Back to resultsComparative Research Among 3 Action Protocol in Other to Approach Chronic Patellar Tendinopathy
Primary Purpose
Tendinopathy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Group of Dry Needling
Group of Electrolysis
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy focused on measuring Intratissue Percutaneous Electrolysis, Dry needling, Eccentric exercise, Patella
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.
Sites / Locations
- Universidad San Jorge
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Group of Dry Needling
Group of electrolysis
Control Group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Quality of life by SF-36
Health Survey
Thickness of the tendon, as measured by ultrasound scan
Tendon structure
Height of the jump
Jump test with a force platform
Concentric force of the low members
Jump test with a force platform
Speed of the jump
Jump test with a force platform
Hypervascularity, as measured by ultrasound scan
Tendon structure
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.
Full Information
NCT ID
NCT02498795
First Posted
June 6, 2015
Last Updated
December 3, 2020
Sponsor
Universidad de Zaragoza
Collaborators
Universidad San Jorge
1. Study Identification
Unique Protocol Identification Number
NCT02498795
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
May 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
Collaborators
Universidad San Jorge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Intratissue Percutaneous Electrolysis, Dry needling, Eccentric exercise, Patella
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group of Dry Needling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group of electrolysis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Group of Dry Needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group of Electrolysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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 Measure Information:
Title
Change from baseline in functionality at 8 weeks as measured by Visa-p
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pain, as measured by Visual Analog Scale
Description
Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain
Time Frame
0, 8 and 20 weeks
Title
Quality of life by SF-36
Description
Health Survey
Time Frame
0, 8 and 20 weeks
Title
Thickness of the tendon, as measured by ultrasound scan
Description
Tendon structure
Time Frame
0, 8 and 20 weeks
Title
Height of the jump
Description
Jump test with a force platform
Time Frame
0, 8 and 20 weeks
Title
Concentric force of the low members
Description
Jump test with a force platform
Time Frame
0, 8 and 20 weeks
Title
Speed of the jump
Description
Jump test with a force platform
Time Frame
0, 8 and 20 weeks
Title
Hypervascularity, as measured by ultrasound scan
Description
Tendon structure
Time Frame
0, 8 and 20 weeks
Title
Functionality, as measured by Visa-p
Description
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.
Time Frame
0 and 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Gómez-Trullén, PhD
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pablo Herrero, PhD
Organizational Affiliation
Universidad San Jorge
Official's Role
Study Director
Facility Information:
Facility Name
Universidad San Jorge
City
Villanueva de Gállego
State/Province
Zaragoza
ZIP/Postal Code
50830
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33556350
Citation
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.
Results Reference
derived
PubMed Identifier
32066608
Citation
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.
Results Reference
derived
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Comparative Research Among 3 Action Protocol in Other to Approach Chronic Patellar Tendinopathy
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