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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:Amgad Tamer Farhat Elkhyat
- 電話番号:01090005697
- メール:amgad.23110702@muc.edu.eg
研究連絡先のバックアップ
- 名前:Afaf Mohamed Omar Tahoon, Lecturer
- 電話番号:01015401783
- メール:afaf_tahoon@cu.edu.eg
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的: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) |
|
偽コンパレータ: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) |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numerical pain Rating scale:
時間枠: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):
時間枠: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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Shoulder Range of motion (ROM) by the Clinometer Smartphone Application
時間枠: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)
時間枠: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
|
協力者と研究者
捜査官
捜査官
- スタディチェア:Salma Osama Abdelhameed Eid, Demonstrator、salma.Eid@bue.edu.eg
- スタディチェア:Maram Ibrahim Ali Ibrahim, Demonstrator、Maram.Ibrahim@bue.edu.eg
- スタディチェア:Tasbih Emad saber、tasbihemad87@gmail.com
- スタディチェア:Sama Sayed Mohamed Sayed、samaasayed268@gamil.com
- スタディチェア:Alaa Elsayed Atia Hassan、10712023100273@stud.cu.edu.eg
- スタディチェア:Esraa Mohamed Mosaid、esramohamedmosaid@gmail.com
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- TECAR With SIS
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個々の参加者データ (IPD) を共有する予定はありますか?
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