Transcranial Direct Current Stimulation on Functionality and Pain in Individuals with Patellar Tendinopathy
NCT ID: NCT06729437
Last Updated: 2025-02-28
Study Results
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Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2024-07-01
2027-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
tDCS + Therapeutic eccentric 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.
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.
Sham tDCS + Therapeutic eccentric exercise
The current will be interrupted after 30 seconds.
Interventions
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tDCS + Therapeutic eccentric 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.
Sham tDCS + Therapeutic eccentric exercise
The current will be interrupted after 30 seconds.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of patellar tendinopathy (VISA-P score of 80 or lower).
* Pain lasting more than 3 months.
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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University of Valencia
OTHER
Responsible Party
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Marta Inglés de la Torre
Assistant Professor of Physiotherapy
Principal Investigators
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Marta Inglés, Dr
Role: PRINCIPAL_INVESTIGATOR
Univeristy of Valencia
Locations
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Faculty of Physiotherapy, University of Valencia
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Marta Inglés, PhD
Role: primary
References
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Liang Y, Jetton TL, Zimmerman EC, Najafi H, Berner DK, Matschinsky FM, Magnuson MA. Effects of glucose on insulin secretion, glucokinase activity, and transgene expression in transgenic mouse islets containing an upstream glucokinase promoter-human growth hormone fusion gene. Diabetes. 1994 Sep;43(9):1138-45. doi: 10.2337/diab.43.9.1138.
Cosca DD, Navazio F. Common problems in endurance athletes. Am Fam Physician. 2007 Jul 15;76(2):237-44.
Vairel EG. [Enzyme systems and the means to study them]. Biol Med (1971). 1973 Dec;2(2):123-39. No abstract available. French.
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.
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.
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.
McKittrick JE, Henrikson J, Iwasiuk GW. Indications for contralateral carotid endarterectomy: role of the noninvasive laboratory. Am J Surg. 1980 Aug;140(2):206-8. doi: 10.1016/0002-9610(80)90006-9.
Dugois P, Amblard P, Gagnaire J, Imbert R. [Leg abscesses in stages after phlebosclerosus: complication of a septicemia of dental origin]. Bull Soc Fr Dermatol Syphiligr. 1968;75(4):518-20. No abstract available. French.
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.
Srivastava RA, Schonfeld G. Use of riboprobes for northern blotting analysis. Biotechniques. 1991 Nov;11(5):584, 586, 588.
Other Identifiers
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2023-FIS-3100133
Identifier Type: -
Identifier Source: org_study_id
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