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Clinical Trials/NCT06729437
NCT06729437
Recruiting
Not Applicable

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

University of Valencia1 site in 1 country42 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellar Tendinopathy
Sponsor
University of Valencia
Enrollment
42
Locations
1
Primary Endpoint
Knee functionality
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
July 1, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marta Inglés de la Torre

Assistant Professor of Physiotherapy

University of Valencia

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Study Sites (1)

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