- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07823933
The Effect of TECAR Therapy on Pain and Shoulder Function in Patients With Rotator Cuff Tendinopathy
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayşe U Baykut
- Phone Number: +0905367355246
- Email: drukbe@hotmail.com
Study Contact Backup
- Name: kerem Çekinel
Study Locations
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Çankaya
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Ankara, Çankaya, Turkey (Türkiye)
- Bilkent City Hospital
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Contact:
- Ayşe U Baykut
- Phone Number: +0905367355246
- Email: drukbe@hotmail.com
-
Sub-Investigator:
- kerem çekinel
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Sub-Investigator:
- Güldal F Yüzer Nakipoğlu
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Sub-Investigator:
- Nilüfer K Ordu Gökkaya
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Sub-Investigator:
- Rabia Can
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
- Pregnancy
- Infection
- Pacemaker
- Peripheral circulatory disorder
- Known concomitant malignancy or end-stage organ failure
- Intra-articular/subacromial steroid injection within the last 6 weeks or NSAID treatment within the last week.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Physical Therapy Group
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.
|
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.
|
|
Active Comparator: TECAR Group
In addition to exercise, TECAR therapy will be administered for a total of 10 sessions-at a frequency of 448 kHz and a duration of 25 minutes per session (10 minutes in capacitive mode and 15 minutes in resistive mode)-with a frequency of 5 sessions per week.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
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.
|
Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder joint range of motion measurements
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.
|
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
Time Frame: Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
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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.
|
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 Disabilty Index
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.
|
Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
|
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Nottingham Health Profile (NHP)
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.
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Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ayşe U BAYKUT, Ankara City Hospital Bilkent
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACHBİLKENTAUBAYKUT006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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