Percutaneous Needle Electrolysis on Metatarsalgia
Primary Purpose
Metatarsalgia
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conservatory treatment
Innovate treatment
Sponsored by
About this trial
This is an interventional treatment trial for Metatarsalgia
Eligibility Criteria
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.
Sites / Locations
- Blanca de la CruzRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I
Group II
Arm Description
The subject will obtain a conservative treatment for this type of pathology consisting of the development of a personalized plantar orthosis
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
Outcomes
Primary Outcome Measures
Quality of life
Foot Health Status Questionnaire
Subjetive level of pain
Intensity of subjective pain in the injured structure (0, no pain; 10, worse pain)
level of pain at palpation
Intensity of pain on palpation in the injured structure (0, no pain; 10, worse pain)
Distribution of plantar pressures
Podiatric platform (pressure percentage 0-100%)
Secondary Outcome Measures
Full Information
NCT ID
NCT05262972
First Posted
February 19, 2022
Last Updated
November 1, 2022
Sponsor
University of Seville
1. Study Identification
Unique Protocol Identification Number
NCT05262972
Brief Title
Percutaneous Needle Electrolysis on Metatarsalgia
Official Title
APPLICATION OF ULTRASOUND-GUIDED PERCUTANEOUS ELECTROLYSIS IN THE PAIN OF THE SECOND METATARSOPHALANGEAL JOINT IN ADULT WOMEN
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metatarsalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
The subject will obtain a conservative treatment for this type of pathology consisting of the development of a personalized plantar orthosis
Arm Title
Group II
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Conservatory treatment
Intervention Description
Personalized plantar orthosis
Intervention Type
Other
Intervention Name(s)
Innovate treatment
Intervention Description
Personalized plantar orthosis + percutaneous electrolysis
Primary Outcome Measure Information:
Title
Quality of life
Description
Foot Health Status Questionnaire
Time Frame
1 month
Title
Subjetive level of pain
Description
Intensity of subjective pain in the injured structure (0, no pain; 10, worse pain)
Time Frame
1 month
Title
level of pain at palpation
Description
Intensity of pain on palpation in the injured structure (0, no pain; 10, worse pain)
Time Frame
1 month
Title
Distribution of plantar pressures
Description
Podiatric platform (pressure percentage 0-100%)
Time Frame
1 month
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
This pathology is much more frequent in women.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blanca De la Cruz Torres, Dr
Phone
666676870
Email
bcruz@us.es
Facility Information:
Facility Name
Blanca de la Cruz
City
Seville
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Percutaneous Needle Electrolysis on Metatarsalgia
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