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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Amgad Tamer Farhat Elkhyat
- Telefonszám: 01090005697
- E-mail: amgad.23110702@muc.edu.eg
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Afaf Mohamed Omar Tahoon, Lecturer
- Telefonszám: 01015401783
- E-mail: afaf_tahoon@cu.edu.eg
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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) |
|
Sham Comparator: 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) |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Numerical pain Rating scale:
Időkeret: 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
|
|
Shoulder function using the Shoulder Pain and Disability Index Questionnaire (SPADI):
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Shoulder Range of motion (ROM) by the Clinometer Smartphone Application
Időkeret: 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
|
|
Muscle strength: by (Hand-Held Dynamometry)
Időkeret: 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
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Tanulmányi szék: Salma Osama Abdelhameed Eid, Demonstrator, salma.Eid@bue.edu.eg
- Tanulmányi szék: Maram Ibrahim Ali Ibrahim, Demonstrator, Maram.Ibrahim@bue.edu.eg
- Tanulmányi szék: Tasbih Emad saber, tasbihemad87@gmail.com
- Tanulmányi szék: Sama Sayed Mohamed Sayed, samaasayed268@gamil.com
- Tanulmányi szék: Alaa Elsayed Atia Hassan, 10712023100273@stud.cu.edu.eg
- Tanulmányi szék: Esraa Mohamed Mosaid, esramohamedmosaid@gmail.com
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- TECAR With SIS
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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