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

December 3, 2020 updated by: Maria Pilar López Royo, Universidad de Zaragoza
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.

Study Overview

Status

Status

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

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

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

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 (Actual)

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.
50

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 Locations

  • Spain
    • Zaragoza
      • Villanueva de Gállego, Zaragoza, Spain, 50830
        • Universidad San Jorge

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Triple

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: 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.

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
Measure Description
Time Frame
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.
8 weeks

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad San Jorge

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

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 (Actual)

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.
January 1, 2019

Primary Completion (Actual)

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.
December 31, 2019

Study Completion (Actual)

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.
May 2, 2020

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).
June 6, 2015

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.
July 14, 2015

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.
July 15, 2015

Study Record Updates

Last Update Posted (Actual)

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.
December 4, 2020

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.
December 3, 2020

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.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • P115/0017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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