Frozen Shoulder Treatment with IA Corticosteroid Injection and Suprascapular Nerve Block

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Brussel

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11], Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

2 Feb 2025 → ongoing

Decision date (initial)

2024-09-16

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513057-78-00

ClinicalTrials.gov

NCT06229964

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Diagnosis

The aim of this study is to determine if there is any difference in pain relief and function in patients with Frozen Shoulder when given an Gleno-Humeral (GH) IACI with a SSNB compared to an GH IACI with a sham SSNB.

In another part of the study, we will try to determine which set of clinical examination tests and/or MRI criteria has the best diagnostic accuracy in early-stage Frozen Shoulder.

Finally, we want to identify which patients will benefit most from GH IACI or the combination of GH IACI and SSNB. The results of this trial will help to guide clinical practice treating patients with FS and improve resource allocation.
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).

Secondary objectives 1

1. The key secondary endpoints of this study are: • An 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. • All secondary outcomes are: NPRS, SPADI at 6-12months, Constant-Murley Score, EQ-5D-3L, PROMIS-29 Upper Extremity v2.0 Physical Function, Shoulder ROM: abduction, anterior elevation, external rotation, Frozen Shoulder Clinical Tests, Shoulder Impingement Tests, Tampa Scale for Kinesiophobia, Pain Self-Efficacy Questionnaire, Global Rating of Change Score, Work Ability Index, work status, Healthcare service use, adverse effect, use of res-cue therapy Linear regression analysis will be performed to determine which clinical examination tests and/or MRI criteria, or which combination of, will have the best diagnostic accuracy in early phase Frozen Shoul-der. An exploratory prediction analysis will try to identify: - which physical examination tests, or which combinations of tests are correlated with MRI di-agnostic criteria and a more positive evolution of SPADI – NPR pain – shoulder ROM – RTW/WAI. - which patients benefit the most from the combined SSNB + IACI

Conditions and MedDRA coding

Adhesive Capsulitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Written informed consent to participate in the study must be obtained from the subject prior to initiation of any study-mandated procedure
2. 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.
3. Dutch or French speaking persons
4. Age ≥ 18 years
5. 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
6. Control subjects for the diagnostic accuracy part of the study protocol: Contralateral shoulder of Frozen Shoulder subjects

Exclusion criteria 15

1. Subjects with posttraumatic or postsurgical stiff shoulder syndrome
2. Subjects who have received prior SSNB in the homolateral shoulder
3. Subjects who have received an IACI in the homolateral shoulder in the 3 months before inclusion
4. History of trauma at the onset of symptoms
5. Subjects with rheumatologic or neurologic disease involving the shoulder
6. Subjects with cervical radiculopathy
7. Subjects with coagulation disorder or treatments with anticoagulants
8. Hypersensitivity to local anesthetics or MRI contrast agent
9. Inability to understand the study procedures
10. Psychiatric illness
11. Pregnancy
12. Systematic yeast infections
13. Hypovolaemia
14. Infections at the injection site
15. Medical history of malignant hyperthermia, major conductin disorders, acute cardiac de-compensation, shock conditions, convulsions

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Secondary endpoints 24

1. • An 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.
2. Pain - Numeric Pain Rating Scale (NPRS) [Time Frame: 4 weeks - 3months - 6months - 12months after the intervention]
3. SPADI [Time Frame: 4 weeks- 6 months - 12months after the intervention]
4. Constant - Murley score (CMS) [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
5. Health related quality of life, evaluated with the EuroQol EQ-5D 3L [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
6. PROMIS-29 Upper Extremity v2.0- Physical function [Time Frame: 4weeks - 3 months - 6 months - 12 months after the intervention]
7. Shoulder ROM in abduction, anterior elevation, external rotation [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
8. 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.
9. Distension Test in Passive External Rotation (DTPER): as described by Noboa et al. in 2015 in Revista Esponola De Cirurgia Ortopedica Y Traumatologia [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
10. 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]
11. Jobe Test 32: as described by Jobe et al. in 1982 in AJSM [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
12. 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]
13. Hawkins-Kennedy test 34: as described by Hawkins et al. in 1980 in AJSM [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
14. Tampa Scale for Kinesiophobia (TSK-11): [Time Frame: 4weeks - 3 months - 6months - 12months after the intervention]
15. Pain Self-Efficacy Questionnaire (PSEQ) [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
16. Global Rating of Change Score (GRoC) [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
17. Work Ability Index (WAI) [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
18. Work Status [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
19. Healthcare service use [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
20. Adverse effects [Time Frame: 4weeks - 3months - 6months - 12months after the intervention]
21. Use of rescue therapy [Time Frame: 3months - 6months - 12months after the intervention]
22. 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.
23. 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
24. Exploratory prediction analysis part III: Through regression analysis the investigators want to identify patients that benefit the most from the combined SSNB + IACI

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Brussel

Sponsor organisation

UZ Brussel

Address

Laarbeeklaan 101

City

Jette

Postcode

1090

Country

Belgium

Scientific contact point

Organisation

UZ Brussel

Contact name

Marc Schiltz

Public contact point

Organisation

UZ Brussel

Contact name

Marc Schiltz

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications