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Vibrationsterapi og IASTM ved Subacromialt Impingement Syndrom

23. juli 2026 opdateret af: Emre DANSUK

Effekterne af vibrationsbehandling og instrumentassisteret blødvævsbehandling på smerte, bevægelighed, funktionalitet, ledpositionssans og livskvalitet hos personer med subakromialt impingementsyndrom

Denne randomiserede kontrollerede kliniske undersøgelse har til formål at undersøge effekterne af vibrationsterapi og instrumentassisteret blødvævsmanipulation (IASTM), når de tilføjes til konventionel fysioterapi, på smerter, bevægelsesområde, proprioception, funktionel status og livskvalitet hos personer diagnosticeret med subakromialt impingementsyndrom (SAIS). SAIS er en af de hyppigste årsager til skuldersmerter og er ofte forbundet med nedsat skapulær kinematik, rotator cuff-dysfunktion, blødvævsspændinger og reduceret skulderbevægelighed.

I alt 48 deltagere i alderen 40-60 år med MR-bekræftet SAIS vil blive tilfældigt tildelt tre grupper: (1) Vibrationsterapi + Konventionel Fysioterapi, (2) IASTM + Konventionel Fysioterapi og (3) Konventionel Fysioterapi (Kontrol). Alle interventioner vil blive administreret tre gange om ugen i fire uger. Resultater inkluderer smerteintensitet (VAS), skulderbevægelsesområde (Goniometer Pro app), proprioception ved 60° fleksion og abduktion, funktionel status (DASH) og livskvalitet (RC-QoL).

Undersøgelsen har til formål at afgøre, om tilføjelse af vibrationsterapi eller IASTM til standard fysioterapi giver yderligere kortsigtede fordele i form af reduktion af smerter, forbedring af ledbevægelighed, forøgelse af proprioceptiv skarphed og øget funktionel kapacitet hos personer med subakromialt impingementsyndrom.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Subacromialt impingement-syndrom (SAIS) er en af de hyppigst forekommende muskel- og skeletlidelser, der rammer cirka 20-30% af den generelle befolkning og udgør en væsentlig årsag til skuldersmerter. SAIS er blevet forbundet med ændret scapulær kinematik, muskelubalance i rotator cuff, stramhed i blødvæv, posturale abnormiteter og nedsat neuromuskulær kontrol. Konventionel fysioterapi – inklusive terapeutiske øvelser, stretching, elektroterapimodaliteter og manuelle teknikker – anvendes almindeligvis i klinisk praksis. Evidencen tyder dog på, at kombination af manuelle eller blødvævsbaserede interventioner med standard fysioterapi kan give mere effektive forbedringer i smerter, mobilitet og skulderfunktion.

Instrumentassisteret blødvævsmobilisering (IASTM) er en manuel terapeutisk teknik, der bruger ergonomisk designede rustfrit stål-værktøjer til at give kontrolleret mekanisk stimulation af blødvævet. IASTM har for nylig fået opmærksomhed på grund af dens evne til at øge blødvævets udstrækkelighed, fremme myofascial frigivelse og forbedre leddets bevægelighedsområde. Ligeledes er det vist, at vibrationsbaserede interventioner – inklusive perkussionsmassageterapi – forbedrer cirkulationen, reducerer smerter, mindsker muskelstivhed og forbedrer mobiliteten gennem mekanisk oscillation og stimulering af sensoriske receptorer. På trods af deres stigende popularitet findes der begrænset evidens vedrørende den direkte sammenligning af vibrationsterapi og IASTM hos personer med SAIS.

Dette randomiserede kontrollerede forsøg har til formål at evaluere, om tilføjelse af vibrationsterapi eller IASTM til konventionel fysioterapi giver bedre resultater sammenlignet med kun konventionel fysioterapi. I alt 48 voksne i alderen 40-60 år med MR-bekræftet SAIS vil blive tilfældigt fordelt i tre grupper: (1) Vibrationsterapi + Konventionel Fysioterapi, (2) IASTM + Konventionel Fysioterapi, og (3) Konventionel Fysioterapi (Kontrol). Alle interventioner vil blive udført tre gange om ugen i fire uger. Vibrationsterapi vil blive anvendt ved hjælp af en perkussionsmassageenhed (33 Hz) på deltoideus- og rotator cuff-musklerne langs origo-til-insertion-vejen. IASTM vil blive anvendt ved hjælp af standardiserede feje- og børsteteknikker i en 45° vinkel til både anteriore og posteriore skuldermuskelgrupper. Kontrolgruppen vil modtage konventionel fysioterapi bestående af ultralyd, TENS, kryoterapi, passiv stretching, Codman-øvelser, stavøvelser, fingerstigeøvelser og progressiv styrketræning, overvåget af en fysioterapeut.

