beta
Trial Radar IA
Lo studio clinico NCT06494657 per Spalla congelata, Capsulite adesiva è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
Un studio corrisponde ai criteri del filtro
Vista a schede
Torna alla ricerca

Frozen Shoulder and Glucose Following Corticosteroid Injection 10

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06494657 è uno studio osservazionale per Spalla congelata, Capsulite adesiva, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 16 agosto 2024, con l'obiettivo di raggiungere 10 partecipanti. Sotto la guida di Central London Community Healthcare NHS Trust, dovrebbe concludersi entro il 30 aprile 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 13 agosto 2024.
Sommario breve

The goal of this clinical study is to look at what happens to blood sugar levels in people who have a frozen shoulder, who do not have diabetes after a corticosteroid injection in people with frozen shoulder.

  • The primary aim of this study will be to evaluate alterations in glucose levels for people without diabetes, following corticosteroid injection for frozen shoulder.
  • The secondary aims are to observe a range...
Mostra di più
Descrizione dettagliata
Frozen shoulder is regarded one of the most painful conditions to affect the shoulder. It is associated with substantial and prolonged pain that affects sleep and permeates into every aspect of daily function. Epidemiological research suggests the average onset is in the 6th decade, affecting up to 8% of men and 10% of women of working age may be affected. In people with diabetes this figure dramatically increases, w...Mostra di più
Titolo ufficiale

Frozen Shoulder: A Pragmatic Replicated N-of-1 Case Series Investigating Glucose Levels and Patient Reported Outcomes Following a Corticosteroid Injection.

Patologie
Spalla congelataCapsulite adesiva
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • RD24.001
Numero NCT
NCT06494657
Data di inizio (effettiva)
2024-08-16
Ultimo aggiornamento pubblicato
2024-08-13
Data di completamento (stimata)
2025-04-30
Arruolamento (previsto)
10
Tipo di studio
Osservazionale
Stato
Non ancora in arruolamento
Parole chiave
Corticosteroid
Injection
Hyperglycemia
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
N.D.
Iniezione di corticosteroidi
Corticosteroid injection for frozen shoulder
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Mean glucose levels
The primary biochemical outcome is mean glucose (mmol/dL) levels pre and post injection.
3 weeks
Shoulder Pain and Disability Index
The primary clinical outcome is the functional questionnaire 'Shoulder Pain and Disability Index' before and after the injection. The SPADI is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items), with the total score often described as a percentage, resulting from the summation of each component. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction.
3 weeks
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Quick Disabilities of the Arm, Shoulder, and Hand
The Quick Disabilities of the Arm, Shoulder, and Hand questionnaire is a subset of 11 items from the 30-item Disabilities of the Arm, Shoulder, and Hand and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
3 weeks
Pain Self Efficacy Questionnaire
The Pain Self Efficacy Questionnaire is a 10-item questionnaire, where patients rate their confidence from 0 points (not at all confident) to 6 points (completely confident). Total scores are calculated by summing the individual items with a range from 0 points (less self-efficacy) to 60 points (more self-efficacy)
3 weeks
Pittsburgh Sleep Quality Index
The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. In scoring the Pittsburgh Sleep Quality Index, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
3 weeks
Time in glucose range %
The time spent within various glucose ranges pre and post injection
3 weeks
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
45 Years
Sessi idonei
Tutti
  • Aged between 45 and 65
  • Without diabetes or pre-diabetes
  • Glenohumeral external rotation range is equally limited actively and passively by at least 50% compared to the contralateral side.

Other glenohumeral movements are equally limited actively and passively compared to the contralateral side in one or more additional planes of movement (such as hand behind the back/shoulder flexion/abduction/scaption).

  • The symptoms have been present for at least one month.
  • No significant abnormality on plain radiographs.
  • Ability to provide informed consent

  • Aged 44 and under and 66 and over
  • People with frozen shoulder secondary to significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) or other causes (e.g., recent breast cancer surgery or radiotherapy)
  • People with prediabetes, type 1 and 2 diabetes
  • A neurological disease affecting the shoulder
  • Evidence of other shoulder disorders (e.g., inflammatory arthritis, rotator cuff disorders, glenohumeral joint instability) or with red flags consistent with the criteria set out by British Elbow and Shoulder Society (Rangan, 2015).
  • Primary osteoarthritis of the glenohumeral joint on plain radiograph
  • Calcific tendinitis
  • Who have received corticosteroid injection for shoulder pain in the last 12 weeks
  • On long term steroids or a recent short course of oral steroids
  • Currently being treated with coumarin anticoagulants, such as warfarin
  • Who have participated in another research study involving an investigational medicinal product in the past 12 weeks
  • Significant renal or hepatic impairment
  • Any other significant disease which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
  • Systemically unwell or with infection
  • Pregnant or breastfeeding
Central London Community Healthcare NHS Trust logoCentral London Community Healthcare NHS Trust
University of Hertfordshire logoUniversity of Hertfordshire
Contatti principali dello studio
Contatto: Christine Bilsborough Smith, MSc, 07967631668, [email protected]
Contatto: Mindy Cairns, PhD, [email protected]
Nessun dato sulle località