Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Træningsterapi og ortoser ved lateral albuetendinopati: sammenlignende effekter

19. august 2026 opdateret af: Büşra Kültür, Istanbul University - Cerrahpasa

Undersøgelse af virkningerne af forskellige typer ortoser brugt som supplement til træningsterapi ved lateral albuetendinopati

Formålet med denne undersøgelse er at adressere uoverensstemmelserne i litteraturen ved at undersøge virkningerne af en underarms modkraftsbøjle og en håndledsskinne, der anvendes som supplement til træningsterapi, på smerter, funktionalitet og grebsstyrke hos personer diagnosticeret med lateral albuetendinopati, sammenlignet med dem, der modtager træningsterapi alene. Resultaterne sigter mod at give værdifuld indsigt i klinisk praksis ved at fremhæve rollerne af begge ortoser brug og motion i behandlingen af ​​lateral albuetendinopati.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne undersøgelse vil blive udført under tilsyn af Istanbul University-Cerrahpasa, Fakultet for Sundhedsvidenskab, Institut for Fysioterapi og Rehabilitering. Det er designet som et randomiseret kontrolleret forsøg og vil omfatte deltagere diagnosticeret med lateral albuetendinopati, som opfylder inklusionskriterierne og accepterer at deltage. Disse deltagere vil blive rekrutteret fra Ortopædisk og Traumatologisk Klinik i Basaksehir Cam og Sakura City Hospital. Deltagerne vil blive informeret om formålet, procedurerne og potentielle risici ved undersøgelsen, og skriftlige informerede samtykkeformularer vil blive indhentet efter forklaringen. Efter underskrivelsen af ​​de informerede samtykkeformularer vil deltagerne blive randomiseret i tre grupper:

  1. Øvelse + Modkraft Underarmsstøttegruppe
  2. Motion + Håndledsstøttegruppe
  3. Kun træningsgruppe (kontrolgruppe)

Alle deltagere følger en standard træningsprotokol. Øvelserne vil blive udført to gange om ugen i seks uger og vil omfatte et evidensbaseret kombineret træningsprogram bestående af isometriske, koncentriske og excentriske håndledsøvelser. Øvelserne starter i første omgang med frie vægte på 0,5-1 kg, afhængigt af patienten, med progression opnået gennem 0,5-1 kg vægttrin. For øvelser med elastik, vil modstandsprogression blive styret ved at vælge et bånd med højere modstandsniveau. Udover træningsterapien vil gruppe 1-deltagere bruge en modkraft underarmsbøjle, mens gruppe 2-deltagere vil bruge en håndledsbøjle.

Deltagerne vil blive vurderet før interventionen og i 6. og 12. uge. I alt 45 patienter diagnosticeret med "lateral albuetendinopati" af en speciallæge vil blive evalueret i undersøgelsen. Vurderinger vil omfatte:

Sociodemografiske karakteristika og klinisk status ved hjælp af en "Case Assessment Form" Smerteniveauer ved hjælp af "Numerical Pain Rating Scale (NPRS)" Gribstyrke og smertefri grebsstyrke ved hjælp af et "Digital Hand Dynamometer" Funktionelle niveauer ved hjælp af "Patient-Rated Tennis Albue Evaluation (PRTEE)" spørgeskema udviklet specifikt til lateral albuetendinopati Tilfredshed med interventionerne vha. "Global Rating of Change Scale." De indsamlede data vil blive analyseret ved hjælp af Statistical Package for the Social Sciences (SPSS) software.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Buyukcekmece
      • Istanbul, Buyukcekmece, Tyrkiet (Türkiye), 34500
        • Faculty of Health Sciences, Istanbul University - Cerrahpasa

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
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • er mellem 18 og 65 år,
  • At have en diagnose af unilateral lateral albuetendinopati,
  • At have mindst to af Thomsen, Maudley's, Mill's eller Cozen's positive test under klinisk undersøgelse,
  • Har oplevet symptomer i mindst 3 måneder,
  • Ikke at have en systemisk eller kronisk sygdom, der ville forhindre deltagelse i behandlingsprogrammet.

Ekskluderingskriterier:

