Dry Needling Effectiveness of Patients on Break Anterior Cruciate Ligament. (ACL)

March 1, 2016 updated by: Jorge Velázquez Saornil, European University Spain

Dry Needling Effectiveness of Patients on Break Anterior Cruciate Ligament. Single-Blind Randomized Clinical Trial.

We will conduct a randomized clinical trial observing forty patients divided into two groups: one group composed of twenty individuals undergoing surgery for ruptured ACL, which perform dry needling of myofascial trigger (PGM) point of the vastus muscle and then perform techniques proprioception (group a); and twenty patients not be treated with dry needling after ACL surgery, using only proprioceptive exercises to the joint (group B).

Study Overview

Status

Status

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

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

It carries out a last fifteen days ECA surgical reconstruction of the anterior cruciate ligament. Twenty individuals in a group to be subjected to a technique of physiotherapy, dry needling were included. (Group A). Another group of twenty patients treated with conservative treatment performed a stability exercises and proprioception (Group B). Forty-six patients will be examined s. None had been previously operated by joint instability and all subjects were previously subjected to a diagnostic study by nuclear magnetic resonance before surgery and the diagnosis was confirmed by additional diagnostic testing. All patients will be evaluated by a physical therapist and Myofascial Trigger Point (PGM) of the vastus muscle will be evaluated.

patients using the following variables are evaluated:

  • Pain: Visual Analog Scale (VAS) was used.
  • Stiffness and physical function using the WOMAC scale (The Western Ontario and McMaster Universities Arthritis Index.).
  • Range of motion of the knee joint: Scale ROM.
  • Muscular strength, balance and propiocepción: Star Excursion by Balance Scale Test.

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 (Anticipated)

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.
40

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • Jorge Velázquez Saornil
        • Contact:
          • Jorge Velázquez, Mr
        • Contact:
        • Principal Investigator:
          • Jorge Velázquez, Mr
        • Sub-Investigator:
          • Beatriz Ruiz, Mrs
        • Sub-Investigator:
          • César Calvo, Mr

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over eighteen and anatomically mature surgically break LCA and valued above using MRI and functional tests to confirm the rupture of the ligament.

Exclusion Criteria:

  • Patients who did not reach 18 years of age and those over 55,
  • postoperative complications
  • cause myofascial or neuropathic pain in the lower limb, as lumba-sacral radiculopathy, neuropraxia, neurotmesis, axonotmesis or meralgia paresthetica;
  • fibromyalgia.
  • hypothyroidism
  • iron deficiencies and patients who had a fear of needles (fear of needles).
  • Lower limb differences.

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: Single

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.
Active Comparator: dry needling
Dry needling on the vastus is performed in patients undergoing ACL fortnight after the intervention and then evaluated. REL dry needling while supplies last twenty insertions before treatment, at midnight, a week and five weeks.
Device: Dry needling
dry needling Travell and Simons
Active Comparator: Stability and propioception
Proprioception and stability exercises in patients undergoing ACL fortnight after the intervention and then evaluates performed before treatment, at midnight, a week and five weeks.
Other: Stability and propioception
Start excursion balance test, WOMAC; ROM, EVA.

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
Time Frame
Degree range of motion (ROM)
Time Frame: 24 hours
24 hours
Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: 24 hours
24 hours
Pain scores visual analog scale (EVA)
Time Frame: 24 hours
24 hours
Scores of STAR BALANCE TEST
Time Frame: 24
24

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
Time Frame
Degree range of motion (ROM)
Time Frame: 1 week
1 week
Degree range of motion (ROM)
Time Frame: 5 weeks
5 weeks
Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: 1 week
1 week
Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: 5 weeks
5 weeks
Pain scores visual analog scale (EVA)
Time Frame: 1 week
1 week
Pain scores visual analog scale (EVA)
Time Frame: 5 weeks
5 weeks
Scores STAR BALANCE TEST
Time Frame: 1week
1week
Scores STAR BALANCE TEST
Time Frame: 5 weeks
5 weeks

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.
European University Spain

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: Jorge Velázquez, Sr, European University

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

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.
February 1, 2016

Primary Completion (Anticipated)

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.
June 1, 2016

Study Completion (Anticipated)

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.
September 1, 2016

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).
February 26, 2016

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.
March 1, 2016

First Posted (Estimate)

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.
March 4, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
March 4, 2016

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.
March 1, 2016

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.
March 1, 2016

More Information

Terms related to this study

Keywords

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.
  • European University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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