NCT05262972

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

Same day

First QC Date

February 19, 2022

Last Update Submit

November 1, 2022

Conditions

Metatarsalgia

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Group I

EXPERIMENTAL

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

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

Other: Innovate treatment

Interventions

Conservatory treatmentOTHER

Personalized plantar orthosis

Group I
Innovate treatmentOTHER

Personalized plantar orthosis + percutaneous electrolysis

Group II

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis pathology is much more frequent in women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blanca de la Cruz

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Metatarsalgia

Condition Hierarchy (Ancestors)

Foot DiseasesMusculoskeletal DiseasesJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Blanca De la Cruz Torres, Dr

CONTACT

666676870bcruz@us.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 2, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2022

Study Completion

September 30, 2023

Last Updated

November 2, 2022

Record last verified: 2022-11

Locations

ES(1)