Post-needling Soreness After Internal Gastrocnemius Muscle Treatment

NCT04060576 | Completed

• 1 other identifier: CEIM/HU/2019/01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

Mechanical hyperalgesia areas, also known as myofascial trigger points, are treated by manual therapy or invasive technics. Dry needling achieves an improvement of the symptomatology in 70% of the subjects, being the acute patients the most benefited. However, bruising, bleeding, pain during treatment or post-needling soreness. Plantar fasciitis is the most common cause of interior heel pain, affects approximately 10% of the general population and is one of the most benefited pathologies in the long term by the application of dry needling The gauge of the needle chosen for the treatment can influence post-needling soreness intensity and pressure pain threshold. Objective To evaluate the relation between post-needling soreness intensity and needle diameter on the treatment of the most hyperalgesic point of the internal gastrocnemius. Hypothesis Post-needling soreness intensity and pressure pain threshold depend on needle diameter applied in the treatment of the most hyperalgesic point of the internal gastrocnemius.

Conditions

Heel Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• Post-needling soreness intensity

  The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.

  Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.

• Pressure Pain Threshold

  The PPT serves to determine the sensitivity of hiperalgesic focus. The investigators will done it with one algometer. A lower threshold is a worse result. A higher threshold is a better result.

  Change from Baseline Pressure Pain Threshold at 72 hours

Study Arms (3)

Group A treated with a 16-gauge needle

EXPERIMENTAL

Group A is intervened on the gastrocnemius muscle with a 16-gauge needle.

Procedure: Dry needling treatment with a thinner needle

Group B treated with a 25-gauge needle

EXPERIMENTAL

Group B is intervened on the gastrocnemius muscle with a 25-gauge needle.

Procedure: Dry needling treatment with a medium-sized needle

Group C treated with a 32-gauge needle

EXPERIMENTAL

Group C is intervened on the gastrocnemius muscle with a 32-gauge needle.

Procedure: Dry needling treatment with a thickest needle

Interventions

Dry needling treatment with a thinner needle PROCEDURE

We will make an application with the dry needling technique with a fine needle on the myofascial trigger points of the gastrocnemius muscle.

Group A treated with a 16-gauge needle

Dry needling treatment with a medium-sized needle PROCEDURE

We will make an application with the dry needling technique with a medium-sized needle on the myofascial trigger points of the gastrocnemius muscle.

Group B treated with a 25-gauge needle

Dry needling treatment with a thickest needle PROCEDURE

We will make an application with the dry needling technique with the thickest needle on the myofascial trigger points of the gastrocnemius muscle.

Group C treated with a 32-gauge needle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65.
• Plantar Fasciitis diagnosis.
• Presence of hyperalgesic area in the internal gastrocnemius.

You may not qualify if:

• Belenophobia
• Hypothyroidism Presence of hyperalgesic area in the internal gastrocnemius - Diabetes
• Lymphedema o lymphatic surgery Muscle diseases
• Anticoagulant consumption Knee or ankle surgery
• Analgesic consumption during the study

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (2)

Instituto Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28807, Spain

Location

Grupo Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28871, Spain

Location

Study Officials

• Tomas Gallego-Izquierdo, Dr

  Alcala University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Daniel Pecos Martín

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 19, 2019
• Study Start: September 8, 2019
• Primary Completion: December 16, 2019
• Study Completion: January 20, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

ES (2)