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- Essai clinique NCT07667998
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy (HILT)
19 juin 2026 mis à jour par: Mahmoud Mamdouh Ahmed Shaaban, Cairo University
This study will be conducted to investigate the difference between high-intensity laser and extracorporeal shock wave on supraspinatus tendon thickness, subacromial space, occupation ratio, shoulder pain intensity, shoulder range of motion (ROM), hand strength, and functional disability in patients with chronic supraspinatus tendinopathy.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
Supraspinatus tendinopathy is a common cause of shoulder pain and dysfunction due to irritation, inflammation, or degeneration of the supraspinatus tendon in the rotator cuff.
It is caused by repetitive overhead movements and is characterized by pain, weakness, and a limited range of motion, especially when reaching or lifting the arm.
Recently, studies have demonstrated that HILT is useful for treating a variety of shoulder impairments, including subacromial impingement syndrome, rotator cuff tendinopathy, and adhesive capsulitis.Shock wave is an effective and noninvasive method of reducing pain and increasing ROM and functional status without the need for surgery; it has been successfully utilized to treat tendinopathy over the past 20 years.There is a gap in available literature about comparing the high-intensity laser and extracorporeal shock wave in patients withchronic supraspinatus tendonitis.
So this study may add a piece of information to the physiotherapists in the government hospitals and the private clinics about showing the difference between the application of High Intensity laser and extracorporeal shock wave in patients with chronic supraspinatus tendinitis
Type d'étude
Interventionnel
Inscription (Estimé)
69
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: mahmoud shaaban, phd
- Numéro de téléphone: 01001080842
- E-mail: shaabab.m@outlook.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Patients from 18 to 50 years old of both genders.
- Unilateral Chronic Supraspinatus Tendinitis in dominant side
- BMI 18.5-24.9
- Tenderness is found over the supraspinatus as it passes subacromial and anterolateral The patient will report pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and overhead playing athletes)
- The patient will report pain with resisted isometric abduction.
- The patient will report positive Jobe's test (empty can test)
Exclusion Criteria:
- Post shoulder surgery, traumatic incidents
- Partial tears at surgery
- Massive retracted tears at surgery
- Frozen shoulder Rotator cuff tear
- Glenohumeral or acromioclavicular arthritis
- Implanted pacemaker
- Pregnancy
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: High-intensity Laser Therapy
Twenty-three patients with chronic supraspinatus tendinopathy will receive high-intensity laser and conventional physiotherapy twice a week for six weeks
|
the patients will receive HILT with peak power 3kW, intensity 15000W/cm and energy per pulse 350 mj) at supraspinatus tendenopathy.The treatment consisted of 3 phases in each session.
the initial phase will be rapid manual scanning (100 cm2/30s) of the anterior joint line of the shoulder with one shot of 850 mj at frequency of 30 Hz.
The scanning will be performed parallel to the joint line, with the patient arm internally rotated on the posterior scan and externally rotated on the anterior scan.
the intermediate phase will be a fixed scan phase , with one -shot emission of 350mj at a frequency of 20-25Hz.
plus conventional therapy
will receive Conventional physical therapy in form of stretching exercise of posterior shoulder capsule, passive stretching exercise, will be done only 3 times with holding time 30 sec and 10 sec rest period between repetitions , strengthing exercise consists of 3 exercises all have been recommended as essential for any shoulder rehabilitation program.
These exercise include shoulder flexion, scaption and horizontal extension.
for each exercise, a 10-repetition maximum for 3 sets with 60 sec rest between every set + TENS and hot back.
|
|
Expérimental: Extracorporeal Shock Wave
Twenty-three patients with chronic supraspinatus tendinopathy will receive extracorporeal shock wave and conventional physiotherapy twice a week for six weeks
|
will receive Conventional physical therapy in form of stretching exercise of posterior shoulder capsule, passive stretching exercise, will be done only 3 times with holding time 30 sec and 10 sec rest period between repetitions , strengthing exercise consists of 3 exercises all have been recommended as essential for any shoulder rehabilitation program.
These exercise include shoulder flexion, scaption and horizontal extension.
for each exercise, a 10-repetition maximum for 3 sets with 60 sec rest between every set + TENS and hot back.
patients will be sitting with shoulder abduction at 45 and elbow flexed and the forearm rested on flat surface and shock wave applicator directed in the most tender point near the insertion at the greater tubrosity under acromion with 2000 impulses, and energy flex density of 0.22mj/mm , pulse rate 10/sec and frequency 1-15 Hz plus conventional therapy
|
|
Comparateur actif: conventional therapy
Twenty-three patients with chronic supraspinatus tendinopathy will receive conventional physiotherapy twice a week for six weeks
|
will receive Conventional physical therapy in form of stretching exercise of posterior shoulder capsule, passive stretching exercise, will be done only 3 times with holding time 30 sec and 10 sec rest period between repetitions , strengthing exercise consists of 3 exercises all have been recommended as essential for any shoulder rehabilitation program.
These exercise include shoulder flexion, scaption and horizontal extension.
for each exercise, a 10-repetition maximum for 3 sets with 60 sec rest between every set + TENS and hot back.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
supraspinatous tendon thickness
Délai: up to 6 weeks
|
supraspinatus tendon thickness will be assess by ultrasonography.The tendon often appears swollen or thickened (frequently > 6 to 7 mm)
|
up to 6 weeks
|
|
supracromial space
Délai: up to 6 weeks
|
supracromial space will be measured by ultrasonography.
A normal resting subacromial space generally ranges from 9 to 11 mm.
A measurement of less than 6 mm is often pathological
|
up to 6 weeks
|
|
occupation ratio of subacromial space
Délai: up to 6 weeks
|
The ratio comparing the thickness of the supraspinatus tendon to the overall acromiohumeral distance.
An increased occupation ratio (i.e., a thickened tendon taking up too much of the space) indicates a higher risk of impingement
|
up to 6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
pain intensity
Délai: up to 6 weeks
|
visuala analogue scale will be used to assess pain intesity.
it is a line of 100 mm.The ends are labeled with extremes, such as "No pain" at 0 mm and "Worst pain imaginable" at 100 mm.
|
up to 6 weeks
|
|
shoulder range of motion
Délai: up to six weeks
|
the range of motion will be measured by electrogoniometer
|
up to six weeks
|
|
upper limb disability
Délai: up to six weeks
|
The QuickDASH will be used to assess upper limb function.the
QuickDASH is an 11-item questionnaire used to measure physical function and symptoms in people with upper limb disorders.
Scores range from 0 (no disability) to 100 (most severe disability).
|
up to six weeks
|
|
supraspinatus muscle strength
Délai: up to six weeks
|
supraspinatus muscle strength will be measured by handheld dynamometer
|
up to six weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 juin 2026
Achèvement primaire (Estimé)
25 avril 2027
Achèvement de l'étude (Estimé)
25 avril 2027
Dates d'inscription aux études
Première soumission
19 juin 2026
Première soumission répondant aux critères de contrôle qualité
19 juin 2026
Première publication (Réel)
25 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P.T.REC/012/006491
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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