- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07615920
HILT vs ESWT in Supraspinatus Tendinitis
25. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
48
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: SAMI ABDU AKKUR, MASTER
- Telefonnummer: +966500433558
- E-mail: pt.sami558@gmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- 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
- Ledende efterforsker: Sami ABDU Akkur, MASTER DEGREE STUDENT, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
30. oktober 2026
Studieafslutning (Anslået)
30. december 2027
Datoer for studieregistrering
Først indsendt
19. maj 2026
Først indsendt, der opfyldte QC-kriterier
25. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KFSIRB200-1036
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