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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

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

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.

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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