- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07667998
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy (HILT)
19. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Intervensjonell
Registrering (Antatt)
69
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: mahmoud shaaban, phd
- Telefonnummer: 01001080842
- E-post: shaabab.m@outlook.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
supraspinatous tendon thickness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
pain intensity
Tidsramme: 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
Tidsramme: up to six weeks
|
the range of motion will be measured by electrogoniometer
|
up to six weeks
|
|
upper limb disability
Tidsramme: 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
Tidsramme: up to six weeks
|
supraspinatus muscle strength will be measured by handheld dynamometer
|
up to six weeks
|
Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. juni 2026
Primær fullføring (Antatt)
25. april 2027
Studiet fullført (Antatt)
25. april 2027
Datoer for studieregistrering
Først innsendt
19. juni 2026
Først innsendt som oppfylte QC-kriteriene
19. juni 2026
Først lagt ut (Faktiske)
25. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P.T.REC/012/006491
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