Percutaneous Needle Electrolysis on Metatarsalgia

Not Applicable

Recruiting

• Conditions: Metatarsalgia
• Interventions: Other: Innovate treatment; Other: Conservatory treatment

• Registration Number: NCT05262972
• Lead Sponsor: University of Seville

Brief 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. 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

Not available

Study Timeline

• Study First Submitted: 2022-02-19
• Study First Submitted QC: 2022-02-19
• Study Start: 2022-03-01
• Primary Completion: 2022-03-01
• Study First Posted: 2022-03-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Innovate treatment	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 I	Conservatory treatment	The subject will obtain a conservative treatment for this type of pathology consisting of the development of a personalized plantar orthosis

Primary Outcome Measures

Name	Time	Method
Distribution of plantar pressures	1 month	Podiatric platform (pressure percentage 0-100%)
level of pain at palpation	1 month	Intensity of pain on palpation in the injured structure (0, no pain; 10, worse pain)
Quality of life	1 month	Foot Health Status Questionnaire
Subjetive level of pain	1 month	Intensity of subjective pain in the injured structure (0, no pain; 10, worse pain)

Trial Locations

Locations (1)

Blanca de la Cruz; 🇪🇸 Seville, Spain