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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04968236
Other study ID # 06/2014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2021
Est. completion date February 5, 2024

Study information

Verified date February 2024
Source University of Alcala
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In recent years, dry needling techniques have become widespread in the field of musculoskeletal pain treatment. Specifically, the management of myofascial trigger points has been the focus of these techniques. One of the objectives has been to improve the flexibility of those muscles that, due to the presence of myofascial trigger points, had a decrease in this parameter. This study aims to determine whether the application of a dry needling technique is more effective than analytical stretching of the muscle.


Description:

Hypothesis of the study Deep dry needling of latent trigger points of the rectus femoris produces greater effects on flexibility, strength and pain than superficial dry needling or stretching. - Overall objective: To compare the differences that occur in flexibility, strength and pain threshold to pressure after the application of deep dry needling, superficial dry needling and stretching on latent trigger points of the rectus femoris. - Specific objectives To determine the changes produced by deep dry needling on flexibility, strength and pain threshold to pressure. To determine the changes produced by superficial dry needling on flexibility, strength and pain threshold to pressure. To determine the changes in flexibility, strength and pain threshold to pressure produced by conventional assisted stretching. To check if the changes remain after 7 days of the application of the techniques. To assess the inter-rater reliability of the Goniometer APP in the study sample.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date February 5, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Men and women between 18 and 65 years old. 2. To have at least 70º of knee flexion. 3. Be aware of and accept the study criteria (informed consent). 4. Healthy subjects, without previous hip or knee pathology or involved musculature. Exclusion Criteria: 1. To have pain. 2. Having pain in the quadriceps or hip at the time of the study. 3. Currently following physiotherapy or analgesic treatment. 4. Belenophobia (fear of needles). 5. Recent surgery or trauma in the area. 6. Pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Deep Dry Needling
In-and-out into different directions technique to encounter sensitive spots in an MTrP region.
Superficial Dry Needling
This technique involves inserting a needle at a depth that is into the subcutaneous tissue and may be combined with manipulation of the needle while in situ.
passive stretching
Type of stretching in which you stay in one position for a set time. In this case, hip extension and knee flexion.

Locations

Country Name City State
Spain Centro Investigación Fisioterapia y Dolor Alcalá De Henares Madrid
Spain Physiotherapy and Pain Institute Alcalá de Henares Madrid

Sponsors (1)

Lead Sponsor Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee joint range Knee flexion motion assessment by using the Goniometer APP, which is a digital goniometer that has proven its reliability and validity.The overall concordance coefficient has shown very good to excellent with active measurements (range, 0.60-0.97). Change from baseline at 7 days
Primary Muscle strength Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of flexion of knee. Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in flexion of the knee, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98). Change from baseline at 7 days
Secondary Pressure Pain Threshold (PPT) An algometer Wagner FPI 10-WA will be used to determine the PPT in rectus femoris trigger points Change from baseline at 7 days
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