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Trial Radar IA
Lo studio clinico NCT06229964 (FROSTBLOCK) per Spalla congelata, Capsulite adesiva è 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.
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Frozen Shoulder Treatment with Intra-Articular Corticosteroid Injection and Suprascapular Nerve Block (FROSTBLOCK) 100 Randomizzato Doppio cieco

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 NCT06229964 (FROSTBLOCK) è uno studio interventistico per Spalla congelata, Capsulite adesiva, attualmente in arruolamento. Avviato il 1 febbraio 2025, prevede di arruolare 100 partecipanti. Sotto la guida di Universitair Ziekenhuis Brussel, dovrebbe concludersi entro il 31 maggio 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 19 febbraio 2025.
Sommario breve
Frozen shoulder remains a challenging disease to treat as pain and loss of range of motion can persist for many months or even years. This loss of function can have a severe impact on the patient's activities, participation and overall quality of life.

The use of ultrasound-guided (USG) suprascapular nerve blocks (SSNB) and/or intra-articular corticoid injections (IACI) has been supported by many studies. However, d...

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Descrizione dettagliata
Frozen Shoulder (FS) is common disease affecting 2 to 5% of the general population, with a higher prevalence in patients suffering from diabetes and thyroid dysfunction.It remains frustrating for patients and treating health care professionals as severe shoulder pain and loss of function can last for up to two years. 5-7 In the early stage, most patients identify the following symptoms: strong component of night pain...Mostra di più
Titolo ufficiale

A Double Blinded Randomized Controlled Trial (RCT) Exploring the Additional Effect of a Suprascapular Nerve Block in Combination with an Intra-Articular Corticosteroid Injection in Patients with Frozen Shoulder