  • En historie med traumer eller operation i den relevante albue og/eller håndled,
  • Tilstedeværelsen af ​​ortopædiske og/eller neurologiske problemer i halshvirvelsøjlen, skulderleddet eller håndleddet,
  • Deltagelse i et fysioterapi- og genoptræningsprogram for lateral albuetendinopati inden for de sidste 6 måneder,
  • Modtagelse af injektioner inden for de sidste 6 måneder,
  • Systemisk betændelse.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Exercise-Only Group
This was the exercise-only group, in which participants received an exercise program without any additional support or devices such as braces. This group was used to assess the effectiveness of exercise alone compared with other interventions involving braces. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group.
Andet: Exercise-Only Group
Participants in this group received a standardized exercise protocol. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. Participants were assessed at baseline, week 6, and week 12.
Aktiv komparator: Exercise + Forearm Counterforce Brace Group
This group received a combined treatment approach, including exercise therapy alongside the use of a forearm counterforce brace. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group.
Andet: Exercise + Forearm Counterforce Brace Group
Participants in this group received a standardized exercise protocol and a counterforce forearm brace in addition to exercise therapy. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. The counterforce forearm brace was positioned approximately 2.5 cm distal to the lateral epicondyle and was worn during daytime waking hours for 6 weeks. Participants were instructed to remove the brace during sleep and supervised exercise sessions. Participants were assessed at baseline, week 6, and week 12.
Aktiv komparator: Exercise + Wrist Orthosis Group
This group received a treatment combining exercise therapy with the use of a wrist orthosis. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group.
Andet: Exercise + Wrist Orthosis Group
Participants in this group received a standardized exercise protocol and a wrist orthosis in addition to exercise therapy. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. The wrist orthosis maintained the wrist in slight extension and was worn during daytime waking hours for 6 weeks. Participants were instructed to remove the orthosis during sleep and supervised exercise sessions. Participants were assessed at baseline, week 6, and week 12.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
Tidsramme: Baseline, week 6, week 12; primary endpoint = week 12
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a self-reported questionnaire designed to measure pain and functional limitations in individuals with lateral epicondylitis (tennis elbow). It consists of 15 items divided into two subscales: pain (5 items) and functional disability (10 items). Each item is rated on a scale from 0 (no pain or difficulty) to 10 (severe pain or difficulty), with a total score range of 0 to 100. Higher scores indicate greater pain and disability, while lower scores reflect improvement. The PRTEE is commonly used to assess treatment outcomes and track patient progress over time.
Baseline, week 6, week 12; primary endpoint = week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Resting Pain Intensity (Numeric Pain Rating Scale [NPRS])
Tidsramme: Baseline, week 6, week 12
The Numeric Pain Rating Scale (NPRS) is a subjective measure used to assess pain intensity. It is a 0-10 scale, where 0 indicates "no pain" and 10 represents "the worst pain imaginable." Patients are asked to rate their pain level at rest during the previous 24 hours based on this scale. A decrease in the NPRS score indicates an improvement or reduction in pain, while an increase suggests worsening pain. It is a simple and widely used tool for monitoring pain in clinical and research settings.
Baseline, week 6, week 12
Activity Pain Intensity (Numeric Pain Rating Scale [NPRS])
Tidsramme: Baseline, week 6, week 12
The Numeric Pain Rating Scale (NPRS) is a subjective measure used to assess pain intensity. It is a 0-10 scale, where 0 indicates "no pain" and 10 represents "the worst pain imaginable." Patients are asked to rate their pain level during activity based on this scale. A decrease in the NPRS score indicates an improvement or reduction in pain, while an increase suggests worsening pain. It is a simple and widely used tool for monitoring pain in clinical and research settings.
Baseline, week 6, week 12
Pain-Free Grip Strength
Tidsramme: Baseline, week 6, week 12
Pain-free grip strength is a measure of grip force that can be exerted without provoking pain. It was assessed using a digital hand dynamometer. Participants were instructed to gradually increase their grip force until they first experienced pain, and the grip force at that point was recorded. An increase in pain-free grip strength indicates an improvement in grip performance and pain tolerance.
Baseline, week 6, week 12
Maximum Grip Strength
Tidsramme: Baseline, week 6, week 12
Maximum grip strength is a measure of the maximum force that can be generated during a grip. It was assessed using a digital hand dynamometer. Participants were instructed to squeeze the dynamometer as strongly as possible, and the maximum grip force was recorded. An increase in maximum grip strength indicates an improvement in grip performance.
Baseline, week 6, week 12
Global Rating of Change (GRC)
Tidsramme: Week 6, week 12
The Global Rating of Change (GRC) scale is a subjective measure used to assess patients' perceived change in their condition following treatment. Participants compare their current condition with their condition before treatment and rate their perceived change. In this study, the GRC was used to assess patients' perceived recovery at weeks 6 and 12. For analysis, responses were categorized as unchanged, better, or much better.
Week 6, week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University - Cerrahpasa

Efterforskere

  • Ledende efterforsker: Büşra Kültür, MSc, Istanbul University - Cerrahpasa
  • Studieleder: Derya Çelik, Prof. Dr., Istanbul University - Cerrahpasa

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 (Faktiske)

2. december 2024

Primær færdiggørelse (Faktiske)

30. august 2025

Studieafslutning (Faktiske)

30. august 2025

Datoer for studieregistrering

Først indsendt

11. december 2024

Først indsendt, der opfyldte QC-kriterier

11. december 2024

Først opslået (Faktiske)

16. december 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IstanbulUC-FTR-B-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner