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

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: Completed
• Conditions: Tendinopathy
• Intervention / Treatment: Other: Group of Dry Needling; Other: Group of Electrolysis; Other: Control Group

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in functionality at 8 weeks as measured by Visa-p	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

Outcome Measure	Measure Description	Time Frame
Pain, as measured by Visual Analog Scale	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	Health Survey	0, 8 and 20 weeks
Thickness of the tendon, as measured by ultrasound scan	Tendon structure	0, 8 and 20 weeks
Height of the jump	Jump test with a force platform	0, 8 and 20 weeks
Concentric force of the low members	Jump test with a force platform	0, 8 and 20 weeks
Speed of the jump	Jump test with a force platform	0, 8 and 20 weeks
Hypervascularity, as measured by ultrasound scan	Tendon structure	0, 8 and 20 weeks
Functionality, as measured by Visa-p	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

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

Publications and helpful links

General Publications

• Lopez-Royo MP, Rios-Diaz J, Galan-Diaz RM, Herrero P, Gomez-Trullen EM. A Comparative Study of Treatment Interventions for Patellar Tendinopathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):967-975. doi: 10.1016/j.apmr.2021.01.073. Epub 2021 Feb 6.
• Lopez-Royo MP, Gomez-Trullen EM, Ortiz-Lucas M, Galan-Diaz 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): May 2, 2020

Study Registration Dates

• First Submitted: June 6, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Dry needling; Eccentric exercise; Patella; Intratissue Percutaneous Electrolysis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID 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