Plantar FasciitisElectrolysisNCT06674902
Electrolysis in Patients With Chronic Plantar Fasciitis
A study testing Electrolysis Percutaneous Therapeutic (EPTE) in people with Plantar Fasciitis, run by Wroclaw University of Health and Sport Sciences at 1 site in Spain.
Trial summary
Aim of the Study The aim of this study is to investigate the differential effects of high-intensity and low-intensity percutaneous electrolysis (PCE) on pain perception and muscle tissue properties in individuals with chronic plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Electrolysis Percutaneous Therapeutic (EPTE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18 years or older,
- unilateral heel pain lasting longer than 3 months,
- a clinical diagnosis of chronic plantar fasciitis according to the clinical practice guidelines of the Orthopaedic Section of the American Physical Therapy Association (APTA), i.e., sudden onset of pain on the plantar surface of the heel after a period of non-weight bearing, pain that is worse in the morning with the first step, and tenderness to palpation at the proximal attachment site of the plantar fascia.
Who cannot join
- previous lower extremity surgery,
- the presence of positive neurological signs consistent with nerve root compression,
- any medical conditions causing heel pain, such as rheumatoid arthritis, diabetes, or peripheral neuropathy,
- receipt of any foot treatment within the past 6 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Short-term Effectiveness of High- and Low-intensity Percutaneous Electrolysis in Patients With Plantar Fasciitis
Aim of the Study
The aim of this study is to investigate the differential effects of high-intensity and low-intensity percutaneous electrolysis (PCE) on pain perception and muscle tissue properties in individuals with chronic plantar fasciitis.
Research Questions
Pain Perception:
Does high-intensity PCE induce greater changes in pressure pain threshold (PPT) in the plantar fascia compared to low-intensity PCE in individuals with chronic plantar fasciitis?
Muscle Tissue Properties:
Does high-intensity PCE reduce stiffness in the plantar fascia to a greater extent than low-intensity PCE in individuals with chronic plantar fasciitis?
Read the detailed description
A randomized, controlled, triple-blind clinical trial will be conducted to compare the effects of a single session of percutaneous intertissued electrolysis in three different modes (two intervention groups with the same dose but different intensity and time parameters, and one intervention group with a different dose) in patients with chronic plantar fasciitis (PF).
This study will be conducted under the Consolidated Standards of Reporting Trials (CONSORT) guidelines for pragmatic clinical trials and the EQUATOR guidelines to improve health research quality and transparency. Since the study involves patients with plantar pain, participants' rights will be respected under the Declaration of Helsinki. The Ethics Committee of University Hospital 12 de Octubre must approve the study protocol before data collection begins. The study protocol will also be prospectively registered on ClinicalTrials.org before data collection begins.
Sociodemographic variables (age, sex, weight, height, and body mass index), clinical variables (pain intensity, disability related to PF, pain thresholds to pressure), mechanical variables (plantar fascia stiffness), and tolerance to the treatment (visual analog scale to assess the intensity of pain felt during the intervention) will be assessed. Sociodemographic variables will be collected before the intervention, clinical and mechanical variables before and after the intervention, and tolerance to treatment only after the intervention. The assessment of participants will be carried out by an assessor who will not know which intervention group the participant belongs to. Participants will not know what dose they received, and the physiotherapists performing the procedures will also not know what settings the electrotherapy device has.
Participants will be randomly assigned to one of three intervention groups using a random number generator (Research Randomizer, version 4.0). Individual cards with numbers assigned sequentially according to the randomization will be used, which will then be folded and placed in opaque, sealed envelopes to ensure the concealment of allocation. An external researcher will select the envelope and make the assignment, which will only be revealed to the external therapist setting the equipment parameters after the initial data collection is completed. The assessor, therapist, and participants will not know to which group they have been assigned.
