TECAR With Shoulder Chronic Shoulder Impingement Syndrome (TECAR /SIS)
Effect of Adjunctive TECAR Therapy on Clinical Outcomes in Patients With Chronic Shoulder Impingement Syndrome: a Randomized Controlled Trial
The study aimed to investigate the adjunctive effects of TECAR therapy in combination with conventional exercises compared with placebo TECAR combined with the same exercise program on pain intensity, shoulder function, range of motion, and muscle strength in individuals with subacromial syndrome.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Shoulder pain is the third most common musculoskeletal complaint in orthopedic practice. Shoulder pain affects approximately one-third of people in their lifetime. The prevalence of shoulder pain over one month has ranged between 16% and 30% of the population. One of the most common shoulder problems is shoulder impingement syndrome (SIS). Pain arises from shoulder impingement caused by rotator cuff compression and the subacromial bursa. Subacromial Impingement Syndrome is associated with changes in scapular kinematics, muscle activity, and capsular tightness. Restricted range of motion (ROM) and scapular pain are the primary manifestations of subacromial impingement syndrome (SIS); symptoms most commonly occur during limb abduction between 70-120 degrees and during overhead activities. The main therapeutic goals for individuals with SIS are to reduce pain and improve upper limb functional capacity. A cross-sectional study conducted in Egypt reported that the most common type of shoulder pain is shoulder impingement (SIS), accounting for 38.6% of shoulder pathologies TECAR therapy is a specialized form of energy based on a frequency range of 300 KHZ TO 1 MHZ. It uses high-frequency energy to stimulate cellular biological processes and self-regeneration. This therapy enhances natural physiological function and improves metabolism. TECAR therapy works by increasing temperature within deep dermal layers, which can affect the adipocyte membrane and release free fatty acids. This cellular response triggers the activation of macrophages and other inflammatory mediators, contributing to tissue remodeling. Clinically, Tecer therapy is used to manage soft tissue injuries by reducing edema, accelerating remodeling, and supporting the natural inflammatory process. It also aids in decreasing muscle hypertonicity, enhances tissue regeneration across joints and muscles, and relieves muscle and joint pain. Contributing to improving the range of motion and promoting local blood circulation.
Therefore, the present study aims to compare the effect of TECAR versus placebo, both combined with therapeutic exercise, on pain intensity, function, ROM, and muscle strength in patients with Shoulder impingement syndrome (SIS).
Evidence remains limited specifically regarding the use of TECAR therapy for Subacromial Impingement Syndrome (SIS), as previous studies have compared this treatment only with other adjunctive therapies, lacking a distinct control group receiving conventional treatment. The present study addresses this gap.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Amgad Tamer Farhat Elkhyat
- Telefonnummer: 01090005697
- E-post: amgad.23110702@muc.edu.eg
Studer Kontakt Backup
- Navn: Afaf Mohamed Omar Tahoon, Lecturer
- Telefonnummer: 01015401783
- E-post: afaf_tahoon@cu.edu.eg
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 1. Referred by an orthopedic physician with a clinical diagnosis (confirmed by imaging examination-magnetic resonance imaging or ultrasound) of Tendinopathy of any muscle of the Rotator cuff and pain in the shoulders for at least 3 months 2. Participants ranged in age from 30 to 55 years old 3. Numerical pain rating scale (NPRS)≥4: 4. Four of the following should be present in the included patients: Neer impingement test, Hawkins' test, Pain was replicated in the supraspinatus empty-can test, a painful arc of movement from 70° to 120°, and pain at the greater tuberosity of the humerus 5. BMI range 18.5- 29. 9 Kg/m².
Exclusion Criteria:
-
(1) Patients who have a full-thickness rotator cuff tear. (2) History of shoulder or rotator cuff surgery or fracture, glenohumeral joint dislocation, rheumatoid arthritis (affected side).
(3) Pharmacological medical treatment that may interfere with the measurements; history of corticosteroid injections in the last three months.
