Frozen Shoulder Treatment With Intra-Articular Corticosteroid Injection and Suprascapular Nerve Block

NCT06229964 | Recruiting DMC

• 1 other identifier: 23454_FROSTBLOCK
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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, double blinded randomized clinical trials using a combination of SSNB and IACI are rare. The primary objective of this study is to compare the effectiveness of a glenohumeral IACI combined with a SSNB, compared to a glenohumeral IACI combined with a sham SSNB. Outcome measures of interest are shoulder-related disability reported by the patients, shoulder pain and shoulder stiffness. These outcome parameters will be compared between both treatment arms with an intention-to-treat analysis. As key secondary objectives, the investigators aim to identify which physical examination tests, or combinations of those, are correlated with MRI diagnostic criteria and favor a more positive evolution. Finally, through predictive analysis the investigators will try to establish which patients benefit the most from the combined SSNB + IACI.

Conditions

Frozen Shoulder; Adhesive Capsulitis

Keywords

Frozen Shoulder; Adhesive Capsulitis of the Shoulder; Intra-articular corticosteroid injection; ultra-sound guided injection; suprascapular nerve block; Joint Diseases; Musculoskeletal Diseases; Bursitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Pain - Numeric Pain Rating Scale (NPRS)

  4 weeks - 3 months - 6 months - 12months after the intervention

• Shoulder Pain and Disability Index (SPADI)

  4 weeks- 6 months - 12months after the intervention

• Constant- Murley score (CMS)

  4weeks - 3 months - 6 months - 12 months after the intervention

• Health related quality of life, evaluated with the EuroQol

  4weeks - 3 months - 6 months - 12 months after the intervention

• PROMIS-29 Upper Extremity v2.0

  4weeks - 3 months - 6 months - 12 months after the intervention

Other Outcomes (4)

• Superiority analysis of shoulder-related disability, pain and shoulder stiffness at 6 months after start of enrolment.

  6 months after start of enrolment

• Exploratory prediction analysis: part 1

  18 months after inclusion

• Exploratory prediction analysis: part 2

  18 months after inclusion

Study Arms (2)

SSNB + IACI

ACTIVE COMPARATOR

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.

Other: SSNB + IACI

Short-acting SSNB + IACI

PLACEBO COMPARATOR

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.

Other: Sham SSNB + IACI

Interventions

SSNB + IACI OTHER

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 tissue irritability and guide physiotherapy and rehabilitation. Use of passive physiotherapy (cold, heat or electric therapies) to treat pain. Active and passive mobilization of the shoulder under the pain threshold, Maitland mobilization, stretch exercises such as: table slides, wall climbers. Use of affected upper limb in pain free Range-of-Motion (ROM) is tolerated and stimulated. Progressively increase time and frequency of Total-End-Range-Time (TERT) positions to increase ROM

Also known as: Usual care

SSNB + IACI

Sham SSNB + IACI OTHER

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 tissue irritability and guide physiotherapy and rehabilitation. Use of passive physiotherapy (cold, heat or electric therapies) to treat pain. Active and passive mobilization of the shoulder under the pain threshold, Maitland mobilization, stretch exercises such as: table slides, wall climbers. Use of affected upper limb in pain free Range-of-Motion (ROM) is tolerated and stimulated. Progressively increase time and frequency of Total-End-Range-Time (TERT) positions to increase ROM

Also known as: Usual care

Short-acting SSNB + IACI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Written informed consent to participate in the study must be obtained from the sub-ject prior to initiation of any study-mandated procedure

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

Related Publications (5)

• Schiltz M, Goudman L, Moens M, Nijs J, Hatem SM. The diagnostic value of physical examination tests in adhesive capsulitis: a systematic review. Eur J Phys Rehabil Med. 2023 Dec;59(6):724-730. doi: 10.23736/S1973-9087.23.07940-6. Epub 2023 Sep 22.

  PMID: 37737049 BACKGROUND

• Jump CM, Waghmare A, Mati W, Malik RA, Charalambous CP. The Impact of Suprascapular Nerve Interventions in Patients with Frozen Shoulder: A Systematic Review and Meta-Analysis. JBJS Rev. 2021 Dec 22;9(12). doi: 10.2106/JBJS.RVW.21.00042.

  PMID: 34936584 BACKGROUND

• Kelley MJ, Shaffer MA, Kuhn JE, Michener LA, Seitz AL, Uhl TL, Godges JJ, McClure PW. Shoulder pain and mobility deficits: adhesive capsulitis. J Orthop Sports Phys Ther. 2013 May;43(5):A1-31. doi: 10.2519/jospt.2013.0302. Epub 2013 Apr 30. No abstract available.

  PMID: 23636125 BACKGROUND

• Millar NL, Meakins A, Struyf F, Willmore E, Campbell AL, Kirwan PD, Akbar M, Moore L, Ronquillo JC, Murrell GAC, Rodeo SA. Frozen shoulder. Nat Rev Dis Primers. 2022 Sep 8;8(1):59. doi: 10.1038/s41572-022-00386-2.

  PMID: 36075904 BACKGROUND

• Schiltz M, Croes J, van Brabander L, Roggeman S, Goudman L, Moens M, Nijs J, Pouliart N, Forthomme B, Hatem SM. The FROSTBLOCK trial: Protocol for a randomized controlled trial of intra-articular corticosteroid injection with or without suprascapular nerve block in frozen shoulder. Trials. 2025 Sep 29;26(1):383. doi: 10.1186/s13063-025-09123-y.

  PMID: 41023761 DERIVED

MeSH Terms

Conditions

Bursitis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Marc Schiltz, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Schiltz, MD

CONTACT

+324777712; marc.schiltz@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients will receive 2 concomitant USG injections: first a SSNB than an IACA Control group : short-acting SSNB is performed with a short-acting local anesthetic (Linisol 2%). Intervention group : SSNB is performed with a long-acting anesthestic (Ropivacaine 2%) + 20-mg methylprednisolone acetate. Same injected volume (5ml) in sham and intervention group. The advantage of using a short-acting anesthetic as a sham injection instead of a saline, is that at the time of injection the patient may perceive the anticipated short effect of the anesthetic similar to the intervention SSNB. The care provider will be unaware of the type of SSNB of the allocation group. The outcomes assessor will be unaware of the type of SSNB of the allocation group. The investigator who administers the injections, will be unaware of the allocation. The investigational products will be prepared by the pharmacist according to a pre-defined co-variate constrained randomization key.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-center Randomized Parallel-group

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 29, 2024
• Study Start: February 28, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)