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Trial registered on ANZCTR


Registration number
ACTRN12616000982415
Ethics application status
Approved
Date submitted
30/04/2016
Date registered
26/07/2016
Date last updated
26/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison between pain education and tendinopathy education both combined with a eccentric exercises program in sports players with chronic patellar tendinopathy.
Scientific title
Comparison between pain education and tendinopathy education both combined with a eccentric exercises program for the reduction of pain and the improvement of life quality in sports players with chronic patellar tendinopathy.
Secondary ID [1] 288827 0
None
Universal Trial Number (UTN)
U1111-1179-6217
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Patellar tendinopathy 298103 0
Pain 298104 0
Condition category
Condition code
Musculoskeletal 298270 298270 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298271 298271 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Program with explanation of pain (theoretical class about the pain, neuroscience, physiology of pain and how it works the pain) combined with eccentric exercise in a 25 degrees decline board which the participants have to perform for 3 weeks at home.
Arm 2: Program with explanation of tendinopathy (theoretical class about the physiology of the tendon, the function of the patellar tendon, what is the tendinopathy and how it works) combined with eccentric exercise in a 25degrees decline board which the participants have to perform for 3 weeks at home..
Both groups made with sports players from athleticism, volleyball and basketball with chronic patellar tendinopathy.
The programs of explanation consist in a group theoretical 1 hour class with the support of a PowerPoint.
The programs of eccentric training consist in a first group class of 30 minutes for explain the exercises and the progress of them, and then the participants do the exercises twice a day during 3 weeks with the 25 degrees decline board at home. The exercise consist of 3 sets of 15 repetitions performed during 15 minutes twice daily of a single leg squat stand on the 25 degrees declined board while performing the exercise.
The intervention consist in 4 sessions: session 1 complete the test and explanation of pain/tendinopathy, session 2 explanation of the exercise and start of home exercises completed within 1 week of session 1, session 3 occurs three weeks following session 2, and the participants complete the final test, session 4 occurs 1 month following session 3, and the participants complete the monitoring test.
All the interventions are executed by experienced physical therapists in a sports center.
In order to monitor the adherence when the patients complete the exercises they have to send an okey sign in a message to the physical therapist.
Intervention code [1] 294282 0
Rehabilitation
Intervention code [2] 294761 0
Treatment: Other
Comparator / control treatment
The program with explanation of pain combined with eccentric exercise will act as the control.
Control group
Active

Outcomes
Primary outcome [1] 297757 0
Primary outcome 1: Found the changes in the pain in chronic patellar tendinopathy after the intervention, assessed using MPQ-SV questionaire short version with a VAS.

Timepoint [1] 297757 0
Timepoint: Baseline and when the intervention finishes and 1 month after the intervention commencement.
Primary outcome [2] 297758 0
Primary outcome 2: Found the changes in the quality of life in chronic patellar tendinopathy after the intervention, assessed using SF-36 questionnaire.
Timepoint [2] 297758 0
Timepoint: Baseline, and when the intervention finishes and 1 month after the intervention commencement.
Secondary outcome [1] 322142 0
Secondary outcome 1: Amount of change, in case that it happened, in pain in sport players with chronic patellar tendinopathy after the intervention assessed by MPQ-SV questionnaire short version with a VAS..
Timepoint [1] 322142 0
Timepoint: when the intervention finishes and 1 month after the intervention commencement.
Secondary outcome [2] 322143 0
Secondary outcome 2: Amount of change in the quality of life, in case that it happened, in sports players with chronic patellar tendinopathy, assessed by SF-36 questionnaire.
Timepoint [2] 322143 0
Timepoint: when the intervention finishes and 1 month after the intervention commencement.
Secondary outcome [3] 322145 0
Secondary outcome 4: (composite secondary outcome) Investigate what are the factors (changes in the understanding of pain, changes in the tendon, changes in the understanding of the pathology) that can influence the results after the application of this intervention. Each component will be assessed by the SF-36 and MPQ-SV short version questionnaires.
Timepoint [3] 322145 0
Timepoint: Baseline and when the intervention finishes.
Secondary outcome [4] 322146 0
Secondary outcome 5: Identify which aspects of quality of life of the sport players with chronic patellar tendinopathy are the most affected. This outcome will be assessed using the SF-36 test in Spanish Version.
Timepoint [4] 322146 0
Timepoint: when the intervention finishes.