Patologie
Spalla congelataCapsulite adesiva
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • FROSTBLOCK
  • 23454_FROSTBLOCK
Numero NCT
NCT06229964
Data di inizio (effettiva)
2025-02-01
Ultimo aggiornamento pubblicato
2025-02-19
Data di completamento (stimata)
2027-05-31
Arruolamento (previsto)
100
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Frozen Shoulder
Adhesive Capsulitis of the Shoulder
Intra-articular corticosteroid injection
ultra-sound guided injection
suprascapular nerve block
Joint Diseases
Musculoskeletal Diseases
Bursitis
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Comparatore attivoSSNB + IACI
Patients randomized to this arm will receive a SSNB (20-mg methylprednisolone acetate and 5-mL Ropivacaine 2mg/ml) than a IACI (40-mg methylprednisolone acetate and 1-mL Ropivacaine 2mg/ml). Rehabilitation/physiotherapy is considered standard of care.
SSNB + IACI
Usual care: All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria but is the physiotherapist's choice how to implement these guidelines in clinical practice. Patient education on home-exercises Monitoring of peak pain, at rest/night and after rehabilitation sessions using a Numeric-Pain-Rating-Scale (0-10) (NPRS) to evaluate t...Mostra di più
Comparatore placeboShort-acting SSNB + IACI
Patients randomized to this arm will receive a SSNB (5-mL Linisol 10mg/ml) than a IACI (40-mg methylprednisolone acetate and 1-mL Ropivacaine 2mg/ml) Rehabilitation/physiotherapy is considered standard of care.
Sham SSNB + IACI
Usual care: All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria but is the physiotherapist's choice how to implement these guidelines in clinical practice. Patient education on home-exercises Monitoring of peak pain, at rest/night and after rehabilitation sessions using a Numeric-Pain-Rating-Scale (0-10) (NPRS) to evaluate t...Mostra di più
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered index consisting of 13 items, divided into two subscales: 5 items for pain and 8 items for disability. It can be completed by patients in less than 5 min and has shown good reliability and construct validity in the assessment of shoulder impairments and in particular frozen shoulder. The score for each subscale is obtained by adding up all the individual subscale scores and dividing the result by the maximum subscale score. The normalized score is converted to a scale from 0 to 100, with 100 indicating no problems and 0 indicating serious problems.
3 months
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Pain - Numeric Pain Rating Scale (NPRS)
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It is the simplest and most commonly used pain rating scale and offers numerous advantages, including ease of administration and scoring, multiple response options, and no reported age-related difficulties in its use.
4 weeks - 3 months - 6 months - 12months after the intervention
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered index consisting of 13 items, divided into two subscales: 5 items for pain and 8 items for disability. It can be completed by patients in less than 5 min and has shown good reliability and construct validity in the assessment of shoulder impairments and in particular frozen shoulder. The score for each subscale is obtained by adding up all the individual subscale scores and dividing the result by the maximum subscale score. The normalized score is converted to a scale from 0 to 100, with 100 indicating no problems and 0 indicating serious problems.
4 weeks- 6 months - 12months after the intervention
Constant- Murley score (CMS)
The CMS is a composite scale divided into four sections: pain (15 points), activities of daily living (20 points), ROM (40 points) and strength (25 points) with a total score ranging from 0 (worst possible) to 100 (best possible). Patients were asked to verbally rate each parameter.
4weeks - 3 months - 6 months - 12 months after the intervention
Health related quality of life, evaluated with the EuroQol
The EQ-5D 3L is a generic measure of health-related quality of life developed by the EuroQol Group. It is a validated measurement of quality of life widely used in different pathologies. The questionnaire is made up of two parts. The first part is descriptive and uses five different dimensions to score quality of life. These five dimensions are mobility, self-care, activities of the daily life, pain/discomfort and anxiety/depression. There are five different answer possibilities within each dimension, i.e. "no problem", "slight problem", "moderate problem", "severe problem" and "unable to". This renders 3125 different answer possibilities. The second part uses a visual analogue scale (VAS) to score the current health status of the patient, ranging from zero to one hundred. Zero corresponds to death and one hundred corresponds to a (subjective) perfect health status.
4weeks - 3 months - 6 months - 12 months after the intervention
PROMIS-29 Upper Extremity v2.0
The nine-item Patient-Reported Outcomes Measurement Information System (PROMIS)- Upper Extremity short form has been validated against different legacy PROM and general health scores. Item-levels are scored numerically for an individual's response to each question. PROMIS instruments are always expressed as a score relative to the mean of a group (T-score). The mean score in a population is assigned the value 50. The standard deviation is equal to 10 points. Higher scores (above the mean score) means more of the concept being measured.
4weeks - 3 months - 6 months - 12 months after the intervention
Shoulder ROM in abduction, anteflexion, external rotation
Active and passive ROM in anterior elevation, abduction and external rotation are measured using an adapted (large, total length 50cm) goniometer, as described by Riddle et al. and Sabari et al., and values were expressed in degrees °.
4weeks - 3 months - 6 months - 12 months after the intervention
Tampa Scale for Kinesiophobia (TSK-11):
A shortened version of the original 17-item TSK, that measures the extent to which a person believes that physical activity or movement may lead to (re)-injury. Patients rate each item on a four-point Likert scale, with scoring alternatives ranging from "strongly disagree" to "strongly agree". Scores range from 11 to 44 with a higher score reflecting greater pain-related fear.
4weeks - 3 months - 6 months - 12 months after the intervention
Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item scale which assesses a person's confidence in the ability to perform a task or activity, despite the pain. Each item is scored on a seven-point Likert scale (from "not at all confident" to "completely confident"). The total score ranges from 0 to 60 with a higher score representing greater pain self-efficacy beliefs.
4weeks - 3months - 6 months - 12 months after the intervention
Global Rating of Change Score (GRoC)
The Global Rating of Change Score (GRoC) is a frequently used outcome measure that is used independently to measure improvements in a patient's condition or as an anchor for other outcomes measures. On 11-point Likert scale participants rate the clinical course of their condition since the start of the treatment: from -5 "a great deal worse" to +5 "a great deal better" with 0 being "no change".
4weeks - 3months - 6 months - 12 months after the intervention
Work Ability Index (WAI)
The Work Ability Index (WAI) measures the work ability considering physical and mental parts of work as well as different diseases and their impact on work ability. It's a 10 items questionnaire concerning current work ability compared with the lifetime best, work ability in relation to the job demands, number of current diseases diagnosed by a physician, estimated work impairment due to diseases, sick leave, self-prognosis of work ability and mental resources. A given answer to a question earns points. The sum of all these points results in the WAI score, which ranges from 7 to 49 points. The score indicates the extent to which the individual's capabilities and the job requirements are consistent with each other, a higher score indicating a better match between capabilities and job requirements.
4weeks - 3months - 6 months - 12 months after the intervention
Work Status
Work status: Health economic assessment: As the investigators expect subgroups of Frozen Shoulder to be unable to work, subjects will be questioned if they are incapacitated to work due to Frozen Shoulder during baseline assessments. Once the symptoms and function improve, the investigators expect patients to be able to return to work.
4weeks - 3months - 6 months - 12 months after the intervention
Health care service use
Patients will keep a diary to log usage of pain medication and physiotherapy visits
4weeks - 3months - 6 months - 12 months after the intervention
Adverse effects
At every patient study contact, the occurrence or not of adverse affects will be recorded.
4weeks - 3months - 6 months - 12 months after the intervention
Rescue therapy
As this is a pragmatic trial, patients will be offered rescue therapy, consisting of an USG SSNB + IACI in their affected shoulder, every 3 months after inclusion, with a maximum of 3 interventions in 12 months
3months - 6months - 12months after the intervention
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • Written informed consent to participate in the study must be obtained from the subject prior to initiation of any study-mandated procedure
  • Suffering from Frozen Shoulder, defined as: Frozen shoulder is a self-limiting disease characterized by pain and functional restriction in both active and passive shoulder motion lasting more than 1 month, for which radiographic findings of the shoulder joint are unremarkable.
  • Dutch or French speaking persons
  • Age ≥ 18 years

