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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

27/10/2024

Date data sharing statement initially provided

27/10/2024

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Plantar Fasciosis

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

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]

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]

Baseline, one week after the last session, 3 and 6 months after the last session.

Secondary outcome [1]

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]

Baseline, one week after the last session, 3 and 6 months after the last session.

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

3/11/2014

Date of last participant enrolment

Anticipated

Actual

1/09/2016

Date of last data collection

Anticipated

Actual

3/04/2017

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Madrid

Funding & Sponsors

Funding source category [1]

University

Name [1]

Camilo Jose Cela University

Address [1]

Castillo de Alarcon, 49 Street. Villafranca del Castillo, Madrid. Spain

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Valencia University

Address [1]

Blasco Ibanez Avenue, 13, 46010, Valencia, Comunidad Valenciana, Spain.

Country [1]

Spain

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Camilo Jose Cela Clinical Research Ethics Committee

Ethics committee address [1]

Physical Therapy Department. Camilo Jose Cela University. Castillo de Alarcon, 49 Street. Villafranca del Castillo, 28692. Madrid

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

25/03/2016

Approval date [1]

13/10/2014

Ethics approval number [1]

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

Mr Alvaro Fernandez

Address

Physical Therapy Department. Camilo Jose Cela University. Castillo de Alarcon, 49 Street. Villafranca del Castillo, 28692. Madrid

Country

Spain

Phone

+34918153131

Fax

af22@ucjc.edu

Contact person for public queries

Name

Sebastian Truyols-Dominguez

Address

Physical Therapy Department. Camilo Jose Cela University. Castillo de Alarcon, 49 Street. Villafranca del Castillo, 28692. Madrid

Country

Spain

Phone

+34918153131

Fax

struyols@ucjc.edu

Contact person for scientific queries

Name

Tomas Fernandez-Rodriguez

Address

Physical Therapy Department. Camilo Jose Cela University. Castillo de Alarcon, 49 Street. Villafranca del Castillo, 28692. Madrid

Country

Spain

Phone

+34918153131

Fax

popeyetuna@hotmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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