About this trial
Shoulder pain is one of the most common symptoms of musculoskeletal injuries; one-quarter of the general population and two-thirds of adults experience this problem at some point in their lives.Rotator cuff tendinopathy also presents as a significant socio-economic issue, affecting patients' functionality, sleep, quality of life, and work performance.
TECAR therapy (Targeted Radiofrequency Therapy) is a relatively new physical therapy method. This technique aims to induce hyperthermia in deep tissues by transferring high-frequency electromagnetic energy via capacitive-resistive electric transfer (CRET). This study aims to directly compare TECAR-a relatively new treatment modality-with exercise, which is crucial in shoulder rehabilitation, by evaluating the effects of both treatments on pain reduction, shoulder function, and quality of life in patients with rotator cuff tendinopathy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals experiencing pain in the shoulder and/or lateral deltoid region, with pain exacerbation during overhead activities.
Individuals exhibiting tenderness upon palpation at the rotator cuff tendon insertion site on the proximal humerus and/or restricted range of motion during active shoulder flexion, abduction, and internal and external rotation upon physical examination.
Individuals diagnosed with rotator cuff tendinosis or a partial-thickness tendon tear via imaging methods (ultrasound, magnetic resonance imaging).
Disqualifiers
Full-thickness rotator cuff tear
Previous shoulder surgery
Presence of other conditions capable of causing shoulder pain and loss of function (other joint pathologies, cervical radiculopathy, etc.)
Systemic diseases such as diabetes, rheumatoid arthritis, hepatitis, or coagulopathy
Trial design
Crossover
Treatments tested in this trial
tecar therapy
DeviceA shoulder exercise program-comprising range-of-motion exercises, stretching exercises (including the posterior joint capsule and pectoral muscles), rotator cuff strengthening exercises, and scapular mobilization exercises-will be administered over a total of 10 sessions, at a frequency of 5 sessions per week. In addition to the exercises, TECAR therapy will be administered over a total of 10 sessions (5 sessions per week), consisting of a total duration of 25 minutes (10 minutes in capacitive mode and 15 minutes in resistive mode at a frequency of 448 kHz).
physical therapy
Other interventionA total of 10 treatment sessions-consisting of 5 sessions per week-will be administered, comprising a shoulder exercise program that includes range-of-motion exercises, stretching exercises (targeting the posterior joint capsule and pectoral muscles), rotator cuff strengthening exercises, and scapular mobilization exercises.
Treatment groups
Trial outcomes
Primary outcomes
Visual Analogue Scale (VAS)
Visual Analog Scale (VAS): Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Participants will mark the point on the scale that best represents their perceived pain intensity at the time of assessment. Higher scores indicate greater pain intensity.
Secondary outcomes
Shoulder joint range of motion measurements
Shoulder Joint Range of Motion (ROM): Joint range of motion will be assessed using a standard goniometer. The range of motion of the specified joint(s) will be measured in degrees (°) according to standardized measurement procedures. Higher values indicate a greater range of joint motion.
Western Ontario Rotator Cuff Index
Western Ontario Rotator Cuff Index (WORC): The Western Ontario Rotator Cuff Index (WORC) is a patient-reported outcome measure used to assess health-related quality of life in individuals with rotator cuff disorders. It consists of 21 items covering five domains: physical symptoms, sports/recreation, work, lifestyle, and emotions. Each item is scored on a visual analog scale. The total score is transformed to a 0-100 scale, with higher scores indicating poorer quality of life.
Shoulder Pain and Disabilty Index
Shoulder Pain and Disability Index (SPADI): The Shoulder Pain and Disability Index (SPADI) is a patient-reported outcome measure designed to assess pain and disability related to shoulder disorders. It consists of 13 items divided into two subscales: pain (5 items) and disability (8 items). Each item is scored on a visual analog scale from 0 to 10. The total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
Nottingham Health Profile (NHP)
Nottingham Health Profile (NHP): The Nottingham Health Profile (NHP) is a patient-reported outcome measure used to assess perceived health-related quality of life. It consists of 38 yes/no items covering six domains: energy level, pain, emotional reactions, sleep, social isolation, and physical mobility. Each domain is scored from 0 to 100, with higher scores indicating greater perceived health problems and poorer health-related quality of life.
Sponsors and contacts
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Ayşe Ukbe Baykut
Lead sponsor
Ankara City Hospital Bilkent
Sponsor institution
Ankara Bilkent Sehir Hastanesi
Collaborator
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