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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699411
Recruitment Status : Unknown
Verified March 2016 by Jorge Velázquez Saornil, European University Spain.
Recruitment status was:  Recruiting
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Jorge Velázquez Saornil, European University Spain

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Device: Dry needling Other: Stability and propioception Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Dry Needling Effectiveness of Patients on Break Anterior Cruciate Ligament. Single-Blind Randomized Clinical Trial.
Study Start Date : February 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Degree range of motion (ROM) [ Time Frame: 24 hours ]
  2. Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 24 hours ]
  3. Pain scores visual analog scale (EVA) [ Time Frame: 24 hours ]
  4. Scores of STAR BALANCE TEST [ Time Frame: 24 ]

Secondary Outcome Measures :
  1. Degree range of motion (ROM) [ Time Frame: 1 week ]
  2. Degree range of motion (ROM) [ Time Frame: 5 weeks ]
  3. Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 1 week ]
  4. Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 5 weeks ]
  5. Pain scores visual analog scale (EVA) [ Time Frame: 1 week ]
  6. Pain scores visual analog scale (EVA) [ Time Frame: 5 weeks ]
  7. Scores STAR BALANCE TEST [ Time Frame: 1week ]
  8. Scores STAR BALANCE TEST [ Time Frame: 5 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699411


Contacts
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Contact: Jorge Velázquez, sr +34655909940 jorgevelasa@yahoo.es

Locations
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Spain
Jorge Velázquez Saornil Recruiting
Madrid, Spain
Contact: Jorge Velázquez, Mr         
Contact: Jorge Velázquez       jorgevelasa@yahoo.es   
Principal Investigator: Jorge Velázquez, Mr         
Sub-Investigator: Beatriz Ruiz, Mrs         
Sub-Investigator: César Calvo, Mr         
Sponsors and Collaborators
European University Spain
Investigators
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Principal Investigator: Jorge Velázquez, Sr European University
Publications:

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Responsible Party: Jorge Velázquez Saornil, Physiotherapist, European University Spain
ClinicalTrials.gov Identifier: NCT02699411    
Other Study ID Numbers: European University
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jorge Velázquez Saornil, European University Spain:
ligament anterior cruciate , dry needling, physioterapy, propioception, knee arthroplasty, vastus medialis.