- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07615920
HILT vs ESWT in Supraspinatus Tendinitis
25 maj 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
48
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: SAMI ABDU AKKUR, MASTER
- Telefonnummer: +966500433558
- E-post: pt.sami558@gmail.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain intensity measured using Visual Analogue Scale (VAS).
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: 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
- Studierektor: Shaimaa Ramadan Eldeab, PHD, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
- Huvudutredare: Sami ABDU Akkur, MASTER DEGREE STUDENT, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
30 oktober 2026
Avslutad studie (Beräknad)
30 december 2027
Studieregistreringsdatum
Först inskickad
19 maj 2026
Först inskickad som uppfyllde QC-kriterierna
25 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KFSIRB200-1036
Plan för individuella deltagardata (IPD)
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