Percutaneous Needle Electrolysis on Metatarsalgia

Sponsor
University of Seville (Other)
Overall Status
Recruiting
CT.gov ID
NCT05262972
Collaborator
(none)
30
1
2
7
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Conservatory treatment
  • Other: Innovate treatment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
APPLICATION OF ULTRASOUND-GUIDED PERCUTANEOUS ELECTROLYSIS IN THE PAIN OF THE SECOND METATARSOPHALANGEAL JOINT IN ADULT WOMEN
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Quality of life [1 month]

    Foot Health Status Questionnaire

  2. Subjetive level of pain [1 month]

    Intensity of subjective pain in the injured structure (0, no pain; 10, worse pain)

  3. level of pain at palpation [1 month]

    Intensity of pain on palpation in the injured structure (0, no pain; 10, worse pain)

  4. Distribution of plantar pressures [1 month]

    Podiatric platform (pressure percentage 0-100%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blanca de la Cruz Seville Spain

Sponsors and Collaborators

  • University of Seville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Blanca de la Cruz Torres, Director, University of Seville
ClinicalTrials.gov Identifier:
NCT05262972
Other Study ID Numbers:
  • PNE and metatarsalgia
First Posted:
Mar 2, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022