Neuromodulation vs. Electrolysis in Plantar Fasciitis

Sponsor

Universidad Europea de Madrid (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05826301

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of the present study will be the implementation of two protocols in plantar fasciitis individuals: a) percutaneous neuromodulation, b) percutaneous electrolysis in plantar fascia. Authors hypothesized that percutaneous neuromodulation may have benefits in: pain, quality of life, muscular structure.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fascitis	Other: Percutaneous neuromodulation in tibial nerve Other: Percutaneous electrolysis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Percutaneous Neuromodulation in Tibial Nerve vs. Electrolysis in Plantar Fasciitis Subjects

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Percutaneous neuromodulation in tibial nerve Specifically, the procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve. 2 times per week	Other: Percutaneous neuromodulation in tibial nerve The procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve.
Active Comparator: Percutaneous electrolysis The procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds. 1 time per week	Other: Percutaneous electrolysis The procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds. 1 time per weeK

Arm

Intervention/Treatment

Experimental: Percutaneous neuromodulation in tibial nerve

Specifically, the procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve. 2 times per week

Other: Percutaneous neuromodulation in tibial nerve

The procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve.

Active Comparator: Percutaneous electrolysis

The procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds. 1 time per week

Other: Percutaneous electrolysis

The procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds. 1 time per weeK

Outcome Measures

Primary Outcome Measures

Pain intensity [Pre intervention]
visual analoge scale (VAS)
Pain intensity [immediately post intervention]
visual analogue scale (VAS)
Pain intensity [at 4 weeks]
visual analogue scale (VAS)

Secondary Outcome Measures

quality of life perception [Pre intervention]
SF-36 questionnaire
quality of life perception [immediately post intervention]
SF-36 questionnaire
quality of life perception [at 4 weeks]
SF-36 questionnaire
Ultrasonography of extrinsic foot muscles [Pre intervention]
Ultrasound imaging of the thickness and cross-sectional area of the tibiais
Ultrasonography of extrinsic foot muscles [immediately post intervention]
Ultrasound imaging of the thickness and cross-sectional area of the tibiais
Ultrasonography of extrinsic foot muscles [at 4 weeks]
Ultrasound imaging of the thickness and cross-sectional area of the tibiais

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patiens with plantar fasciitis

Exclusion Criteria:

Lower limb disturbances
Sistemic diseases
Not involved in other drug or manual therapy interventions
Infections

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universidad Europea de Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Universidad Europea de Madrid

ClinicalTrials.gov Identifier:

NCT05826301

Other Study ID Numbers:

AA-11/8/HMC/DADCI

First Posted:

Apr 24, 2023

Last Update Posted:

Apr 24, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universidad Europea de Madrid

Additional relevant MeSH terms:

Fasciitis

Fasciitis, Plantar

Study Results

No Results Posted as of Apr 24, 2023