- Conditions
- Plantar Fasciitis
- Being tested
- Electrolysis Percutaneous Therapeutic (EPTE)
- Keywords
- Pain, Electrolysis, shear-wave elastography, pain sensitivity
- Medical subject headings
- Fasciitis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrolysis Percutaneous Therapeutic (EPTE)Device
EPTE device (Ionclinics, Valencia, Spain)
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1: Electrolysis with 4 mA | Experimental | A charge of 24 mC will be delivered at 4 mA for 6 seconds, followed by a 54-second pause. Receives: Device: Electrolysis Percutaneous Therapeutic (EPTE) |
| Experimental 2: Electrolysis with 400 μA | Experimental | A charge of 24 mC will be delivered at 400 µA for 60 seconds. Receives: Device: Electrolysis Percutaneous Therapeutic (EPTE) |
| Experimental 3: Electrolysis with 600 μA | Experimental | A charge of 36 mC will be delivered at 600 µA for 60 seconds. Receives: Device: Electrolysis Percutaneous Therapeutic (EPTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Participants will rate their pain intensity on an 11-point numeric rating scale (NPRS; 0 = no pain; 10 = worst possible pain). They will consider the pain intensity of their first step in the morning, the average pain intensity during the day, and the maximum pain experienced in the past week. The average of all these values will be used to calculate a pain intensity score for the primary analysis.
Measured: Baseline, immediately after
Secondary outcomes (4)
Foot function
Foot function will be assessed using the Foot Function Index (FFI), the most commonly used self-assessment tool for the foot. The FFI has been shown to be reliable, valid, and sensitive to change in individuals with chronic plantar heel pain.
The Foot Function Index (FFI) consists of 23 self-reported questions divided into three subscales: pain (nine items), disability (nine items), and activity limitation (five items). Each item is rated on a 0-10 scale (0 = no pain or difficulty, 10 = worst possible pain or difficulty requiring help). Each subscale is scored as a percentage from 0% to 100%, with higher scores indicating lower function and poorer foot-related health-related quality of life. In this study, the total FFI score, calculated as the average of the three subscales, will be used for the primary analysis.
Measured: Baseline, immediately after
Pain threshold
Participants will avoid pain meds/muscle relaxants for 24 hours. PPT will be measured using an electronic algometer at 30 kPa/s, with 3 measurements per site and a 30-second interval. PPT will be assessed bilaterally at the calcaneus, adjacent muscles, tibialis anterior, and a pain-free site. Inter-rater reliability: 0.74-0.97.
Measured: Baseline, immediately after
Tolerance
Participants will rate the intensity of pain experienced during the intervention on an 11-point numeric rating scale (NPRS; 0 = no pain; 10 = worst possible pain).
Measured: Baseline, during intervention, immediately after
Tissue stiffness
All images will be acquired using a General Electric Logiq P9 ultrasound system equipped with a linear 4-15 MHz probe, located in the Rehabilitation Department of the 12 de Octubre Hospital. Experienced researchers, with over 10 years of experience in musculoskeletal ultrasound and blinded to participant group assignment, will perform the imaging. Device parameters will be identical for all measurements (gain 55 dB, dynamic range 85, brightness 17, depth 4 cm, frequency 8 MHz). The plantar fascia image will be acquired in a longitudinal plane. Subsequently, shear wave elastography mode will be activated, and a region of interest 1 cm wide (corresponding to the width of the algometer head) and an appropriate height to analyze the entire thickness of the fascia will be marked. The ultrasound system will automatically calculate tissue stiffness parameters within the marked region (shear wave velocity and Young's modulus).
