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

NCT06729437 | Recruiting

• 1 other identifier: 2023-FIS-3100133
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Tendinopathy

Keywords

patellar tendinopathy; transcranial direct current stimulation; therapeutic exercise; eccentric exercise

Outcome Measures

Primary Outcomes (1)

• Knee functionality

  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 Outcomes (8)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: tDCS + Therapeutic eccentric exercise

Sham group

PLACEBO COMPARATOR

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.

Other: Sham tDCS + Therapeutic eccentric exercise

Interventions

tDCS + Therapeutic eccentric exercise OTHER

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.

Experimental group

Sham tDCS + Therapeutic eccentric exercise OTHER

The current will be interrupted after 30 seconds.

Sham group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 50 years.
• Diagnosis of patellar tendinopathy (VISA-P score of 80 or lower).
• Pain lasting more than 3 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy, University of Valencia

Valencia, Valencia, 46022, Spain

RECRUITING

Related Publications (11)

• 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.

  PMID: 8070614 BACKGROUND

• Cosca DD, Navazio F. Common problems in endurance athletes. Am Fam Physician. 2007 Jul 15;76(2):237-44.

  PMID: 17695568 BACKGROUND

• Vairel EG. [Enzyme systems and the means to study them]. Biol Med (1971). 1973 Dec;2(2):123-39. No abstract available. French.

  PMID: 4620252 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 27372845 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 7406123 BACKGROUND

• 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.

  PMID: 5702643 BACKGROUND

• 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.

  PMID: 31606317 BACKGROUND

• 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.

  PMID: 16003036 BACKGROUND

• Srivastava RA, Schonfeld G. Use of riboprobes for northern blotting analysis. Biotechniques. 1991 Nov;11(5):584, 586, 588.

  PMID: 1725109 BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Marta Inglés, Dr

  Univeristy of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Inglés, Dr

CONTACT

963 98 38 55; marta.ingles@uv.es

Elena Muñoz-Gómez, Dr

CONTACT

963 98 38 55; elena.munoz-gomez@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 11, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)