- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06729437
Transcranial Direct Current Stimulation on Functionality and Pain in Individuals With Patellar Tendinopathy
Effectiveness of Transcranial Direct Current Stimulation on Functionality and Pain in Individuals With Patellar Tendinopathy: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patellar tendinopathy is a painful condition affecting the anterior portion of the knee, commonly exacerbated by activities putting pressure on the patellofemoral joint. It remains a challenge for the healthcare system, not only due to its high prevalence, but also because of its high persistence and negative consequences. Although therapeutic exercise has been widely studied as a treatment strategy, eccentric exercise protocols, while effective, often require long application periods, which may affect treatment adherence. Additionally, eccentric exercise is pain-provoking and its therapeutic benefits for pain relief and functional improvement are controversial when used during the competitive season. More adaptable and personalized treatment strategies could enhance clinical outcomes and treatment adherence in patients with patellar tendinopathy. In this context, interventions combining exercise with other techniques have been proposed. However, existing evidence does not definitively determine the optimal approach for combining conservative treatment options to maximize benefits.
An emerging therapeutic approach combines Transcranial Direct Current Stimulation (tDCS) with therapeutic exercise protocols. tDCS involves the application of weak direct current to specific cortical areas, aiming to modulate brain excitability. This non-invasive method offers painless, selective, and focal stimulation with minimal side effects. Research increasingly supports the effectiveness of integrating tDCS with exercise for patellar tendinopathy, offering the potential to amplify exercise effects by modulating brain excitability. However, to date, no study has investigated the impact of tDCS combined with eccentric exercise on variables related to function and pain in patellar tendinopathy individuals.
Therefore, the aim of this study is to investigate the effectiveness of tDCS prior to a therapeutic eccentric exercise program on parameters related to pain and functionality in individuals with patellar tendinopathy.
This study is a randomized clinical trial in which two groups will participate, with different interventions: i) Experimental group: tDCS + Therapeutic eccentric exercise; and ii) Control group: Sham tDCS + Therapeutic eccentric exercise. The interventions will last for 8 weeks. Participants will be evaluated in four moments, at baseline, week 4, week 8 and week 12. The variables studied are related to pain, functionality, muscle strength and activity, proprioception, and quality of life.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marta Inglés, Dr
- Phone Number: 963 98 38 55
- Email: marta.ingles@uv.es
Study Contact Backup
- Name: Elena Muñoz-Gómez, Dr
- Phone Number: 963 98 38 55
- Email: elena.munoz-gomez@uv.es
Study Locations
-
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Valencia
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Valencia, Valencia, Spain, 46022
- Recruiting
- Faculty of Physiotherapy, University of Valencia
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Contact:
- Marta Inglés, PhD
- Phone Number: (+34) 96 398 38 55
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 50 years.
- Diagnosis of patellar tendinopathy (VISA-P score of 80 or lower).
- Pain lasting more than 3 months.
Exclusion Criteria:
- Previous knee surgery.
- Corticosteroid injection in the previous 6 weeks.
- Systemic inflammatory, autoimmune, or rheumatic diseases.
- Cognitive or behavioural issues that hinder comprehension and adherence to the intervention.
- Any neurological disease.
- Neoplastic disease.
- Subjects presenting contraindications for tDCS (Thair et al., 2017), including: personal and family history of epilepsy, metallic implants in the head, implanted medication pump, pacemaker, recurrent headaches, skin conditions (psoriasis, eczema), or major head surgeries, pregnancy, heart diseases, and various medications (psychotropic or antihistamines).
- Subjects must not have undergone pharmacological treatment or knee physical rehabilitation programs for a period of 1 year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Participants will undergo an 8-week intervention of supervised eccentric exercise by a physiotherapist (3 sessions/week).
During the first 4 weeks, real tDCS will be administered at a rate of 3 sessions per week (12 in total) as an adjunct to exercise .
A direct current of 1.5 mA will be applied for 20 minutes to the primary motor cortex (M1) during each session of eccentric exercises.
Additionally, all participants will perform the eccentric exercise program on the remaining weekdays at home unsupervised.
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A direct current of 1.5 mA will be applied for 20 minutes to the primary motor cortex (M1) during each session of eccentric exercises.
|
|
Placebo Comparator: Sham group
Participants will undergo an 8-week intervention of supervised eccentric exercise by a physiotherapist (3 sessions/week).
During the first 4 weeks, sham tDCS will be administered at a rate of 3 sessions per week (12 in total) as an adjunct to exercise.
The current will be interrupted after 30 seconds.
Additionally, all participants will perform the eccentric exercise program on the remaining weekdays at home unsupervised.
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The current will be interrupted after 30 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee functionality
Time Frame: 5 minutes
|
The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies.
It consists of 8 items with a rating range from 0 to 100.
The optimal state would correspond to a score of 100.
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 2 minutes
|
The single-leg squat pain provocation test is used to monitor the response to previous loading in athletes with patella tendinopathy.
A visual analogue scale (VAS) will be used to determine pain intensity during the test.