Measured: Baseline, immediately after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start11 Nov 2024 (estimated)
- Primary completion22 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A triple-blinded, pilot randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid, Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Sebastian Klich, Wroclaw University of Health and Sport Sciences
- Investigators
- Juan Antonio Valera-Calero, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674902
- Sponsor's protocol ID
- UCM#2
- Other IDs
- #19/044
- Acronym
- Electrolysis
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alburquerque-Sendin F, Rios-Leon M, Valera-Calero JA, Plaza-Manzano G, Fernandez-de-Las-Penas C, Ortega-Santiago R, Priscila Rodrigues-de-Souza D. Clinical, Psychological, and Neurophysiological Outcomes Associated with Pain and Function in Individuals with Unilateral Plantar Heel Pain. Pain Med. 2022 Aug 31;23(9):1613-1620. doi: 10.1093/pm/pnac018.
PubMed 35089360Rios-Leon M, Valera-Calero JA, Ortega-Santiago R, Varol U, Fernandez-de-Las-Penas C, Plaza-Manzano G. Analyzing the Interaction between Clinical, Neurophysiological and Psychological Outcomes Underlying Chronic Plantar Heel Pain: A Network Analysis Study. Int J Environ Res Public Health. 2022 Aug 18;19(16):10301. doi: 10.3390/ijerph191610301.
PubMed 36011936Valera-Calero JA, Sanchez-Mayoral-Martin A, Varol U. Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study. World J Orthop. 2021 Oct 18;12(10):781-790. doi: 10.5312/wjo.v12.i10.781. eCollection 2021 Oct 18.
PubMed 34754834
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effectiveness of High- and Low-intensity Percutaneous Electrolysis in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06674902
- Acronym / sponsor ID
- Electrolysis / UCM#2
- Conditions
- Plantar Fasciitis
- Keywords
- Pain, Electrolysis, shear-wave elastography, pain sensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid, Universidad Rey Juan Carlos
- Study start
- 11 Nov 2024 (estimated)
- Primary completion
- 22 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the Study
The aim of this study is to investigate the differential effects of high-intensity and low-intensity percutaneous electrolysis (PCE) on pain perception and muscle tissue properties in individuals with chronic plantar fasciitis.
Research Questions
Pain Perception:
Does high-intensity PCE induce greater changes in pressure pain threshold (PPT) in the plantar fascia compared to low-intensity PCE in individuals with chronic plantar fasciitis?
Muscle Tissue Properties:
Does high-intensity PCE reduce stiffness in the plantar fascia to a greater extent than low-intensity PCE in individuals with chronic plantar fasciitis?
Detailed description
A randomized, controlled, triple-blind clinical trial will be conducted to compare the effects of a single session of percutaneous intertissued electrolysis in three different modes (two intervention groups with the same dose but different intensity and time parameters, and one intervention group with a different dose) in patients with chronic plantar fasciitis (PF).
This study will be conducted under the Consolidated Standards of Reporting Trials (CONSORT) guidelines for pragmatic clinical trials and the EQUATOR guidelines to improve health research quality and transparency. Since the study involves patients with plantar pain, participants' rights will be respected under the Declaration of Helsinki. The Ethics Committee of University Hospital 12 de Octubre must approve the study protocol before data collection begins. The study protocol will also be prospectively registered on ClinicalTrials.org before data collection begins.
Sociodemographic variables (age, sex, weight, height, and body mass index), clinical variables (pain intensity, disability related to PF, pain thresholds to pressure), mechanical variables (plantar fascia stiffness), and tolerance to the treatment (visual analog scale to assess the intensity of pain felt during the intervention) will be assessed. Sociodemographic variables will be collected before the intervention, clinical and mechanical variables before and after the intervention, and tolerance to treatment only after the intervention. The assessment of participants will be carried out by an assessor who will not know which intervention group the participant belongs to. Participants will not know what dose they received, and the physiotherapists performing the procedures will also not know what settings the electrotherapy device has.
