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- Ensaio Clínico NCT07667998
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy (HILT)
19 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Estimado)
69
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: mahmoud shaaban, phd
- Número de telefone: 01001080842
- E-mail: shaabab.m@outlook.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
supraspinatous tendon thickness
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
pain intensity
Prazo: 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
Prazo: up to six weeks
|
the range of motion will be measured by electrogoniometer
|
up to six weeks
|
|
upper limb disability
Prazo: 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
Prazo: up to six weeks
|
supraspinatus muscle strength will be measured by handheld dynamometer
|
up to six weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Estimado)
30 de junho de 2026
Conclusão Primária (Estimado)
25 de abril de 2027
Conclusão do estudo (Estimado)
25 de abril de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
19 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de junho de 2026
Primeira postagem (Real)
25 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P.T.REC/012/006491
Informações sobre medicamentos e dispositivos, documentos de estudo
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