A score of 0 points indicates no pain and 10 points is the worst imaginable pain.
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2 minutes
|
|
Health-related quality of life
Time Frame: 2 minutes
|
The EuroQol 5 dimensions (EQ-5D) test is an instrument which evaluates the generic quality of life.
Scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
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2 minutes
|
|
Muscle strength
Time Frame: 10 minutes
|
Maximum voluntary isometric contraction of the quadriceps, hamstrings, and hip abductors will be measured using a force sensor connected to the corresponding software (Chronojump Boscosystem).
Higher values indicate greater muscle strength.
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10 minutes
|
|
Electromyographic activity of lower limb muscles
Time Frame: 5 minutes
|
Electromyographic activity during maximum voluntary isometric contraction of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles, using electromyography, will be registered.
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5 minutes
|
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Muscle flexibility
Time Frame: 5 minutes
|
Knee joint range of motion will be measured in flexion and extension using a goniometer.
Higher values indicate greater muscle flexibility.
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5 minutes
|
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Muscle tone
Time Frame: 5 minutes
|
The biomechanical and viscoelastic properties of the muscle tissue will be evaluated using a non-invasive myometer, MyotonPRO (Myoton AS, Tallinn, Estonia).
The patellar tendon, rectus femoris, vastus medialis, vastus lateralis, semitendinosus, and biceps femoris will be assessed.
Higher values may indicate greater muscle stiffness or tone.
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5 minutes
|
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Proprioception
Time Frame: 5 minutes
|
Proprioception will be assessed using the active knee repositioning test with an inclinometer.
The difference between the target angle and the obtained angle will be registered.
A smaller difference between the angles indicates better knee proprioception.
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5 minutes
|
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Patient global perception of change
Time Frame: 1 minute
|
The Patient Global Impression of Change Scale (PGIC) will be filled out.
It consists of 7 points, with options ranging from "1=much better" to "7=much worse".
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1 minute
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marta Inglés, Dr, Univeristy of Valencia
Publications and helpful links
General Publications
- Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
- Thair H, Holloway AL, Newport R, Smith AD. Transcranial Direct Current Stimulation (tDCS): A Beginner's Guide for Design and Implementation. Front Neurosci. 2017 Nov 22;11:641. doi: 10.3389/fnins.2017.00641. eCollection 2017.
- Breda SJ, Oei EHG, Zwerver J, Visser E, Waarsing E, Krestin GP, de Vos RJ. Effectiveness of progressive tendon-loading exercise therapy in patients with patellar tendinopathy: a randomised clinical trial. Br J Sports Med. 2021 May;55(9):501-509. doi: 10.1136/bjsports-2020-103403. Epub 2020 Nov 20.
- Hernandez-Sanchez S, Hidalgo MD, Gomez A. Cross-cultural adaptation of VISA-P score for patellar tendinopathy in Spanish population. J Orthop Sports Phys Ther. 2011 Aug;41(8):581-91. doi: 10.2519/jospt.2011.3613. Epub 2011 Jul 12.
- Cosca DD, Navazio F. Common problems in endurance athletes. Am Fam Physician. 2007 Jul 15;76(2):237-44.
- Hedayatpour N, Falla D. Physiological and Neural Adaptations to Eccentric Exercise: Mechanisms and Considerations for Training. Biomed Res Int. 2015;2015:193741. doi: 10.1155/2015/193741. Epub 2015 Oct 12.
- Peers KH, Lysens RJ. Patellar tendinopathy in athletes: current diagnostic and therapeutic recommendations. Sports Med. 2005;35(1):71-87. doi: 10.2165/00007256-200535010-00006.
- Teixeira PEP, Alawdah L, Alhassan HAA, Guidetti M, Priori A, Papatheodorou S, Fregni F. The Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) combined with Physical Therapy on Common Musculoskeletal Conditions: A Systematic Review and Meta-Analysis. Princ Pract Clin Res. 2020 Jan-Apr;6(1):23-26. doi: 10.21801/ppcrj.2020.61.5. Epub 2020 May 21.
- Vander Doelen T, Jelley W. Non-surgical treatment of patellar tendinopathy: A systematic review of randomized controlled trials. J Sci Med Sport. 2020 Feb;23(2):118-124. doi: 10.1016/j.jsams.2019.09.008. Epub 2019 Sep 13.
- Visnes H, Hoksrud A, Cook J, Bahr R. No effect of eccentric training on jumper's knee in volleyball players during the competitive season: a randomized clinical trial. Clin J Sport Med. 2005 Jul;15(4):227-34. doi: 10.1097/01.jsm.0000168073.82121.20.
- Young MA, Cook JL, Purdam CR, Kiss ZS, Alfredson H. Eccentric decline squat protocol offers superior results at 12 months compared with traditional eccentric protocol for patellar tendinopathy in volleyball players. Br J Sports Med. 2005 Feb;39(2):102-5. doi: 10.1136/bjsm.2003.010587.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-FIS-3100133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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