Outcome-mål omfatter smerteintensitet (VAS), skulderens bevægelighedsområde målt med Goniometer Pro mobilapplikationen, proprioception vurderet ved 60° fleksion og abduktion, funktionel handicap evalueret ved hjælp af DASH-spørgeskemaet og skulderrelateret livskvalitet målt med RC-QoL-skalaen. Vurderingerne vil blive udført ved baseline og efter den 4-ugers interventionsperiode.

Denne undersøgelse søger at bidrage til den aktuelle litteratur ved direkte at sammenligne to hyppigt anvendte blødvævsinterventioner – vibrationsterapi og IASTM – inden for SAIS-befolkningen. Resultaterne forventes at informere klinikere om de potentielle ekstra fordele ved at kombinere disse modaliteter med konventionel fysioterapi for at optimere smertereduktion, funktionsforbedring og neuromuskulære resultater hos personer med subacromialt impingement-syndrom.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Inklusionskriterier:

  • Personer diagnosticeret med subacromialt impingement-syndrom bekræftet ved MR-scanning
  • Mænd og kvinder mellem 40 og 60 år
  • Tilstedeværelse af symptomer i mere end en måned

Eksklusionskriterier:

  • Tidligere operation på den påvirkede arm
  • Tilstedeværelse af et åbent sår på armen
  • Eksisterende infektion
  • Inflammatorisk ledlidelse
  • Skulderartrose
  • Tilstedeværelse af reumatisk sygdom
  • Maligne eller benigne tumorer
  • Uvilkår til at tolerere vibrationsterapi

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
Eksperimentel: Percussion Massage Therapy Plus Conventional Physiotherapy
Participants received the standardized conventional physiotherapy programme for four weeks and additionally received percussion massage therapy three times per week for four weeks.

Percussion massage therapy was administered using a handheld Hypervolt device (Hyperice, California, USA) at 33 Hz, corresponding to level 2 of the device. A flat-head attachment was used to provide uniform contact with the treated tissues.

The intervention was applied to the deltoid, supraspinatus, infraspinatus, and teres minor muscles along their anatomical fibre orientation. Each muscle was treated for three minutes using controlled longitudinal strokes applied alternately in proximal-to-distal and distal-to-proximal directions. The intervention was administered by the same licensed physiotherapist three times per week for four weeks, concurrently with the conventional physiotherapy programme.

Andre navne:
  • Hypervolt Percussion Massage Device

Participants received a standardized, supervised conventional physiotherapy programme for four weeks, administered five sessions per week by a licensed physiotherapist. Each session included transcutaneous electrical nerve stimulation applied to the symptomatic shoulder for 20 minutes at 100 Hz, followed by a structured exercise programme.

The exercise programme included wand-assisted active range-of-motion exercises for shoulder flexion, abduction, extension, internal rotation, and external rotation; Codman pendulum exercises; active and passive stretching; and finger ladder exercises. Progressive strengthening exercises using elastic resistance bands were performed for shoulder flexion, abduction, internal rotation, external rotation, and extension. Resistance was progressively adjusted according to pain severity, functional capacity, and treatment tolerance, while a standardized volume of 10 repetitions per set was maintained.

Eksperimentel: IASTM Plus Conventional Physiotherapy
Participants received the standardized conventional physiotherapy programme for four weeks and additionally received instrument-assisted soft tissue mobilization three times per week for four weeks.

Participants received a standardized, supervised conventional physiotherapy programme for four weeks, administered five sessions per week by a licensed physiotherapist. Each session included transcutaneous electrical nerve stimulation applied to the symptomatic shoulder for 20 minutes at 100 Hz, followed by a structured exercise programme.

The exercise programme included wand-assisted active range-of-motion exercises for shoulder flexion, abduction, extension, internal rotation, and external rotation; Codman pendulum exercises; active and passive stretching; and finger ladder exercises. Progressive strengthening exercises using elastic resistance bands were performed for shoulder flexion, abduction, internal rotation, external rotation, and extension. Resistance was progressively adjusted according to pain severity, functional capacity, and treatment tolerance, while a standardized volume of 10 repetitions per set was maintained.

Instrument-assisted soft tissue mobilization was administered to the deltoid, supraspinatus, infraspinatus, and teres minor muscles three times per week for four weeks. All applications were performed by the same licensed physiotherapist.