(4) Patients who received rehabilitation therapy in the last 3 months. (5) Patients who have symptoms of numbness or tingling in the upper extremity. (6) A history of the following: onset of symptoms due to traumatic injury. (7) Patients who have cognitive or psychiatric disorders or pregnancy. (8) Patients who have a positive Drop arm sign. (9) Patients who have cervical radiculopathy.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: TECAR therapy with conventional exercise
Patients will receive TECAR therapy and conventional exercise for 6 weeks (3 sessions per week), consisting of 2 sessions per week of TECAR therapy and conventional exercises, and one session of conventional exercises only at-home exercises |
TECAR therapy: Received for 8 sessions during the intervention period. Each session consisted of 20 minutes: 10 minutes in capacitive mode at 100 W, followed by 10 minutes in resistive mode at 200 W. The device was operated at a pulsed frequency, The program included three stretching exercises to address soft tissue restriction. It specifically targeted the upper trapezius, pectoralis minor, and posterior shoulder capsule. Each stretch was held for 30 seconds and repeated three times, with 30 seconds between repetitions Following the stretching exercises, participants completed a progressive strengthening program targeting the rotator cuff muscles and scapular stabilization. Participants performed strengthening exercises using color-coded elastic resistance bands, with 3 sets of 10 repetitions and 1 minute of rest between sets. Rotator cuff strengthening consisted of shoulder flexion, Abduction, External rotation, and Internal Rotation exercises. Scapular stabilization exercises included serratus anterior, middle trapezius, and lower trapezius muscle strengthening) |
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Sham-komparator: Passive TECAR therapy
Patients will receive Sham TECAR therapy and conventional exercise for 6 weeks (3 sessions per week), consisting of 2 sessions per week of Sham TECAR therapy and conventional exercises, and one session of conventional exercises only at-home exercises Both groups completed an identical exercise program consisting of stretching, strengthening, and Scapular stabilization |
sham treatment by TECAR device for 20 min without producing any waves. The program included three stretching exercises to address soft tissue restriction. It specifically targeted the upper trapezius, pectoralis minor, and posterior shoulder capsule. Each stretch was held for 30 seconds and repeated three times, with 30 seconds between repetitions Following the stretching exercises, participants completed a progressive strengthening program targeting the rotator cuff muscles and scapular stabilization. Participants performed strengthening exercises using color-coded elastic resistance bands, with 3 sets of 10 repetitions and 1 minute of rest between sets. Rotator cuff strengthening consisted of shoulder flexion, Abduction, External rotation, and Internal Rotation exercises. Scapular stabilization exercises included serratus anterior, middle trapezius, and lower trapezius muscle strengthening) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Numerical pain Rating scale:
Tidsramme: 6 weeks
|
The NPRS was used to assess the patient's shoulder pain intensity. Patients rated their current pain level on an 11-point scale from 0 (no pain) to 10 (worst pain imaginable). Ask participants to mark the point on the pain intensity scale |
6 weeks
|
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Shoulder function using the Shoulder Pain and Disability Index Questionnaire (SPADI):
Tidsramme: 6 weeks
|
The SPADI test consists of 13 items divided into two domains: the pain domain (5 items) and the disability domain (8 items). Each item is assigned a value from 0 to 10 on the NRS; the score ranges from 0 (no difficulty) to 10 (unable to perform). All the responses' ratings will be added and divided by the number of questions in that subscale. The total SPADI score will be calculated as the average of the 2 subscales |
6 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Shoulder Range of motion (ROM) by the Clinometer Smartphone Application
Tidsramme: 6 weeks
|
Clinometer application was used to measure shoulder ROM. The patient stands during shoulder flexion and abduction and is supine on the plinth when measuring internal and external rotation; the shoulder is abducted to 90°, the elbow bent to 90 °, and the forearm is in a neutral position. |
6 weeks
|
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Muscle strength: by (Hand-Held Dynamometry)
Tidsramme: 6 weeks
|
Isometric shoulder joint muscle strengths (flexion, abduction, external rotation) were measured with an HHD. The patient performs a maximal isometric muscle contraction for 3 seconds while the hand-held dynamometer is attached. The measurement is repeated three times, with a 30-second rest period between each measurement. |
6 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Salma Osama Abdelhameed Eid, Demonstrator, salma.Eid@bue.edu.eg
- Studiestol: Maram Ibrahim Ali Ibrahim, Demonstrator, Maram.Ibrahim@bue.edu.eg
- Studiestol: Tasbih Emad saber, tasbihemad87@gmail.com
- Studiestol: Sama Sayed Mohamed Sayed, samaasayed268@gamil.com
- Studiestol: Alaa Elsayed Atia Hassan, 10712023100273@stud.cu.edu.eg
- Studiestol: Esraa Mohamed Mosaid, esramohamedmosaid@gmail.com
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
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- TECAR With SIS
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