MetatarsalgiaNCT05262972
Percutaneous Needle Electrolysis on Metatarsalgia
A study testing Conservatory treatment and Innovate treatment in people with Metatarsalgia, run by University of Seville at 1 site in Spain.
Trial summary
Percutaneous electrolysis is a minimally invasive method that involves the application of a galvanic current through an acupuncture needle. The needle is placed directly into the soft tissue structures, essential with ultrasound guidance. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metatarsalgia
- What is being tested?
- Conservatory treatment and Innovate treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult female patients (40-65 years old)
- Having pain in the 2nd MTP joint of the foot due to pathology of the plantar plate, diagnosed by a specialized professional.
Who cannot join
- to have suffered an injury to their musculoskeletal system in the last 6 months.
- to have the present neuritic pathology,
- to have complete rupture of the plantar plate, 2nd finger supraadductus, flexor digitorum longus tenosynovitis,
- to have problems in the lumbar spine,
- to have undergone surgery in the lumbar spine or lower limbs.
- to use a plantar orthosis.
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- to have the presence of associated pathologies in the foot,
- to be under the influence of any medication at the time of the study, fear of needles
- to be pregnant
- to be epileptic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: APPLICATION OF ULTRASOUND-GUIDED PERCUTANEOUS ELECTROLYSIS IN THE PAIN OF THE SECOND METATARSOPHALANGEAL JOINT IN ADULT WOMEN
Percutaneous electrolysis is a minimally invasive method that involves the application of a galvanic current through an acupuncture needle. The needle is placed directly into the soft tissue structures, essential with ultrasound guidance. This technique involves the combination of mechanical stimulation produced by the needle and electrical/biochemical stimulation provided by the electrical current.
Endogenous pain modulation shows clinical relevance of this technique and plays an important role in the experience of pain.
Plantar plate injury is a pathology that frequently occurs in the forefoot, especially in middle-aged women, causing metatarsalgia that is sometimes very intense. In most cases it is secondary to a mechanical imbalance of the forefoot, related to an insufficiency of the first radius. For this reason, the researchers hypothesize that the application of ultrasound-guided percutaneous electrolysis on the plantar plate, combined with the conservative treatment consisting of the development of a personalized plantar orthosis, can cause positive effects in the patient's clinic as well as improve their quality of life.
- Conditions
- Metatarsalgia
- Being tested
- Conservatory treatment, Innovate treatment
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservatory treatmentOther
Personalized plantar orthosis
Innovate treatmentOther
Personalized plantar orthosis + percutaneous electrolysis
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | The subject will obtain a conservative treatment for this type of pathology consisting of the development of a personalized plantar orthosis Receives: Other: Conservatory treatment |
| Group II | Experimental | The subjects belonging to this group, in addition to providing their corresponding personalized plantar orthosis, will receive a complementary treatment consisting of the application of ultrasound-guided percutaneous electrolysis Receives: Other: Innovate treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Foot Health Status Questionnaire
Measured: 1 month
Subjetive level of pain
Intensity of subjective pain in the injured structure (0, no pain; 10, worse pain)
Measured: 1 month
level of pain at palpation
Intensity of pain on palpation in the injured structure (0, no pain; 10, worse pain)
Measured: 1 month
Distribution of plantar pressures
Podiatric platform (pressure percentage 0-100%)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2022
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetatarsalgiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca de la Cruz Torres, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262972
- Sponsor's protocol ID
- PNE and metatarsalgia
- Status last verified
- Nov 2022
- First submitted
- 19 Feb 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APPLICATION OF ULTRASOUND-GUIDED PERCUTANEOUS ELECTROLYSIS IN THE PAIN OF THE SECOND METATARSOPHALANGEAL JOINT IN ADULT WOMEN
- ClinicalTrials.gov ID
- NCT05262972
- Acronym / sponsor ID
- PNE and metatarsalgia
- Conditions
- Metatarsalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Mar 2022 (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.
Percutaneous electrolysis is a minimally invasive method that involves the application of a galvanic current through an acupuncture needle. The needle is placed directly into the soft tissue structures, essential with ultrasound guidance. This technique involves the combination of mechanical stimulation produced by the needle and electrical/biochemical stimulation provided by the electrical current.
Endogenous pain modulation shows clinical relevance of this technique and plays an important role in the experience of pain.
Plantar plate injury is a pathology that frequently occurs in the forefoot, especially in middle-aged women, causing metatarsalgia that is sometimes very intense. In most cases it is secondary to a mechanical imbalance of the forefoot, related to an insufficiency of the first radius. For this reason, the researchers hypothesize that the application of ultrasound-guided percutaneous electrolysis on the plantar plate, combined with the conservative treatment consisting of the development of a personalized plantar orthosis, can cause positive effects in the patient's clinic as well as improve their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Conservatory treatmentThe subject will obtain a conservative treatment for this type of pathology consisting of the development of a personalized plantar orthosis |
| Group II | Experimental | Other: Innovate treatmentThe subjects belonging to this group, in addition to providing their corresponding personalized plantar orthosis, will receive a complementary treatment consisting of the application of ultrasound-guided percutaneous electrolysis |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult female patients (40-65 years old)
- Having pain in the 2nd MTP joint of the foot due to pathology of the plantar plate, diagnosed by a specialized professional.
Key exclusion criteria (10 listed)
- to have suffered an injury to their musculoskeletal system in the last 6 months.
- to have the present neuritic pathology,
- to have complete rupture of the plantar plate, 2nd finger supraadductus, flexor digitorum longus tenosynovitis,
- to have problems in the lumbar spine,
- to have undergone surgery in the lumbar spine or lower limbs.
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 |
|---|---|---|
| Conservatory treatmentPersonalized plantar orthosis | Other | Group I |
| Innovate treatmentPersonalized plantar orthosis + percutaneous electrolysis | Other | Group II |
Primary outcome
Quality of life
Time frame: 1 month
Foot Health Status Questionnaire
Subjetive level of pain
Time frame: 1 month
Intensity of subjective pain in the injured structure (0, no pain; 10, worse pain)
level of pain at palpation
Time frame: 1 month
Intensity of pain on palpation in the injured structure (0, no pain; 10, worse pain)
Distribution of plantar pressures
Time frame: 1 month
Podiatric platform (pressure percentage 0-100%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservatory treatment and Innovate treatment in people with Metatarsalgia, run by University of Seville 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blanca De la Cruz Torres, Dr (666676870, bcruz@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022.