Percutaneous Needle Electrolysis on Metatarsalgia

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.

Study Overview

• Status: Recruiting
• Conditions: Metatarsalgia
• Intervention / Treatment: Other: Conservatory treatment; Other: Innovate treatment

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Blanca De la Cruz Torres, Dr; Phone Number: 666676870; Email: bcruz@us.es

Study Locations

• Spain
  • Seville, Spain
    • Recruiting
    • Blanca de la Cruz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; The subject will obtain a conservative treatment for this type of pathology consisting of the development of a personalized plantar orthosis	Other: Conservatory treatment; Personalized plantar orthosis
Experimental: 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	Other: Innovate treatment; Personalized plantar orthosis + percutaneous electrolysis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 1, 2022
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: February 19, 2022
• First Submitted That Met QC Criteria: February 19, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Metatarsalgia
• Other Study ID Numbers: PNE and metatarsalgia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No