Percutaneous Needle Electrolysis on Metatarsalgia

NCT ID: NCT05262972

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metatarsalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I

The subject will obtain a conservative treatment for this type of pathology consisting of the development of a personalized plantar orthosis

Group Type EXPERIMENTAL

Conservatory treatment

Intervention Type OTHER

Personalized plantar orthosis

Group II

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

Group Type EXPERIMENTAL

Innovate treatment

Intervention Type OTHER

Personalized plantar orthosis + percutaneous electrolysis

Interventions

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Conservatory treatment

Personalized plantar orthosis

Intervention Type OTHER

Innovate treatment

Personalized plantar orthosis + percutaneous electrolysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Seville

OTHER

Sponsor Role lead

Responsible Party

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Blanca de la Cruz Torres

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Blanca de la Cruz

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Blanca De la Cruz Torres, Dr

Role: CONTACT

666676870

Other Identifiers

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PNE and metatarsalgia

Identifier Type: -

Identifier Source: org_study_id

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