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Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome

19. august 2021 opdateret af: Dr. Burcu Metin Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial

Shoulder pain, which is the third most common cause of musculoskeletal pain, has different etiologies. Muscle, bone structures and connective tissue pathologies can cause shoulder pain. Impingement syndrome (IS), which can cover many terms such as rotator cuff disorders, tendinitis and tears, is one of the most common pathologies of shoulder pain.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The hypothesis of this study was that injection types including ACJ would increase treatment efficacy.Therefore, this study investigated the six-month follow-up results of patients undergoing SA injection and SSNB and those receiving SA and ACJ injection.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Fase 4

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patients aged 18-65,
  • who were suffering from shoulder pain for more than three months and
  • who were diagnosed with IS.
  • All patients included in the study were diagnosed with IS using Shoulder Magnetic Resonance imaging.

Exclusion Criteria:

  • the presence of cervical radiculopathy;
  • undergoing shoulder operation before;
  • the presence of central nervous system or
  • the presence of rheumatological disease, and polyneuropathy;
  • receiving physical therapy in the shoulder area with a diagnosis of IS within the last six months; and
  • receiving any injection therapy in the past.

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: subacromial injection
ultrasound (US)-guided subacromial injection
Medicin: bupivacaine and methylprednisolone
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area
Medicin: bupivacaine and methylprednisolone
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area for the subacromial+acromioclavicular joint injection. In addition, 2 mL of 20 mg methylprednisolone and the same concentration of local anaesthetic were injected into the acromioclavicular joint
Medicin: bupivacaine and methylprednisolone
suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone
Andre navne:
  • supraskapulær nerveblok
Aktiv komparator: acromioclavicular joint and subacromial injection
ultrasound (US)-guided acromioclavicular joint and subacromial injection
Medicin: bupivacaine and methylprednisolone
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area
Medicin: bupivacaine and methylprednisolone
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area for the subacromial+acromioclavicular joint injection. In addition, 2 mL of 20 mg methylprednisolone and the same concentration of local anaesthetic were injected into the acromioclavicular joint
Medicin: bupivacaine and methylprednisolone
suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone
Andre navne:
  • supraskapulær nerveblok
Aktiv komparator: suprascapular nerve block
ultrasound (US)-guided suprascapular nerve block
Medicin: bupivacaine and methylprednisolone
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area
Medicin: bupivacaine and methylprednisolone
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area for the subacromial+acromioclavicular joint injection. In addition, 2 mL of 20 mg methylprednisolone and the same concentration of local anaesthetic were injected into the acromioclavicular joint
Medicin: bupivacaine and methylprednisolone
suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone
Andre navne:
  • supraskapulær nerveblok

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Analogue Scale (VAS)
Tidsramme: six month
for pain. 0: no pain at all, 10: worst pain imaginable
six month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Shoulder pain and disability index (SPADI)
Tidsramme: six month
This scale was developed to measure pain and disability associated with shoulder pain. It consists of two parts evaluating pain and disability.
six month
Short-Form 12 (SF-12)
Tidsramme: six month
The SF-12 has a physical (SF12-PCS) and mental (SF12-MCS) state assessment scale
six month

Samarbejdspartnere og efterforskere

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

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Efterforskere

  • Ledende efterforsker: Burcu Metin Ökmen, Assoc. Prof, University of Health Sciences, Yuksek Ihtisas Training and Research Hospital
  • Studiestol: Korgün M Ökmen, Assoc. Prof, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

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)

1. januar 2017

Primær færdiggørelse (Faktiske)

1. januar 2021

Studieafslutning (Faktiske)

1. januar 2021

Datoer for studieregistrering

Først indsendt

18. august 2021

Først indsendt, der opfyldte QC-kriterier

19. august 2021

Først opslået (Faktiske)

20. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BYİEAH2

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Skulderpåvirkning

Kliniske forsøg med bupivacaine and methylprednisolone

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