] 299778 0
Changes in pain intensity before and after the intervention 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.
Timepoint [1] 299778 0
Baseline, one week after the last session, 3 and 6 months after the last session.
Secondary outcome [1] 328092 0
Changes in disability before and after the intervention The Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subescale ( 21 items; scores from 4 to 0, being 4 "no difficulty" and 0 "unable to do". Item score totals range from 0 to 84 ) will be used to determine function and disability of the lower extremity induced by plantar heel pain.
Timepoint [1] 328092 0
Baseline, one week after the last session, 3 and 6 months after the last session.
Secondary outcome [2] 328093 0
Changes in thickness of the plantar fascia in centimeters. An ultrasound (US) assessment of the thickness of the plantar fascia (mm) will be conducted to determine changes in fascial tissue thickness.
Timepoint [2] 328093 0
Baseline, one week after the last session, 3 and 6 months after the last session.

Eligibility
Key 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.

Plantar fascia ultrasound thickness greater than 0,4 cm.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.

Group A or B are linked to a pre-designed CE electrolysis device, being one of them a placebo device.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Referring to the sample size, was calculated based on previous studies, indicating that 34 participants per group would provide 80% power to detect an expected 30% difference in improvement in pain scores on the NPRS scale, assuming a standard deviation of 20, an alpha level (a) of 0.05, and a 10% loss to follow-up.

Following the review of the base and its closure will proceed to statistical analysis using SPSS version 20 programs and STATA version 12. Statistical analysis will be performed by data statistician from outside the study.

An initial comparison of groups to assess the homogeneity thereof and therefore the correct randomization is performed. This will be done by clinical relevance, according to CONSORT regulations, and statistical tests were applied to evaluate the alpha error depending on the type of variables.

In the case of qualitative variables with test of chi-square test or Fisher and in case of quantitative variables expressed as mean and standard deviation with analysis of variance and test of Student t test for independent samples or test the median if the distribution of the variable is asymmetric, expressed in median and interquartile range. If significant differences are detected in this comparison linear models to evaluate be adjusted confusion that might introduce in the efficacy analysis.

The assessment of the primary efficacy was performed by comparison of means, both independently in groups and paired baseline versus end by analysis of covariance analysis corrigendum significance level for multiple contrasts with Dunnet's test. the absolute and relative effects with their IC95%. In the case of qualitative variables security comparison will be made with the chi-square test or the Fisher exact test were estimated. The significance level is 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8278 0
Spain
State/province [1] 8278 0
Madrid

Funding & Sponsors
Funding source category [1] 294609 0
University
Name [1] 294609 0
Camilo Jose Cela University
Address [1] 294609 0
Castillo de Alarcon, 49 Street. Villafranca del Castillo, Madrid. Spain
Country [1] 294609 0
Spain
Primary sponsor type
University
Name
Camilo Jose Cela University
Address
Castillo de Alarcon, 49 Street. Villafranca del Castillo, Madrid. Spain
Country
Spain
Secondary sponsor category [1] 293473 0
None
Name [1] 293473 0
Address [1] 293473 0
Country [1] 293473 0
Other collaborator category [1] 279769 0
University
Name [1] 279769 0
Valencia University
Address [1] 279769 0
Blasco Ibanez Avenue, 13, 46010, Valencia, Comunidad Valenciana, Spain.
Country [1] 279769 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296052 0
Camilo Jose Cela Clinical Research Ethics Committee
Ethics committee address [1] 296052 0
Physical Therapy Department. Camilo Jose Cela University. Castillo de Alarcon, 49 Street. Villafranca del Castillo, 28692. Madrid
Ethics committee country [1] 296052 0
Spain
Date submitted for ethics approval [1] 296052 0
25/03/2016
Approval date [1] 296052 0
13/10/2014
Ethics approval number [1] 296052 0
CEI-UCJC-EPTEFASC 10/2016

Summary
Brief summary
Plantar fasciosis is a chronic degenerative process of the plantar fascia. Etiology is not entirely known; is argued that can be caused by repetitive microtrauma. The typical symptom is plantar medial heel pain, which is more noticeable with initial steps after a period of inactivity and continues to deteriorate after prolonged weight bearing (Neufeld, 2007).

The current histological findings published on plantar fasciitis support the nonexistence of inflammatory mediators; show a myxoid tissue degeneration, loss of fiber orientation, collagen necrosis and angiofybroblastic hyperplasia. These characteristics are related to degenerative processes without inflammation of the fascia or plantar fasciosis (Lemont, 2003). 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. In acute stages, therapeutic medical invasive treatments as glucocorticoids infiltrations counters inflammation. On the other hand, in chronic stages we can induce this inflammation by applying a galvanic low-current through an acupuncture needle, in order to induce a local process of electrolysis.The chemical reaction that takes place under the cathode produces changes in the damaged tissue by the formation of an alkaline controlled burn in the extracellular medium. This leads to an inflammatory response and tissue ablation, restarting the regenerative process. The destroyed tissue is metabolized by the body itself through phagocytosis (Martínez Morillo M, 1998; Martin Cordero JE, 2008).

The Therapeutic Percutaneous Electrolysis device (EPTE Registered Trademark System; EPTE Manual, 2014 IONCLINICS & DEIONIC, SL) is a tool that enables to access to the soft tissue dysfunction and apply a local treatment that involves a galvanic current through an acupuncture needle with high accuracy, since the treatment is performed with an ultrasound device. The EPTE device (Registered Trademark) has proven its effectivity in the treatment of tendonitis (Arias, 2015) and we hypothesize that it could also be effective in other connective tissue of different density, and with similarities in pathophysiology and histopathology, as the plantar fascia is.

Therefore, the proposal of this research is to evaluate the efficacy of the Ultrasound-guided Percutaneous Electrolysis treatment, in the degenerated plantar fasiosis, versus patients which only receive a placebo treatment.
Trial website
Trial related presentations / publications
Public notes
Last clinical ethics application review made on 10/2016 as CEI-UCJC-EPTEFASC 10/2016.

Contacts
Principal investigator
Name 69354 0
Mr Alvaro Fernandez-Rolle
Address 69354 0
Physical Therapy Department. Camilo Jose Cela University. Castillo de Alarcon, 49 Street. Villafranca del Castillo, 28692. Madrid
Country 69354 0
Spain
Phone 69354 0
+34689298911
Fax 69354 0
Email 69354 0
alvaro.fernandez@alumno.ucjc.edu
Contact person for public queries
Name 69355 0
A/Prof Sebastian Truyols-Dominguez
Address 69355 0
Physical Therapy Department. Camilo Jose Cela University. Castillo de Alarcon, 49 Street. Villafranca del Castillo, 28692. Madrid
Country 69355 0
Spain
Phone 69355 0
+34918153131
Fax 69355 0
Email 69355 0
struyols@ucjc.edu
Contact person for scientific queries
Name 69356 0
Dr Tomas Fernandez-Rodriguez
Address 69356 0
Physical Therapy Department. Camilo Jose Cela University. Castillo de Alarcon, 49 Street. Villafranca del Castillo, 28692. Madrid
Country 69356 0
Spain
Phone 69356 0
+34918153131
Fax 69356 0
Email 69356 0
popeyetuna@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary