Evaluation of the Effectiveness of Dry Needling Versus Foam Roller

May 10, 2021 updated by: Fundación Universidad Católica de Valencia San Vicente Mártir

Evaluation of the Effectiveness of Dry Needling Against Foam Roller in the Short Term, Healthy Athletes With Reduced Mobility of the Ankle Joint

To compare the effects of dry needling and Foam roller in myofascial trigger points. Needling has been shown to decrease pain in the short term; however, its effects on muscle force production are unclear. There are differences between dry needling and foam roller after treatment?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: It has been shown that the decrease of the range of motion in the ankle, due to the presence of latent trigger points in the gastro-sole complex, can affect performance, as well as being a predisposing factor to injury. Objective: To compare the effects of Dry Needling and Foam roller in healthy athletes with limited dorsal ankle flexion by the presence of latent trigger points. Material and methods: This is a clinical trial, single-blind experimental study. The sample will have a total of 44 students, volunteers, healthy of the degree of physiotherapy of the the investigator's university (UCV). Participants who meet the inclusion criteria will be randomly assigned in two groups: Group 1 or Dry Needling (N = 22) and Group 2 or Foam Roller (N = 22). The range of motion of ankle will be assessed through the Leg Motion system (Check Your Motion®, Albacete, Spain). Assessed thought Ankle Test (post-intervention and 24 hours later). The reference values to consider the decreased ankle ROM will be <11.5 cm, <35º measured with Easy Angle® digital goniometer (Meloq AB, Sweden) and/or if it has a difference of 1.5 cm between both extremities. Thus, the effect on previous activity performance will be assessed thought the Counter Movement Jump. Data analysis: Once the distribution of the sample is determined, a descriptive analysis of the data will be carried out and an ANOVA of repeated measures. Will be used to compare the data found in the two groups that make up the study taking into account a 95% CI and an error less than 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46021
        • Juan Vicente Mampel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Students of physiotherapy degree of the university
  • All participants who present restriction on active ankle dorsiflexion (<35º).
  • They must be diagnosed through manual therapy of latent PG in the gastro-soleus complex.

Exclusion Criteria:

  • Subjects suffering from belonephobia
  • Pathology of connective tissue
  • Coagulation problems
  • Lymphatic disorders
  • Diabetes
  • Surgical history in the lower limb (last 12 months)
  • Prior treatment with dry needling (last 6 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dry Needling Group
Dry needling will be applied to the myofascial trigger points of the gastrocnemius muscle. With the dry needle (0.3 x 40 mm. Myofib, Toledo, Spain). Thus, insert the needle until you get the first twitch response. Once the first twitch response is obtained, the needle will move about 2-3 mm vertically quickly. Twenty-five insertions without leaving the skin. The approximate frequency of 1 Hz for 25 to 30 seconds.
Procedure: Dry needling
Intervention with deep dry needling on latent myofascial trigger points (MTrPs) in gastrocnemius muscle.
Active Comparator: Foam Roller Group
The myofascial self-release technique with the FR Black Roll PRO (Bottighogen, Switzerland). The subject will move his body in the same direction as the muscle fibers, using his hands to propel and get the roller to slide back and forth. The device will only be applied at the muscular level, avoid the area of the Achilles tendon. It will be repeated on the contralateral leg. A total of three 60-second steps is executed on each leg and a 30-second break between both.
Procedure: Dry needling
Intervention with deep dry needling on latent myofascial trigger points (MTrPs) in gastrocnemius muscle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Range of motion (ROM)
Time Frame: 48 hours
Range of motion (ROM) is a key measurement to help in detecting and diagnosing musculoskeletal deficits, monitoring treatment progression, and guiding the treatment plan. Measurement of ROM is a relevant point and an important item of the joint evaluation process when using any ankle scoring system as part of the ankle and ankle joint evaluation. ROM of ankle joint in load PRE, POST treatment and POST 24 hours after of intervention.
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lunge / Ankle Test Test
Time Frame: 48 hours
he Weight-bearing lunge test (WBLT) or Dorsiflexion Lunge Test (DFT) is used to assess the dorsiflexion range of movement (DROM) at the ankle joint. Participants are instructed to lunge forward until their knee touches the wall (vertical line). The heel is required to remain in contact with the floor at all times. The foot is moved away from the wall to the point where the knee can only make slight contact with the Wall.
48 hours
Counter Movement Jump (CMJ)
Time Frame: 48 hours
The countermovement jump (CMJ) is a simple, practical, valid, and very reliable measure of lower-body power. This suggests that performances in the CMJ are linked with maximal speed, maximal strength, and explosive-strength. When the CMJ is performed using the arm-swing, performances can be ≥10% higher than when they include no arm-swing. Contact mats, force platforms, accelerometers, high-speed cameras, and infrared platforms have all been shown to provide a valid and reliable measure of CMJ performance - though force platforms are considered as the 'gold-standard'.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Universidad Católica de Valencia San Vicente Mártir

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juan Vicente, Fundacion UCV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCV/2019 - 2020/062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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