- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07615920
HILT vs ESWT in Supraspinatus Tendinitis
25. mai 2026 oppdatert av: sami abdu akkur, Kafrelsheikh University
Comparative Effectiveness of High-Intensity Laser Therapy Versus Extracorporeal Shock Wave Therapy in Patients With Supraspinatus Tendinitis
This randomized controlled trial aims to compare the effectiveness of High-Intensity Laser Therapy (HILT) and Extracorporeal Shock Wave Therapy (ESWT) in patients with supraspinatus tendinitis.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
48
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: SAMI ABDU AKKUR, MASTER
- Telefonnummer: +966500433558
- E-post: pt.sami558@gmail.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:
- Male and female participants aged between 18 and 60 years.
- Clinically diagnosed supraspinatus tendinitis confirmed by ultrasound imaging.
- Shoulder pain duration greater than 3 months.
- Ability to understand and follow study instructions.
- Willingness to participate and provide informed consent.
Exclusion Criteria:
- Full-thickness rotator cuff tear.
- Previous shoulder surgery.
- Pregnancy.
- Neurological disorders affecting the upper limb.
- Corticosteroid injection within the previous 3 months.
- Shoulder fracture or dislocation.
- Systemic inflammatory diseases.
- Participation in other physical therapy programs during the study period
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 |
|---|---|
|
Aktiv komparator: Group A: HILT + Conventional PT
|
High-Intensity Laser Therapy (HILT) is an advanced electrotherapy modality that uses high-power laser energy to penetrate deep musculoskeletal tissues and stimulate biological healing processes.
The device emits laser wavelengths ranging between 808-1064 nm with high peak power output, allowing deeper tissue penetration compared to conventional low-level laser therapy.
HILT provides analgesic, anti-inflammatory, and biostimulatory effects through increasing local blood circulation, enhancing cellular metabolism, stimulating collagen synthesis, and promoting tissue regeneration.
The treatment is non-invasive, safe, and commonly used in musculoskeletal rehabilitation, particularly for tendinopathies and chronic pain conditions.
The conventional physical therapy program consisted of a combination of therapeutic exercises and physical therapy modalities aimed at reducing pain, improving shoulder range of motion, enhancing muscle strength, and restoring functional performance.
The program included hot pack application, Transcutaneous Electrical Nerve Stimulation (TENS), stretching exercises, range of motion exercises, strengthening exercises for the rotator cuff and scapular stabilizers, as well as a home exercise program.
Treatment sessions were conducted three times per week according to the patient's tolerance and clinical condition
|
|
Aktiv komparator: Group B: ESWT + Conventional PT
|
The conventional physical therapy program consisted of a combination of therapeutic exercises and physical therapy modalities aimed at reducing pain, improving shoulder range of motion, enhancing muscle strength, and restoring functional performance.
The program included hot pack application, Transcutaneous Electrical Nerve Stimulation (TENS), stretching exercises, range of motion exercises, strengthening exercises for the rotator cuff and scapular stabilizers, as well as a home exercise program.
Treatment sessions were conducted three times per week according to the patient's tolerance and clinical condition
Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive therapeutic modality that delivers high-energy acoustic waves to injured musculoskeletal tissues.
The device generates focused or radial shock waves that stimulate tissue healing, neovascularization, pain reduction, and cellular repair mechanisms.
ESWT is widely used in the management of tendinopathies, calcific disorders, and chronic musculoskeletal pain.
Treatment parameters typically include energy flux density, frequency, number of impulses, and treatment sessions.
The therapy is considered safe and effective, with minimal side effects
|
|
Aktiv komparator: Group C: Conventional Physical Therapy Only
|
The conventional physical therapy program consisted of a combination of therapeutic exercises and physical therapy modalities aimed at reducing pain, improving shoulder range of motion, enhancing muscle strength, and restoring functional performance.
The program included hot pack application, Transcutaneous Electrical Nerve Stimulation (TENS), stretching exercises, range of motion exercises, strengthening exercises for the rotator cuff and scapular stabilizers, as well as a home exercise program.
Treatment sessions were conducted three times per week according to the patient's tolerance and clinical condition
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity measured using Visual Analogue Scale (VAS).
Tidsramme: At baseline and immediately after 4 weeks of intervention
|
Pain intensity will be assessed using the Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
|
At baseline and immediately after 4 weeks of intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI)
Tidsramme: At baseline and immediately after 4 weeks of intervention
|
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index (SPADI).
The SPADI score ranges from 0 to 100, with higher scores indicating greater pain and disability.
|
At baseline and immediately after 4 weeks of intervention
|
|
Upper Extremity Function Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Tidsramme: Time Frame: Baseline and immediately after 4 weeks of intervention.
|
Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
DASH scores range from 0 to 100, with higher scores indicating greater disability.
|
Time Frame: Baseline and immediately after 4 weeks of intervention.
|
|
Shoulder Range of Motion Measured Using a Digital Goniometer
Tidsramme: Baseline and immediately after 4 weeks of intervention.
|
Shoulder range of motion (flexion, abduction, and external rotation) will be measured in degrees using a digital goniometer.
Higher values indicate greater shoulder mobility.
|
Baseline and immediately after 4 weeks of intervention.
|
|
Quality of Life Measured by the Short Form-36 Health Survey (SF-36)
Tidsramme: Baseline and immediately after 4 weeks of intervention.
|
Quality of life will be assessed using the Short Form-36 Health Survey (SF-36).
Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
|
Baseline and immediately after 4 weeks of intervention.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Yasmin Mohamed Mahmoud, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
- Studiestol: Mahmoud Mohamed Ewida, PHD, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
- Studieleder: Shaimaa Ramadan Eldeab, PHD, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
- Hovedetterforsker: Sami ABDU Akkur, MASTER DEGREE STUDENT, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
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)
1. august 2026
Primær fullføring (Antatt)
30. oktober 2026
Studiet fullført (Antatt)
30. desember 2027
Datoer for studieregistrering
Først innsendt
19. mai 2026
Først innsendt som oppfylte QC-kriteriene
25. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KFSIRB200-1036
Plan for individuelle deltakerdata (IPD)
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