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OpenTrials
Completed

NCT Number: NCT05826301

Neuromodulation vs. Electrolysis in Plantar Fasciitis

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.

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Key information

Conditions

Plantar Fascitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UEM, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patiens with plantar fasciitis

Exclusion criteria

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

Treatment and study plan

Percutaneous neuromodulation in tibial nerve

Other

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.

Percutaneous electrolysis

Other

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

Primary outcomes

  1. Pain intensity

    Time frame: Pre intervention

    visual analoge scale (VAS)

  2. Pain intensity

    Time frame: immediately post intervention

    visual analogue scale (VAS)

  3. Pain intensity

    Time frame: at 4 weeks

    visual analogue scale (VAS)

Secondary outcomes

  1. quality of life perception

    Time frame: Pre intervention

    SF-36 questionnaire

  2. quality of life perception

    Time frame: immediately post intervention

    SF-36 questionnaire

  3. quality of life perception

    Time frame: at 4 weeks

    SF-36 questionnaire

  4. Ultrasonography of extrinsic foot muscles

    Time frame: Pre intervention

    Ultrasound imaging of the thickness and cross-sectional area of the tibiais

  5. Ultrasonography of extrinsic foot muscles

    Time frame: immediately post intervention

    Ultrasound imaging of the thickness and cross-sectional area of the tibiais

  6. Ultrasonography of extrinsic foot muscles

    Time frame: at 4 weeks

    Ultrasound imaging of the thickness and cross-sectional area of the tibiais

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 24, 2023
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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