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Comparative Research Among 3 Action Protocol in Other to Approach Chronic Patellar Tendinopathy

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ClinicalTrials.gov Identifier: NCT02498795
Recruitment Status : Recruiting
First Posted : July 15, 2015
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Universidad San Jorge
Information provided by (Responsible Party):
Maria Pilar López Royo, Universidad de Zaragoza

Brief Summary:
The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional form to the accomplishment of eccentric exercise's program in patients with chronic patellar tendinopathy is more effective than the accomplishment of an additional treatment with dry needling or eccentric exercise's program realized of isolated form.

Condition or disease Intervention/treatment Phase
Tendinopathy Other: Group of Dry Needling Other: Group of Electrolysis Other: Control Group Not Applicable

Detailed Description:

Experimental study randomized with double blind, whose purpose is to compare three protocols in those who apply different protocols of physical therapy to themselves in three groups of intervention with patients with chronic patellar tendinopathy.

There take part in this study young women of both sexes, of Zaragoza and of different sports clubs of entity 18 and 40 years, that they realize of habitual form (minimum 3 times a week) a sport. All of them present chronic patellar tendinopathy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Research Among 3 Action Protocol in Other to Approach Chronic Patellar Tendinopathy
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Active Comparator: Group of Dry Needling

They will receive a treatment of dry needling with ultrasound scan together with a treatment in which they will realize eccentric exercise's program that the patient will have to realize in his domicile.

The needle will get in the relevant zone of treatment. The punction will be realized using the technique of entry - Hong's rapid exit. Three punction will realize in the disabled zone of 3 seconds of duration.

Other: Group of Dry Needling
Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.

Active Comparator: Group of electrolysis

They will receive a treatment of Intratissue Percutaneous Electrolysis with ultrasound scan together with a treatment in which they will realize eccentric exercise's program that the patient will have to realize in his domicile.

The needle will get in the relevant zone of treatment. An intensity of 3 milliampere will be in use, during 3 seconds and one will repeat 3 times.

Other: Group of Electrolysis
Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.

Placebo Comparator: Control Group
They will receive a treatment of punction placebo with ultrasound scan together with a treatment in the one that will realize eccentric exercise's program that the patient will have to realize in his domicile.
Other: Control Group
Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.




Primary Outcome Measures :
  1. Change from baseline in functionality at 8 weeks as measured by Visa-p [ Time Frame: 8 weeks ]
    This scale consists of eight questions, the first six questions of which employ an analogical visual scale in order to assign a score of 0 to 10, where 10 represents the optimum state, for the purpose of quantifying pain and function in different activities, whereas the last two questions assess the level of functionality and ability to perform physical activity.


Secondary Outcome Measures :
  1. Pain, as measured by Visual Analog Scale [ Time Frame: 0, 8 and 20 weeks ]
    Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain

  2. Quality of life [ Time Frame: 0, 8 and 20 weeks ]
    Health Survey

  3. Thickness of the tendon, as measured by ultrasound scan [ Time Frame: 0, 8 and 20 weeks ]
    Tendon structure

  4. Height of the jump [ Time Frame: 0, 8 and 20 weeks ]
    Jump test with a force platform

  5. Concentric force of the low members [ Time Frame: 0, 8 and 20 weeks ]
    Jump test with a force platform

  6. Speed of the jump [ Time Frame: 0, 8 and 20 weeks ]
    Jump test with a force platform

  7. Hypervascularity, as measured by ultrasound scan [ Time Frame: 0, 8 and 20 weeks ]
    Tendon structure

  8. Functionality, as measured by Visa-p [ Time Frame: 0 and 20 weeks ]
    This scale consists of eight questions, the first six questions of which employ an analogical visual scale in order to assign a score of 0 to 10, where 10 represents the optimum state, for the purpose of quantifying pain and function in different activities, whereas the last two questions assess the level of functionality and ability to perform physical activity.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age understood between 18 and 40 years.
  • To practise any sport of habitual form.
  • Patients diagnosed of chronic patellar tendinopathy with a minimum of 3 months of evolution and with stable symptomatology.
  • Pain to the palpation of the tendon in the low pole of the knee and during the training or competition.
  • Punctuation of the questionnaire VISA-P under 80.

Exclusion Criteria:

  • Patient had an operation on the knee affected in the last 6 months.
  • Infiltrations in the knee affected in the last 3 months.
  • Patient who has received pharmacological treatment or physical therapy in the last 48 hours.
  • Pathology with less than 3 months of evolution.
  • To present bilateral chronic tendinopathy.
  • Punctuation of the questionnaire major or equal Visa - p of 80.
  • Inability to apply someone of the techniques of treatment or valuation for absolute or relative contraindication.

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): NCT02498795


Contacts
Contact: Pablo Herrero, PhD 0034 976060100 pherrero@usj.es
Contact: Maria Pilar López-Royo, MD 0034 616102365 mplopez@usj.es

Locations
Spain
Universidad San Jorge Recruiting
Villanueva de Gállego, Zaragoza, Spain, 50830
Contact: Pablo Herrero, PhD    0034 976060100    pherrero@usj.es   
Contact: Maria Pilar López-Royo, MD    616102365    mplopez@usj.es   
Sponsors and Collaborators
Universidad de Zaragoza
Universidad San Jorge
Investigators
Study Director: Eva Gómez-Trullén, PhD Universidad de Zaragoza
Study Director: Pablo Herrero, PhD Universidad San Jorge

Responsible Party: Maria Pilar López Royo, Graduate, Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT02498795     History of Changes
Other Study ID Numbers: P115/0017
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria Pilar López Royo, Universidad de Zaragoza:
Intratissue Percutaneous Electrolysis
Dry needling
Eccentric exercise
Patella

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries