Percutaneous Needle Electrolysis on Metatarsalgia

Metatarsalgia Clinical Trial

Official title:

APPLICATION OF ULTRASOUND-GUIDED PERCUTANEOUS ELECTROLYSIS IN THE PAIN OF THE SECOND METATARSOPHALANGEAL JOINT IN ADULT WOMEN

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262972
• Other study ID #: PNE and metatarsalgia
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2022
• Source: University of Seville
• Contact: Blanca De la Cruz Torres, Dr
• Phone: 666676870
• Email: bcruz[@]us.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metatarsalgia

Intervention

Other:
• Conservatory treatment
Personalized plantar orthosis
• Innovate treatment
Personalized plantar orthosis + percutaneous electrolysis

Locations

Country	Name	City	State
Spain	Blanca de la Cruz	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

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