Study Background and Purpose Tendinopathies are common and debilitating musculoskeletal disorders that often lead to chronic pain and reduced mobility. Traditional treatments face challenges due to limited tendon blood supply, leading to poor healing. This study investigates ultrasound-guided galvanic electrolysis therapy (USGET), which uses electric current to promote tendon healing, comparing its efficacy with a placebo. Objectives The primary goal is to assess pain reduction, while secondary goals evaluate functionality, elasticity, and morphological changes (imaging) in patients with patellar tendinopathy. Methodology * Design: Prospective, randomized, double-blind, placebo-controlled study. * Duration: 24 months (October 2024 - October 2026). * Groups: * Intervention Group: Electrolysis therapy with galvanic current, Progressive tendon-loading exercises. * Control Group: Electrolysis placebo (without current), Progressive tendon-loading exercises. * Sample Size: 74 subjects. * Data Collection: Baseline, post-treatment (4 months), and follow-up (7 months). Evaluation and Data Analysis The study assesses pain via VAS and functionality scores, alongside imaging (MRI, sonography) to measure tendon morphology. Statistical analysis includes hypothesis testing and regression using SPSS software. Ethics and Publication Ethics approval is from the Bremen Medical Chamber. Results will be published regardless of outcome, following Good Clinical Practice and the Declaration of Helsinki.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
Ultrasound-guided galvanic electrolysis (USGET) is a technique most commonly used on chronically affected tissue. A galvanic current flows through an acupuncture needle producing an inflammatory reaction in the tissue. The inflammatory reaction will trigger a host of biological processes in the body. These will ultimately start the generation of new immature collagen fibres. The fibres become mature by means of training stimulus. The technique shows good results on tendons in the chronic phase, and may be used for injuries, such as long-standing muscle injury and treatment of myofascial pain syndrome and trigger points.
The same intervention as the electrolysis group with the device turned on but the current intensity turned to 0 mA (e.g., no galvanic current).
Paracelsus Sportmedizin & Prävention Bremen
Bremen, City state Bremen, Germany
Visual Analogue Scale (VAS)
The pain Visual Analogue Scale (VAS) is a subjective, unidimensional measure of pain intensity, used to record patients' pain progression. It is a horizontal line, 100 mm in length, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks on the line the point that the patient believes represents his or her perception of his or her current state.
Time frame: Change from baseline to the end of treatment at 10 weeks
Visual Analogue Scale (VAS)
The pain Visual Analogue Scale (VAS) is a subjective, unidimensional measure of pain intensity, used to record patients' pain progression. It is a horizontal line, 100 mm in length, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks on the line the point that the patient believes represents his or her perception of his or her current state.
Time frame: Change from baseline to 7 months follow-up
Tegner Activity Scale
The Tegner Activity Scale (TAS) is a one-item score used to measure activity level, particularly in the context of knee injuries and sports. It uses a scale of 0 to 10, where 0 represents maximum disability and 10 represents participation in competitive sports at a national or international elite level.
Time frame: Change from baseline to the end of treatment at 10 weeks
Tegner Activity Scale
The Tegner Activity Scale (TAS) is a one-item score used to measure activity level, particularly in the context of knee injuries and sports. It uses a scale of 0 to 10, where 0 represents maximum disability and 10 represents participation in competitive sports at a national or international elite level.
Time frame: Change from baseline to 7 months follow-up
Visa-P
The Visa-P questionnaire (Victorian Institute of Sport Assessment - Patella) is a self-reported outcome measure that evaluates symptoms, function and the ability to play sports. The questionnaire consists of 8 questions designed to assess the patient's pain and functional ability during patellofemoral loading activities. The total score ranges from 0 to 100, with 100 representing an asymptomatic individual able to fully engage in sports and 0 representing the worst possible outcome.
Time frame: Change from baseline to the end of treatment at 10 weeks
Visa-P
The Visa-P questionnaire (Victorian Institute of Sport Assessment - Patella) is a self-reported outcome measure that evaluates symptoms, function and the ability to play sports. The questionnaire consists of 8 questions designed to assess the patient's pain and functional ability during patellofemoral loading activities. The total score ranges from 0 to 100, with 100 representing an asymptomatic individual able to fully engage in sports and 0 representing the worst possible outcome.
