- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04968236
Dry Needling Versus Conservative Treatment in the Rectus Femoris Muscle Approach.
Application of the Deep Versus Superficial Dry Needling and Stretching Technique in the Treatment of the Quadriceps Rectus Femoris Muscle.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Madrid
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Alcalá De Henares, Madrid, Spain, 28805
- Centro Investigación Fisioterapia y Dolor
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Alcalá de Henares, Madrid, Spain, 28805
- Physiotherapy and Pain Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women between 18 and 65 years old.
- To have at least 70º of knee flexion.
- Be aware of and accept the study criteria (informed consent).
- Healthy subjects, without previous hip or knee pathology or involved musculature.
Exclusion Criteria:
- To have pain.
- Having pain in the quadriceps or hip at the time of the study.
- Currently following physiotherapy or analgesic treatment.
- Belenophobia (fear of needles).
- Recent surgery or trauma in the area.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deep dry needling
With the subject lying supine, we will first locate a latent myofascial trigger point in the rectus femoris muscle.Subsequently, we will apply a deep dry needling technique to the latent trigger point and make 10-12 incisions.
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In-and-out into different directions technique to encounter sensitive spots in an MTrP region.
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Experimental: Superficial dry needling
With the subject lying supine, we will first locate a latent myofascial trigger point in the rectus femoris muscle.Subsequently, we will apply a superficial dry needling technique to the latent trigger point.
Once the needle is placed in the subcutaneous cellular tissue, we manipulate the needle by twisting it until an unpleasant response is provoked.
We keep the needle for 5 minutes
|
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.
|
Experimental: Passive muscle stretching
With the patient positioned in the supine position, the pelvis stabilized with a strap and the lower extremity where we are going to apply the rectus femoris muscle stretch placed outside the table, we perform a passive stretching technique, increasing hip extension and knee flexion until the patient feels the tension.
The position is held for 60 seconds.
|
Type of stretching in which you stay in one position for a set time.
In this case, hip extension and knee flexion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee joint range
Time Frame: Change from baseline at 7 days
|
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
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Muscle strength
Time Frame: Change from baseline at 7 days
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure Pain Threshold (PPT)
Time Frame: Change from baseline at 7 days
|
An algometer Wagner FPI 10-WA will be used to determine the PPT in rectus femoris trigger points
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Change from baseline at 7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 06/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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