Transcranial Direct Current Stimulation on Functionality and Pain in Individuals With Patellar Tendinopathy

Official title

Effectiveness of Transcranial Direct Current Stimulation on Functionality and Pain in Individuals With Patellar Tendinopathy: Randomized Clinical Trial

Overview

The aim of the present study is to investigate the effectiveness of transcranial direct current stimulation (tDCS) prior to a therapeutic eccentric exercise program on parameters related to pain and functionality in individuals with patellar tendinopathy. For this purpose, participants will be randomly divided into two groups: i) experimental group, receiving tDCS prior to a therapeutic exercise program; and ii) control group, receiving sham tDCS and a therapeutic exercise program. The interventions will last for 8 weeks. Additionally, four assessments will be conducted (baseline, week 4, week 8 and week 12). The variables studied are related to pain, functionality, muscle activity and strength, proprioception, and quality of life.

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.

Interventions

• Other 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.
• Other Sham tDCS + Therapeutic eccentric exercise
  The current will be interrupted after 30 seconds.

Primary outcome measures

• Knee functionality [Time frame: 5 minutes]

Secondary outcome measures (8)

• Pain intensity [Time frame: 2 minutes]
• Health-related quality of life [Time frame: 2 minutes]
• Muscle strength [Time frame: 10 minutes]
• Electromyographic activity of lower limb muscles [Time frame: 5 minutes]
• Muscle flexibility [Time frame: 5 minutes]
• Muscle tone [Time frame: 5 minutes]
• Proprioception [Time frame: 5 minutes]
• Patient global perception of change [Time frame: 1 minute]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Faculty of Physiotherapy, University of Valencia — Valencia

Publications

• 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. PMID 33219115
• Cosca DD, Navazio F. Common problems in endurance athletes. Am Fam Physician. 2007 Jul 15;76(2):237-44. PMID 17695568
• 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. PMID 26543850
• 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. PMID 21765223
• 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 2 PMID 27372845
• 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. PMID 15651914
• 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. PMID 32766451
• 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. PMID 29213226

Identifiers

NCT: NCT06729437 · 2023-FIS-3100133

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