Time frame: Change from baseline to 7 months follow-up
International Knee Documentation Committee score
The International Knee Documentation Committee score (IKDC) is a tool used to assess knee function and symptoms. It's a patient-completed questionnaire that helps quantify how a person's knee is affecting their daily activities and sports participation. The score ranges from 0 to 100, with higher scores indicating better function and fewer symptoms.
Time frame: Change from baseline to the end of treatment at 10 weeks
International Knee Documentation Committee score
The International Knee Documentation Committee score (IKDC) is a tool used to assess knee function and symptoms. It's a patient-completed questionnaire that helps quantify how a person's knee is affecting their daily activities and sports participation. The score ranges from 0 to 100, with higher scores indicating better function and fewer symptoms.
Time frame: Change from baseline to 7 months follow-up
Comprehensive Aachen Knee Score
The Comprehensive Aachen Knee Score (COMPACK) is a novel, reliable and valid instrument to measure knee pain regarding two dimensions, intensity and frequency from the patient perspective. The total score consist of two subscales and ranges from 0 (no pain or frequency of pain) to 60 (the worst possible pain and pain frequency).
Time frame: Change from baseline to the end of treatment at 10 weeks
Comprehensive Aachen Knee Score
The Comprehensive Aachen Knee Score (COMPACK) is a novel, reliable and valid instrument to measure knee pain regarding two dimensions, intensity and frequency from the patient perspective. The total score consist of two subscales and ranges from 0 (no pain or frequency of pain) to 60 (the worst possible pain and pain frequency).
Time frame: Change from baseline to 7 months follow-up
B-scan sonography
B-scan sonography, or ultrasound imaging, is a valuable tool for assessing tendon conditions. It allows visualization of tendon structure, dimensions, and potential pathologies like tears or inflammation. B-mode ultrasound can show the fibrillar pattern of normal tendons and help identify abnormalities, such as the presence of tears or the degree of tendon retraction in cases of rupture
Time frame: Change from baseline to the end of treatment at 10 weeks
B-scan sonography
B-scan sonography, or ultrasound imaging, is a valuable tool for assessing tendon conditions. It allows visualization of tendon structure, dimensions, and potential pathologies like tears or inflammation. B-mode ultrasound can show the fibrillar pattern of normal tendons and help identify abnormalities, such as the presence of tears or the degree of tendon retraction in cases of rupture
Time frame: Change from baseline to 7 months follow-up
Doppler sonography
Doppler sonography, a type of ultrasound, is used to assess blood flow within tendons, particularly in conditions like tendinopathy or tendinosis. It can help visualize neovascularization (new blood vessel formation) within abnormal tendons.
Time frame: Change from baseline to the end of treatment at 10 weeks
Doppler sonography
Doppler sonography, a type of ultrasound, is used to assess blood flow within tendons, particularly in conditions like tendinopathy or tendinosis. It can help visualize neovascularization (new blood vessel formation) within abnormal tendons.
Time frame: Change from baseline to 7 months follow-up
Shear wave elastography
Shear wave elastography (SWE) is a non-invasive ultrasound technique that can be used to assess tendon stiffness and elasticity. It measures the speed of shear waves as they travel through the tendon, which can be related to the tissue's mechanical properties. SWE can help differentiate between healthy and pathological tendons, potentially aiding in the diagnosis and monitoring of tendinopathies
Time frame: Change from baseline to the end of treatment at 10 weeks
Shear wave elastography
Shear wave elastography (SWE) is a non-invasive ultrasound technique that can be used to assess tendon stiffness and elasticity. It measures the speed of shear waves as they travel through the tendon, which can be related to the tissue's mechanical properties. SWE can help differentiate between healthy and pathological tendons, potentially aiding in the diagnosis and monitoring of tendinopathies
Time frame: Change from baseline to 7 months follow-up
Magnetic resonance imaging
Magnetic resonance imaging (MRI) can be used to assess tendinopathy, by detecting structural changes and inflammatory processes. It's particularly useful for evaluating partial tears and postoperative assessment, offering better visualization than ultrasound in these situations. MRI can also identify other associated injuries like cartilage damage, bone abnormalities, and ligament injuries
Time frame: Change from baseline to the end of treatment at 10 weeks
Magnetic resonance imaging
Magnetic resonance imaging (MRI) can be used to assess tendinopathy, by detecting structural changes and inflammatory processes. It's particularly useful for evaluating partial tears and postoperative assessment, offering better visualization than ultrasound in these situations. MRI can also identify other associated injuries like cartilage damage, bone abnormalities, and ligament injuries
Time frame: Change from baseline to 7 months follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.