Methylprednisolone acetate for Adhesive capsulitis | Frozen shoulder

Inclusion criteria

• {"criterion_text":"- Written informed consent to participate in the study must be obtained from the subject prior to initiation of any study-mandated procedure\n- 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.\n- Dutch or French speaking persons\n- Age ≥ 18 years\n- Control subjects for the diagnostic accuracy part of the study protocol: Subjects suffering from shoulder pain that do not fulfill the diagnostic criteria of Frozen Shoulder\n- Control subjects for the diagnostic accuracy part of the study protocol: Contralateral shoulder of Frozen Shoulder subjects"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- The key primary endpoint is the change in shoulder-related disability 3 months after intervention vs control, assessed through a validated questionnaire the Shoulder Pain and Disability Index (SPADI).","definition_or_measurement_approach":"Change in shoulder-related disability at 3 months measured by the Shoulder Pain and Disability Index (SPADI), a validated questionnaire; comparison of intervention vs control at 3 months."}

Secondary endpoints

• {"endpoint_text":"- \tAn intermediary statistical analysis will be performed at 6 months. In case all 3 outcomes (disability, pain, shoulder stiffness) show non-superiority at 6m, the study will not be ex-tended to the 12-month time point.","definition_or_measurement_approach":"Interim analysis at 6 months with a predefined rule: if disability, pain and shoulder stiffness all show non-superiority at 6 months, the study will not be extended to 12 months."}
• {"endpoint_text":"- Pain - Numeric Pain Rating Scale (NPRS) [Time Frame: 4 weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Pain assessed using the Numeric Pain Rating Scale (NPRS) at 4 weeks, 3 months, 6 months and 12 months post-intervention."}
• {"endpoint_text":"- SPADI [Time Frame: 4 weeks- 6 months - 12months after the intervention]","definition_or_measurement_approach":"Shoulder Pain and Disability Index (SPADI) measured at 4 weeks, 6 months and 12 months."}
• {"endpoint_text":"- Constant - Murley score (CMS) [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Constant-Murley Score measured at 4 weeks, 3 months, 6 months and 12 months."}
• {"endpoint_text":"- Health related quality of life, evaluated with the EuroQol EQ-5D 3L [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"EQ-5D-3L administered at 4 weeks, 3 months, 6 months and 12 months to assess health-related quality of life."}
• {"endpoint_text":"- PROMIS-29 Upper Extremity v2.0- Physical function [Time Frame: 4weeks - 3 months - 6 months - 12 months after the intervention]","definition_or_measurement_approach":"PROMIS-29 Upper Extremity v2.0 Physical Function measure at 4 weeks, 3 months, 6 months and 12 months."}
• {"endpoint_text":"- Shoulder ROM in abduction, anterior elevation, external rotation [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Range of motion measurements (abduction, anterior elevation, external rotation) at 4 weeks, 3 months, 6 months and 12 months."}
• {"endpoint_text":"- Coracoid Pain Test (CPT): The pain severity approach and affected-unaffected approach of the instrument-assisted CPT, as described by Mertens et al. (2022) are used.","definition_or_measurement_approach":"Coracoid Pain Test using pain severity and affected-unaffected approaches per Mertens et al. (2022)."}
• {"endpoint_text":"- Distension Test in Passive External Rotation (DTPER): as described by Noboa et al. in 2015 in Revista Esponola De Cirugia Ortopedica Y Traumatologia [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"DTPER performed per Noboa et al. (2015) at specified follow-up time points."}
• {"endpoint_text":"- Strict passive GH abduction: The patient is seated upright in a chair to limit trunk extension, the scapula and acromion are blocked with one hand of the examiner, while the other hand slowly brings the patient’s arm in maximal abduction, while the patient’s elbow is maintained in 90° flexion. [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Strict passive glenohumeral abduction measured per described procedure at scheduled follow-ups."}
• {"endpoint_text":"- Jobe Test 32: as described by Jobe et al. in 1982 in AJSM [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Jobe Test per original description at follow-ups."}
• {"endpoint_text":"- Neer Test 33: as described by Neer et al. in 1983 in Clin Rel Orthop Res. [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Neer Test per original description at follow-ups."}
• {"endpoint_text":"- Hawkins-Kennedy test 34: as described by Hawkins et al. in 1980 in AJSM [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Hawkins-Kennedy test per original description at follow-ups."}
• {"endpoint_text":"- Tampa Scale for Kinesiophobia (TSK-11): [Time Frame: 4weeks - 3 months - 6months - 12months after the intervention]","definition_or_measurement_approach":"TSK-11 administered at 4 weeks, 3 months, 6 months and 12 months."}
• {"endpoint_text":"- Pain Self-Efficacy Questionnaire (PSEQ) [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"PSEQ administered at scheduled follow-ups."}
• {"endpoint_text":"- Global Rating of Change Score (GRoC) [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"GRoC collected at 4 weeks, 3 months, 6 months and 12 months."}
• {"endpoint_text":"- Work Ability Index (WAI) [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"WAI administered at scheduled follow-ups."}
• {"endpoint_text":"- Work Status [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Work status recorded at follow-ups."}
• {"endpoint_text":"- Healthcare service use [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Healthcare service utilization tracked at follow-ups."}
• {"endpoint_text":"- Adverse effects [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Adverse effects recorded throughout follow-up time points."}
• {"endpoint_text":"- Use of rescue therapy [Time Frame: 3months - 6months - 12months after the intervention]","definition_or_measurement_approach":"Use of rescue therapy assessed at 3, 6 and 12 months."}
• {"endpoint_text":"- Exploratory prediction analysis part I: Through regression analysis the investigators want to find out which factors predict I) SPADI score at 3 -6- 12 months follow-up, II) pain NPR level at 3-6-12 months, III) shoulder ROM (°) at 3-6-12 months and IV) return to work and WAI score at 3-6-12 months.","definition_or_measurement_approach":"Exploratory regression analyses to identify predictors of SPADI, NPRS, ROM and RTW/WAI at 3, 6 and 12 months."}
• {"endpoint_text":"- Exploratory prediction analysis part II: Through regression analysis the investigators want to identify which physical examination tests, or which combinations of tests are correlated with MRI diagnostic criteria and a more positive evolution of SPADI score – NPR pain score – shoulder ROM (°)– RTW/WAI score","definition_or_measurement_approach":"Regression analyses to correlate physical exam tests/combinations with MRI criteria and clinical outcomes."}
• {"endpoint_text":"- Exploratory prediction analysis part III: Through regression analysis the investigators want to identify patients that benefit the most from the combined SSNB + IACI","definition_or_measurement_approach":"Exploratory regression to identify subgroups who benefit most from combined suprascapular nerve block (SSNB) plus intra-articular corticosteroid injection (IACI)."}

Belgium

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

20-03-2025

Processing Time Days

198

Number Of Sites

1

Number Of Participants

156

Primary sponsor

Full Name

UZ Brussel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium