Clincosm LogoSign in Get a demo

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

Sponsor
European University Spain (Other)
Overall Status
Unknown status
CT.gov ID
NCT02699411
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Dry needling
  • Other: Stability and propioception
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Sep 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Degree range of motion (ROM) [24 hours]

  2. Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) [24 hours]

  3. Pain scores visual analog scale (EVA) [24 hours]

  4. Scores of STAR BALANCE TEST [24]

Secondary Outcome Measures

  1. Degree range of motion (ROM) [1 week]

  2. Degree range of motion (ROM) [5 weeks]

  3. Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) [1 week]

  4. Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) [5 weeks]

  5. Pain scores visual analog scale (EVA) [1 week]

  6. Pain scores visual analog scale (EVA) [5 weeks]

  7. Scores STAR BALANCE TEST [1week]

  8. Scores STAR BALANCE TEST [5 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jorge Velázquez Saornil Madrid Spain

Sponsors and Collaborators

  • European University Spain

Investigators

  • Principal Investigator: Jorge Velázquez, Sr, European University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jorge Velázquez Saornil, Physiotherapist, European University Spain
ClinicalTrials.gov Identifier:
NCT02699411
Other Study ID Numbers:
  • European University
First Posted:
Mar 4, 2016
Last Update Posted:
Mar 4, 2016
Last Verified:
Mar 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Jorge Velázquez Saornil, Physiotherapist, European University Spain
ligament anterior cruciate , dry needling, physioterapy, propioception, knee arthroplasty, vastus medialis.

Study Results

No Results Posted as of Mar 4, 2016