The Effect of TECAR Therapy on Pain and Shoulder Function in Patients With Rotator Cuff Tendinopathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAyşe Ukbe Baykut

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • tecar therapy

    Device

    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).

  • physical therapy

    Other intervention

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Physical Therapy GroupActive comparator 2 interventions
Group B: TECAR GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program

Secondary outcomes

1

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.

Time frame
Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
2

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.

Time frame
Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
3

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.

Time frame
Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program
4

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.

Time frame
Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program

Other outcomes

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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