Standardized sweep and brush stroke techniques were applied at an approximate treatment angle of 45 degrees and in accordance with the anatomical fibre orientation of each muscle. For each muscle, 20 seconds of parallel strokes were followed by 20 seconds of perpendicular strokes using controlled sweeping movements. The intervention was provided in addition to the conventional physiotherapy programme.

Andre navne:
  • IASTM
Aktiv komparator: Conventional Physiotherapy
Participants received a standardized, supervised conventional physiotherapy programme five sessions per week for four weeks.

Participants received a standardized, supervised conventional physiotherapy programme for four weeks, administered five sessions per week by a licensed physiotherapist. Each session included transcutaneous electrical nerve stimulation applied to the symptomatic shoulder for 20 minutes at 100 Hz, followed by a structured exercise programme.

The exercise programme included wand-assisted active range-of-motion exercises for shoulder flexion, abduction, extension, internal rotation, and external rotation; Codman pendulum exercises; active and passive stretching; and finger ladder exercises. Progressive strengthening exercises using elastic resistance bands were performed for shoulder flexion, abduction, internal rotation, external rotation, and extension. Resistance was progressively adjusted according to pain severity, functional capacity, and treatment tolerance, while a standardized volume of 10 repetitions per set was maintained.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Shoulder Joint Position Sense Error
Tidsramme: Baseline and immediately after the 4-week intervention

Shoulder joint position sense was assessed using a digital goniometer at target positions of 60 degrees of shoulder flexion and 60 degrees of shoulder abduction. The affected shoulder was passively positioned at the target angle, and the participant was allowed up to 10 seconds to memorize the position. The arm was then returned to the neutral position, and the participant was asked to actively reproduce the target position with the eyes closed.

The absolute angular difference between the target position and the reproduced position was calculated in degrees. Three trials were conducted for flexion and three trials for abduction, and the mean absolute error for each direction was used in the analysis. Lower values indicate greater joint position sense accuracy.

Baseline and immediately after the 4-week intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Shoulder Range of Motion
Tidsramme: Baseline and immediately after the 4-week intervention
Active shoulder range of motion was measured in degrees using a digital goniometer under standardized assessment conditions. Shoulder flexion, abduction, internal rotation, and external rotation were assessed. Higher values represent greater shoulder range of motion.
Baseline and immediately after the 4-week intervention
Change in Resting and Activity-Related Shoulder Pain
Tidsramme: Baseline and immediately after the 4-week intervention
Resting and activity-related shoulder pain intensity were assessed separately using a 10-centimetre Visual Analog Scale. The scale was anchored by 0, indicating no pain, and 10, indicating the worst imaginable pain. Participants marked their pain intensity on the scale, and the distance from the zero anchor was measured in centimetres. Lower scores indicate lower pain intensity.
Baseline and immediately after the 4-week intervention
Change in Upper-Extremity Disability
Tidsramme: Baseline and immediately after the 4-week intervention
Upper-extremity disability was assessed using the Disabilities of the Arm, Shoulder, and Hand questionnaire. The questionnaire contains 30 items and generates a total score ranging from 0 to 100. Higher scores indicate greater upper-extremity disability, whereas lower scores indicate better function.
Baseline and immediately after the 4-week intervention
Change in Rotator Cuff-Related Quality of Life
Tidsramme: Baseline and immediately after the 4-week intervention
Rotator cuff-related quality of life was assessed using the Rotator Cuff Quality of Life questionnaire. The questionnaire contains 34 items covering physical symptoms, work, daily activities, social functioning, and emotional well-being. Scores are expressed on a scale from 0 to 100, with higher scores indicating better rotator cuff-related quality of life.
Baseline and immediately after the 4-week intervention

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Ledende efterforsker: Emre DANSUK, PhD, Medipol 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 (Faktiske)

10. december 2025

Primær færdiggørelse (Faktiske)

1. februar 2026

Studieafslutning (Faktiske)

15. februar 2026

Datoer for studieregistrering

Først indsendt

6. december 2025

Først indsendt, der opfyldte QC-kriterier

6. december 2025

Først opslået (Faktiske)

18. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • E-10840098-202.3.02-7891

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request to the corresponding author for scientifically sound research purposes. Data access will be subject to approval of the proposed use and completion of an appropriate data-sharing agreement, in accordance with institutional policies and applicable ethical requirements.

IPD-delingstidsramme

Beginning immediately after publication and available for five years.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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