Eligibility
Key inclusion criteria
Minimum of exercise that each participant must be completing in a normal week: 3 trainings of his/her sport (athletics, basketball, volleyball) per week of 45 minutes each one, chronic patellar tendinopathy, no meniscus injury or muscular injury or articular injury and no pharmacological, medical or physical therapy treatment during the intervention.
Minimum age
18 Years
Maximum age
46 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 3 trainings/week of less than 45 minutes each one, no chronic patellar tendinopathy, with meniscus injury or muscular injury or articular injury and with pharmacological, medical or physical therapy treatment in the moment that the intervention begins.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a pilot study, the number of participants needed for the investigation was determined by the number used in similar studies.

To evaluate the data first of all the data quality will be examinate, the outliers will be searched with Mahalanobis distance.
After that Shapiro-Wilks will be use to see the normality of the dependent variables.
The analysis will continue with the descriptive analysis of the cualitative ordinal variables, the median and quartiles first and third will be shown.
The initial homogeneity of the groups will be checked with the U of Mann-Whitney.
After that, an analysis will be done to see the differences between the different measures (Pre-test, Post-test and Post-test1). Each group will be considered isolated for the analysis. For it, it will be used the K test for related samples and the ANOVA of Friedman and the analysis will be completed with the test of comparison by pairs of measurements.
Finally the contrast of the efficacy of both groups will be done by comparing the values of the differences variables by the U of Mann-Whitney test. And this test will be completed by the calculation of the effect size.
Every test will be done with a confidence interval of 95% and a signification level of a=0'05.
The analysis will be done by intention of treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7829 0
Spain
State/province [1] 7829 0
Valencia

Funding & Sponsors
Funding source category [1] 293410 0
Self funded/Unfunded
Name [1] 293410 0
Elena Mendez
Address [1] 293410 0
Avda. Comunitat Valenciana 99, 46770, Xeraco (Valencia), SPAIN
University of Alcala de Henares
Country [1] 293410 0
Spain
Primary sponsor type
University
Name
University of Alcala de Henares
Address
Colegio de San Ildefonso, Plaza de San Diego s/n
28801 Alcala de Henares (Madrid)
Country
Spain
Secondary sponsor category [1] 292237 0
None
Name [1] 292237 0
Address [1] 292237 0
Country [1] 292237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294892 0
Comite de Etica de Investigacion y Experimentacion Animal (CEI) de la Universidad de Alcala
Ethics committee address [1] 294892 0
Plaza de San Diego, s/n
28801 Alcala de Henares
Madrid
Ethics committee country [1] 294892 0
Spain
Date submitted for ethics approval [1] 294892 0
10/12/2015
Approval date [1] 294892 0
05/02/2016
Ethics approval number [1] 294892 0
CEIH/HU/2015/32

Summary
Brief summary
The main purpose of the study is to compare a pain education program with a tendinopathy education program both combined with eccentric exercises to determine which decrease most the pain and increase the most the life quality in sports players with chronic patellar tendinopathy.
The study hypothesize that a combined program of education with eccentric exercises will provide better results than an eccentric exercise program alone, and as the chronic patellar tendinopathy is a dysfunctional pain and not exactly a chronic pain, it's been hypothesize that a tendinopathy education program will give better results than a pain education program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63514 0
Miss Elena Mendez Meri
Address 63514 0
Avenida Comunitat Valenciana, 99, 2 floor, door A
46770 Xeraco
Spain
University of Alcala de Henares
Country 63514 0
Spain
Phone 63514 0
+34666900645
Fax 63514 0
Email 63514 0
elenamendezmeri@gmail.com
Contact person for public queries
Name 63515 0
Miss Elena Mendez Meri
Address 63515 0
Avenida Comunitat Valenciana, 99, 2 floor, door A
46770 Xeraco
Spain
University of Alcala de Henares
Country 63515 0
Spain
Phone 63515 0
+34666900645
Fax 63515 0
Email 63515 0
elenamendezmeri@gmail.com
Contact person for scientific queries
Name 63516 0
Miss Elena Mendez Meri
Address 63516 0
Avenida Comunitat Valenciana, 99, 2 floor, door A
46770 Xeraco
Spain
University of Alcala de Henares
Country 63516 0
Spain
Phone 63516 0
+34666900645
Fax 63516 0
Email 63516 0
elenamendezmeri@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary