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

• ClinicalTrials.gov Identifier: NCT02498795
• Recruitment Status: Completed
• First Posted: July 15, 2015
• Last Update Posted: December 4, 2020
• Sponsor: Universidad de Zaragoza
• Collaborator: Universidad San Jorge
• Information provided by (Responsible Party): Maria Pilar López Royo, Universidad de Zaragoza

Tracking Information

• First Submitted Date: June 6, 2015
• First Posted Date: July 15, 2015
• Last Update Posted Date: December 4, 2020
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 3, 2017)

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.

• Original Primary Outcome Measures (submitted: July 14, 2015): Change from baseline in functionality at 8 weeks as measured by Visa-p [ Time Frame: 8 weeks ]

Current Secondary Outcome Measures (submitted: January 31, 2020)

• 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
• Quality of life by SF-36 [ Time Frame: 0, 8 and 20 weeks ]
  Health Survey
• Thickness of the tendon, as measured by ultrasound scan [ Time Frame: 0, 8 and 20 weeks ]
  Tendon structure
• Height of the jump [ Time Frame: 0, 8 and 20 weeks ]
  Jump test with a force platform
• Concentric force of the low members [ Time Frame: 0, 8 and 20 weeks ]
  Jump test with a force platform
• Speed of the jump [ Time Frame: 0, 8 and 20 weeks ]
  Jump test with a force platform
• Hypervascularity, as measured by ultrasound scan [ Time Frame: 0, 8 and 20 weeks ]
  Tendon structure
• 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.

Original Secondary Outcome Measures (submitted: July 14, 2015)

• Pain, as measured by Visual Analog Scale [ Time Frame: 0, 8 and 20 weeks ]
• Quality of life [ Time Frame: 0, 8 and 20 weeks ]
  Health Survey
• Thickness of the tendon, as measured by ultrasound scan [ Time Frame: 0, 8 and 20 weeks ]
• Height of the jump [ Time Frame: 0, 8 and 20 weeks ]
• Concentric force of the low members [ Time Frame: 0, 8 and 20 weeks ]
• Speed of the jump [ Time Frame: 0, 8 and 20 weeks ]
• Hypervascularity, as measured by ultrasound scan [ Time Frame: 0, 8 and 20 weeks ]
• Functionality, as measured by Visa-p [ Time Frame: 0 and 20 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparative Research Among 3 Action Protocol in Other to Approach Chronic Patellar Tendinopathy
• Official Title: Comparative Research Among 3 Action Protocol in Other to Approach Chronic Patellar Tendinopathy
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Tendinopathy

Intervention

• 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.
• 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.
• 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.

Study Arms

• 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.

  Intervention: Other: Group of Dry Needling
• 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.

  Intervention: Other: Group of Electrolysis
• 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.
  Intervention: Other: Control Group

• Publications *: López-Royo MP, Gómez-Trullén EM, Ortiz-Lucas M, Galán-Díaz RM, Bataller-Cervero AV, Al-Boloushi Z, Hamam-Alcober Y, Herrero P. Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial. BMJ Open. 2020 Feb 16;10(2):e034304. doi: 10.1136/bmjopen-2019-034304.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 14, 2015): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2, 2020
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02498795
• Other Study ID Numbers: P115/0017
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Maria Pilar López Royo, Universidad de Zaragoza
• Study Sponsor: Universidad de Zaragoza
• Collaborators: Universidad San Jorge

Investigators

• Study Director: Eva Gómez-Trullén, PhD; Universidad de Zaragoza
• Study Director: Pablo Herrero, PhD; Universidad San Jorge

• PRS Account: Universidad de Zaragoza
• Verification Date: December 2020