- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07654790
ESWT vs HILT in Chronic Lateral Epicondylitis (ESWT vs HILT)
12. juni 2026 opdateret af: Mohammed Ali Saleh Alghamdi, Kafrelsheikh University
Effectiveness of Shockwave Therapy Versus High-Power Laser Therapy in the Management of Chronic Lateral Epicondylitis: A Double-Blind Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT) in patients with chronic lateral epicondylitis.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participants will be randomly assigned into three groups receiving either conventional physiotherapy alone, ESWT plus conventional physiotherapy, or HILT plus conventional physiotherapy.
Clinical assessments will be performed before and after treatment
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
72
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: mohammed ALI alghamdi
- Telefonnummer: =966538500550
- E-mail: pt.mohammedhajar@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:
• Age 40-50 years.
- Clinically diagnosed chronic lateral epicondylitis.
- Symptoms lasting more than 3 months.
- Positive clinical provocation tests.
- Localized tenderness over the lateral epicondyle.
Exclusion Criteria:
• Previous elbow surgery.
- Corticosteroid injection within the last 6 months.
- Cervical radiculopathy.
- Peripheral nerve entrapment.
- Rheumatologic or systemic inflammatory disorders.
- Elbow fracture.
- Severe elbow instability
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: Gruppe A
Konventionel fysioterapi
|
The conventional program will include TENS for twenty minutes in elbow region; the use of pulse ultrasound with duty cycle 80% on the lateral epicondyle for five minutes with an intensity of 0.8 W per every cm'; the use of ice for ten minutes; training for correcting the daily activities to minimize pressure on the elbow (preferentially, holding, lifting and pressing the objects will be asked to be carried out in supination); and, stretch and strain wrist muscle strengthening exercises (Fekri et al., 2019).
The exercise therapy method involved six elbow joint exercises.
They are a total of six exercises (Fig. 2) for patients with tennis elbow.
Each exercise will be performed three times a day, with each session involving five repetitions of the movement, over four weeks, gradually increasing weight until the movement is effective but below the pain threshold.
Painful movements will be avoided, and exercises causing pain or discomfort will be discontinued following consultation from a p
|
|
Aktiv komparator: Group B
ESWT + Conventional Physical Therapy
|
The conventional program will include TENS for twenty minutes in elbow region; the use of pulse ultrasound with duty cycle 80% on the lateral epicondyle for five minutes with an intensity of 0.8 W per every cm'; the use of ice for ten minutes; training for correcting the daily activities to minimize pressure on the elbow (preferentially, holding, lifting and pressing the objects will be asked to be carried out in supination); and, stretch and strain wrist muscle strengthening exercises (Fekri et al., 2019).
The exercise therapy method involved six elbow joint exercises.
They are a total of six exercises (Fig. 2) for patients with tennis elbow.
Each exercise will be performed three times a day, with each session involving five repetitions of the movement, over four weeks, gradually increasing weight until the movement is effective but below the pain threshold.
Painful movements will be avoided, and exercises causing pain or discomfort will be discontinued following consultation from a p
The Group will receive ESWT plus conventional physiotherapy treatment program.
Regarding ESWT protocol, the group will receive 1,000, 1,500, and 2,000 pulses during the first, second, and third through fifth treatments, respectively (pressure, 2.5 bar; frequency, 8 Hz; energy density, 0.4 mJ/mm2).
The patients received 5 ESWT treatments once per week.
The treatments were performed using a Rosetta ESWT (CR Technology, Korea).
Ultrasound gel was applied between the apparatus head and skin.
The procedure was performed in the area with the most intense pain.
Treatment was administered at the anterior aspect of the LE and three points around it at a radius of 1.5-2 cm.
The treatment time did not exceed 10 minutes.
During the treatments, the patients did not receive any drugs (Lizis, 2015).
|
|
Aktiv komparator: Group C:
HILT + Conventional Physical Therapy
|
The conventional program will include TENS for twenty minutes in elbow region; the use of pulse ultrasound with duty cycle 80% on the lateral epicondyle for five minutes with an intensity of 0.8 W per every cm'; the use of ice for ten minutes; training for correcting the daily activities to minimize pressure on the elbow (preferentially, holding, lifting and pressing the objects will be asked to be carried out in supination); and, stretch and strain wrist muscle strengthening exercises (Fekri et al., 2019).
The exercise therapy method involved six elbow joint exercises.
They are a total of six exercises (Fig. 2) for patients with tennis elbow.
Each exercise will be performed three times a day, with each session involving five repetitions of the movement, over four weeks, gradually increasing weight until the movement is effective but below the pain threshold.
Painful movements will be avoided, and exercises causing pain or discomfort will be discontinued following consultation from a p
The Group will receive HILT plus conventional physiotherapy treatment program.
High-power laser used in the present research paper was MLS Laser, Model M6 (ASA), that will be included in class four lasers device, with maximum 25-Watt power, average power of 3.3 Watts, wavelength of 808 nm in a continuous state.
The target region diameter in this device will be 5 cm and the energy used for treating the patients will be 272.4
Jules, and the energy density will be 13.89
Jules per cm' with a 700-hertz frequency for a period of three minutes on the lateral epicondyle and the origin of the wrist's extensor muscles (Fekri et al., 2019).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
1. Pain intensity measured using Visual Analogue Scale (VAS).
Tidsramme: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
|
2. Grip strength measured using Hand Dynamometer.
Tidsramme: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
|
3. Upper limb disability measured using QuickDASH Questionnaire.
Tidsramme: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
1. Pressure Pain Threshold using Algometer.
Tidsramme: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
|
2. Pinch Strength Measurement.
Tidsramme: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
|
3. Elbow Range of Motion (ROM).
Tidsramme: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
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4. Oxford Elbow Score (OES).
Tidsramme: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: MAHMOUD MOHAMMED EWIDA, PHD, Professor of Basic Sciences for Physical Therapy Department of Basic Sciences for Physical Therapy Faculty of Physical Therapy Kafrelsheikh University
- Studieleder: MOHAMMED FATHY ABDEL-GALIL, Lecturer of Basic Sciences for Physical Therapy Department of Basic Sciences for Physical Therapy Faculty of Physical Therapy Kafrelsheikh University
- Studieleder: HOSSAM MOHAMMED GAD, PHD, Professor of Orthopaedic Surgery Department of Orthopaedic Surgery Faculty of medicine Kafrelsheikh University
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)
1. april 2027
Datoer for studieregistrering
Først indsendt
12. juni 2026
Først indsendt, der opfyldte QC-kriterier
12. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KFSIRB200-1048
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