  • Subjects with posttraumatic or postsurgical stiff shoulder syndrome
  • History of trauma at the onset of symptoms
  • Subjects with rheumatologic or neurologic disease involving the shoulder
  • Subjects with cervical radiculopathy
  • Coagulation disorder
  • Hypersensitivity to local anesthetics or MRI contrast agent
  • Inability to understand the study procedures
  • Psychiatric illness
  • Pregnancy
  • Subjects who have received prior SSNB in the homolateral shoulder
  • Subjects who have received an IACI in the homolateral shoulder in the 3 months before inclusion• Systematic yeast infections
  • Hypovolaemia
  • Infections at the injection site
  • Medical history of malignant hyperthermia, major conduction disorders, acute cardiac decompensation, shock conditions, convulsions

Control subjects for the diagnostic accuracy part of the study protocol

  • Inclusion criteria:
  • Written informed consent to participate in the study must be obtained from the sub-ject prior to initiation of any study-mandated procedure
  • Subjects suffering from shoulder pain that do not fulfill the diagnostic criteria of Frozen Shoulder
  • Dutch or French speaking persons
  • Age ≥ 18 years
  • Contralateral shoulder of Frozen Shoulder subjects
  • Exclusion criteria
  • Subjects with posttraumatic or postsurgical stiff shoulder syndrome
  • History of trauma at the onset of symptoms
  • Subjects with rheumatologic or neurologic disease involving the shoulder
  • Subjects with cervical radiculopathy
  • Coagulation disorder or treatments with anticoagulants
  • Hypersensitivity to MRI contrast agent
  • Inability to understand the study procedures
  • Psychiatric illness
  • Pregnancy
  • Systematic yeast infections
  • Hypovolaemia
  • Infections at the injection site
  • Medical history of malignant hyperthermia, major conductin disorders, acute cardi-ac decompensation, shock conditions, convulsions
Universitair Ziekenhuis Brussel logoUniversitair Ziekenhuis Brussel
Contatti principali dello studio
Contatto: Marc Schiltz, MD, +324777712, [email protected]
1 Centri dello studio in 1 paesi
Universitair Ziekenhuis Brussel, Brussels, 1090, Belgium
Marc Schiltz, MD, Contatto, [email protected]
In arruolamento