Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000326493
Ethics application status
Approved
Date submitted
23/01/2025
Date registered
17/04/2025
Date last updated
15/06/2025
Date data sharing statement initially provided
17/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a Physical Rehabilitation Protocol on Pain and Performance in Athletes with Patellar Tendinopathy
Scientific title
Effects of a Physical Rehabilitation Protocol on Neuromuscular Function, Tendon Thickness, and Pain in Athletes with Patellar Tendinopathy: A Randomized Controlled Trial
Secondary ID [1] 313797 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellar Tendinopathy 336432 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332952 332952 0 0
Other physical medicine / rehabilitation
Musculoskeletal 332953 332953 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 8-week intervention includes eccentric training, static stretching, and extracorporeal shock wave therapy (ESWT), conducted five days per week. Initial sessions are supervised by physiotherapists at the University of Córdoba; subsequent sessions are home-based.

Eccentric Training:
Single-leg decline squats (25°) to 90° knee flexion, 3 sets of 10 reps, 6 times/week. Pain monitored via VAS; load increased by 5 kg if VAS less than 3. Adherence tracked with participant diaries reviewed weekly.

Static Stretching:
Quadriceps and hamstring stretches before and after training (30 seconds per muscle). Total: 2 minutes/session. Initially supervised, then self-administered. Recorded in the same exercise diary.

ESWT:
Five sessions over 8 weeks (1x/10 days initially, then twice in weeks 6 and 8) of 10 minutes duration. Delivered by a physiotherapist using Storz MP100 (2000 impulses, 4 Hz, 0.15 mJ/mm²). Attendance recorded by the therapist.
Intervention code [1] 330385 0
Treatment: Other
Comparator / control treatment
The control group will follow a placebo rehabilitation program, including weekly physiotherapy sessions involving static stretching and flexibility exercises for the hip and ankle flexor muscles. No extracorporeal shock wave therapy were included in control condition group.
Control group
Active

Outcomes
Primary outcome [1] 340487 0
Pain Perception
Timepoint [1] 340487 0
Pain Perception (VISA-P) Baseline Week 0 (Pre-Intervention): Participants complete the VISA-P questionnaire to establish initial pain levels and functional limitations. Mid-Intervention (Week 4): VISA-P scores are recorded to monitor changes in pain perception during the rehabilitation program. Post-Intervention (Week 8): Final VISA-P scores are collected to assess the immediate impact of the intervention. Follow-Up (1 Year): VISA-P scores are re-assessed to evaluate the long-term effectiveness of the program in reducing pain and restoring function.
Primary outcome [2] 340490 0
Tendon Thickness
Timepoint [2] 340490 0
Baseline Week 0 (Pre-Intervention): Tendon thickness is measured to determine the initial structural state of the patellar tendon. Mid-Intervention (Week 4): Measurements are taken to observe any short-term structural changes in the tendon. Post-Intervention (Week 8): Tendon thickness is re-evaluated to analyze the final impact of the rehabilitation program on tendon morphology. Follow-Up (1 Year): Additional measurements are conducted to monitor long-term structural adaptations in the tendon.
Primary outcome [3] 340491 0
Neuromuscular performance
Timepoint [3] 340491 0
Baseline Week 0 (Pre-Intervention), Mid-Intervention (Week 4), Post-Intervention (Week 8) and Follow-Up (1 Year): A final test is administered to analyze the long-term retention of strength gains.
Secondary outcome [1] 444250 0
Body Composition (BIA)
Timepoint [1] 444250 0
Baseline (Pre-Intervention): Body composition is measured to establish baseline values for fat mass, lean mass, and overall composition. Mid-Intervention (Week 4): BIA is conducted to observe short-term changes in body composition during the program. Post-Intervention (Week 8): Final measurements are taken to analyze the impact of the rehabilitation program on body composition. Follow-Up (1 Year): Body composition is re-measured to assess long-term adaptations.

Eligibility
Key inclusion criteria
i) age between 18 and 49 years; ii) hold a valid federation licence in a sport that involves repeated impacts on the knee (basketball, volleyball, handball, athletics, etc.); iii) not have trained at least three times a week; iv) not have undergone knee surgery in the year prior to the start of the study; v) not have supplemented with any nutritional supplementation per week. ); iii) train at a minimum frequency of three sessions per week; iv) not have undergone knee surgery in the year prior to the start of the research; v) not have supplemented with any nutritional supplement during the three months prior to the start of the research; vi) not have undergone any analgesic or platelet-rich plasma infiltration during the previous year; vii) not be a smoker.
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Someone that not have patellar tendinopathy

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Assignment was randomly created by software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be presented as mean (M) ± standard deviation (SD). The Shapiro-Wilk test will be used to check that the different variables conform to the behaviour of the normal distribution, and the Levene test will be used to check homoscedasticity. Subsequently, to analyse possible variations in the variables analysed throughout the intervention (PRE - INT - POST), an analysis of variance for repeated measures (ANOVA-MR) will be applied. In addition, effect size (ES) will be calculated using partial eta squared (?2p), considering ES values of low (<0.25), moderate (>0.26<0.63) and high (>0.63) (Ferguson, 2009). In addition, for all variables where statistically significant differences are obtained in the ANOVA-MR, a Bonferroni Post-Hoc will be applied. A statistical significance level of p<0.05 will be set. All statistical treatments will be performed using the Statistical Package for Social Sciences (version 23.0, SPSS™ Inc., Chicago, IL, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2025
Actual
21/04/2025
Date of last participant enrolment
Anticipated
30/04/2025
Actual
30/04/2025
Date of last data collection
Anticipated
Actual
9/06/2025
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 26841 0
Spain
State/province [1] 26841 0

Funding & Sponsors
Funding source category [1] 318264 0
Self funded/Unfunded
Name [1] 318264 0
Angel Carnero - Universidad de Sevilla
Country [1] 318264 0
Spain
Primary sponsor type
Individual
Name
Angel Carnero - Universidad de Sevilla
Address
Country
Spain
Secondary sponsor category [1] 320649 0
None
Name [1] 320649 0
Address [1] 320649 0
Country [1] 320649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316904 0
CEIm Hospital Clínico San Carlos
Ethics committee address [1] 316904 0
Ethics committee country [1] 316904 0
Spain
Date submitted for ethics approval [1] 316904 0
20/01/2025
Approval date [1] 316904 0
26/05/2025
Ethics approval number [1] 316904 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139382 0
Mr Angel Carnero Diaz
Address 139382 0
Universidad de Sevilla, C. Pirotecnia, s/n, 41013 Sevilla
Country 139382 0
Spain
Phone 139382 0
+34666633451
Fax 139382 0
Email 139382 0
[email protected]
Contact person for public queries
Name 139383 0
Angel Carnero Diaz
Address 139383 0
Universidad de Sevilla, C. Pirotecnia, s/n, 41013 Sevilla
Country 139383 0
Spain
Phone 139383 0
+34666633451
Fax 139383 0
Email 139383 0
[email protected]
Contact person for scientific queries
Name 139384 0
Angel Carnero Diaz
Address 139384 0
Universidad de Sevilla, C. Pirotecnia, s/n, 41013 Sevilla
Country 139384 0
Spain
Phone 139384 0
+34666633451
Fax 139384 0
Email 139384 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• anyone who wishes to access it

Conditions for requesting access:
• -

What individual participant data might be shared?
• Only data collected during the trial related to outcomes primary and secundary

What types of analyses could be done with individual participant data?
• any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication and with no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Universidad de Sevilla repository when DOI will be available or in [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.