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

Not Applicable

Recruiting

• Conditions: Patellar Tendinopathy

• Registration Number: NCT06729437
• Lead Sponsor: University of Valencia

Brief Summary

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.

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-07
• Study First Posted: 2024-12-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knee functionality	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.

Secondary Outcome Measures

Name	Time	Method
Pain intensity	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.
Health-related quality of life	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).
Muscle strength	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.
Electromyographic activity of lower limb muscles	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.
Muscle flexibility	5 minutes	Knee joint range of motion will be measured in flexion and extension using a goniometer. Higher values indicate greater muscle flexibility.
Muscle tone	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.
Proprioception	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.
Patient global perception of change	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".

Trial Locations

Locations (1)

Faculty of Physiotherapy, University of Valencia; 🇪🇸 Valencia, Spain