- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07667998
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy (HILT)
19 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Interventistico
Iscrizione (Stimato)
69
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: mahmoud shaaban, phd
- Numero di telefono: 01001080842
- Email: shaabab.m@outlook.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
supraspinatous tendon thickness
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
pain intensity
Lasso di tempo: 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
Lasso di tempo: up to six weeks
|
the range of motion will be measured by electrogoniometer
|
up to six weeks
|
|
upper limb disability
Lasso di tempo: 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
Lasso di tempo: up to six weeks
|
supraspinatus muscle strength will be measured by handheld dynamometer
|
up to six weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
30 giugno 2026
Completamento primario (Stimato)
25 aprile 2027
Completamento dello studio (Stimato)
25 aprile 2027
Date di iscrizione allo studio
Primo inviato
19 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
19 giugno 2026
Primo Inserito (Effettivo)
25 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P.T.REC/012/006491
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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