Bilkent City Hospital
Ankara, Çankaya, Turkey (Türkiye)
Location contact
Ayşe U Baykut
CONTACT
Güldal F Yüzer Nakipoğlu
SUB_INVESTIGATOR
Nilüfer K Ordu Gökkaya
SUB_INVESTIGATOR
Rabia Can
SUB_INVESTIGATOR
kerem çekinel
SUB_INVESTIGATOR
NCT Number: NCT07823933
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Ankara, Çankaya, Turkey (Türkiye)
Ayşe U Baykut
CONTACT
Güldal F Yüzer Nakipoğlu
SUB_INVESTIGATOR
Nilüfer K Ordu Gökkaya
SUB_INVESTIGATOR
Rabia Can
SUB_INVESTIGATOR
kerem çekinel
SUB_INVESTIGATOR
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. Its prevalence is estimated to be between 15% and 30% of the population. The most common cause of shoulder pain is rotator cuff (RC) tendinopathy. This structure surrounds the shoulder and comprises the supraspinatus, infraspinatus, subscapularis, and teres minor muscles, as well as the long head of the biceps brachii-though some authors exclude the biceps brachii. Rotator cuff tendinopathy is a prevalent health issue characterized by chronic degeneration resulting from repetitive stress on the shoulder. This degeneration can lead to a range of clinical presentations, varying from simple tendinosis to partial- or full-thickness rotator cuff tears. Multiple factors-such as excessive tensile loading, primary and secondary subacromial impingement, and deficiencies in repair mechanisms-play a role in the development of rotator cuff tendinopathy. 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). It has beneficial effects, particularly in musculoskeletal conditions, by reducing pain and improving functional status. Its efficacy has been investigated-and improvements reported-in conditions such as lower back pain, knee pain, Achilles tendon pathologies, rotator cuff tendon pathologies, pelvic floor disorders, lymphedema, and visceral pathologies like chronic constipation.
There are few studies in the literature regarding the efficacy of TECAR therapy in patients with rotator cuff tendinopathy, and no studies comparing it with exercise have been found. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 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).
A 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.
Time frame: Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
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.
Time frame: Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
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.
Time frame: Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
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.
Time frame: Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
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.
Time frame: Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
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.
Contact information is provided by the study sponsor or research team.
Ayşe Ukbe Baykut
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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