Participants will be randomly assigned to one of three intervention groups using a random number generator (Research Randomizer, version 4.0). Individual cards with numbers assigned sequentially according to the randomization will be used, which will then be folded and placed in opaque, sealed envelopes to ensure the concealment of allocation. An external researcher will select the envelope and make the assignment, which will only be revealed to the external therapist setting the equipment parameters after the initial data collection is completed. The assessor, therapist, and participants will not know to which group they have been assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A triple-blinded, pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental 1: Electrolysis with 4 mA | Experimental | Device: Electrolysis Percutaneous Therapeutic (EPTE)A charge of 24 mC will be delivered at 4 mA for 6 seconds, followed by a 54-second pause. |
| Experimental 2: Electrolysis with 400 μA | Experimental | Device: Electrolysis Percutaneous Therapeutic (EPTE)A charge of 24 mC will be delivered at 400 µA for 60 seconds. |
| Experimental 3: Electrolysis with 600 μA | Experimental | Device: Electrolysis Percutaneous Therapeutic (EPTE)A charge of 36 mC will be delivered at 600 µA for 60 seconds. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18 years or older,
- unilateral heel pain lasting longer than 3 months,
- a clinical diagnosis of chronic plantar fasciitis according to the clinical practice guidelines of the Orthopaedic Section of the American Physical Therapy Association (APTA), i.e., sudden onset of pain on the plantar surface of the heel after a period of non-weight bearing, pain that is worse in the morning with the first step, and tenderness to palpation at the proximal attachment site of the plantar fascia.
Key exclusion criteria (4 listed)
- previous lower extremity surgery,
- the presence of positive neurological signs consistent with nerve root compression,
- any medical conditions causing heel pain, such as rheumatoid arthritis, diabetes, or peripheral neuropathy,
- receipt of any foot treatment within the past 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrolysis Percutaneous Therapeutic (EPTE)EPTE device (Ionclinics, Valencia, Spain) | Device | Experimental 1: Electrolysis with 4 mA, Experimental 2: Electrolysis with 400 μA, Experimental 3: Electrolysis with 600 μA |
Primary outcome
Pain intensity
Time frame: Baseline, immediately after
Participants will rate their pain intensity on an 11-point numeric rating scale (NPRS; 0 = no pain; 10 = worst possible pain). They will consider the pain intensity of their first step in the morning, the average pain intensity during the day, and the maximum pain experienced in the past week. The average of all these values will be used to calculate a pain intensity score for the primary analysis.
4 secondary outcomes
Foot function
Time frame: Baseline, immediately after
Pain threshold
Time frame: Baseline, immediately after
Tolerance
Time frame: Baseline, during intervention, immediately after
Tissue stiffness
Time frame: Baseline, immediately after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 35089360Alburquerque-Sendin F, Rios-Leon M, Valera-Calero JA, Plaza-Manzano G, Fernandez-de-Las-Penas C, Ortega-Santiago R, Priscila Rodrigues-de-Souza D. Clinical, Psychological, and Neurophysiological Outcomes Associated with Pain and Function in Individuals with Unilateral Plantar Heel Pain. Pain Med. 2022 Aug 31;23(9):1613-1620. doi: 10.1093/pm/pnac018.
- Background: PubMed 36011936Rios-Leon M, Valera-Calero JA, Ortega-Santiago R, Varol U, Fernandez-de-Las-Penas C, Plaza-Manzano G. Analyzing the Interaction between Clinical, Neurophysiological and Psychological Outcomes Underlying Chronic Plantar Heel Pain: A Network Analysis Study. Int J Environ Res Public Health. 2022 Aug 18;19(16):10301. doi: 10.3390/ijerph191610301.
- Background: PubMed 34754834Valera-Calero JA, Sanchez-Mayoral-Martin A, Varol U. Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study. World J Orthop. 2021 Oct 18;12(10):781-790. doi: 10.5312/wjo.v12.i10.781. eCollection 2021 Oct 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Antonio Valera-Calero study director
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrolysis Percutaneous Therapeutic (EPTE) in people with Plantar Fasciitis, run by Wroclaw University of Health and Sport Sciences at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Klich (+48713473176, sebastian.klich@awf.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline, immediately after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674902, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.