Suprascapular Nerve Block to Improve Tolerance and Outcomes of Shoulder Hydrodistension in Adhesive Capsulitis

NCT07380087 | Not Yet Recruiting DMC

• 1 other identifier: FMUP/ULSSJ - 01/2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Adhesive capsulitis ("frozen shoulder") causes significant pain and loss of shoulder mobility. Shoulder hydrodistension is an established treatment that can improve movement and reduce symptoms, but the procedure itself may be painful and difficult for some patients to tolerate. This randomized clinical trial will evaluate whether performing a suprascapular nerve block with local anesthetic immediately before hydrodistension can reduce pain during the procedure, improve patient comfort, and potentially enhance clinical outcomes. Participants will be randomly assigned to one of two groups: hydrodistension alone, or suprascapular nerve block followed by hydrodistension. Pain, shoulder mobility, functional ability, psychological measures, and quality of life will be assessed at baseline, 1 month, and 3 months after the procedure. The study aims to determine whether adding a suprascapular nerve block provides better tolerability and improved recovery for patients with adhesive capsulitis.

Conditions

Adhesive Capsulitis; Adhesive Capsulitis, Shoulder; Frozen Shoulder; Shoulder Pain; Shoulder Stiffness; Adhesive Capsulitis of Unspecified Shoulder

Keywords

Shoulder Hydrodistension; Suprascapular Nerve Block; Shoulder Pain; Shoulder Mobility; Randomized Clinical Trial; Pain Management; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Shoulder Pain - Numeric Rating Scale for Pain (NRS 0-10)

  Shoulder pain intensity at rest and/or with movement will be measured using the Numerical Rating

  "From enrollment to the end of follow up at 3 years

Study Arms (2)

Hydrodistension Alone

ACTIVE COMPARATOR

Participants assigned to this arm will undergo standard ultrasound-guided shoulder hydrodistension without any prior nerve block. The procedure consists of an anterior intra-articular injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolone. This intervention represents the current standard treatment for adhesive capsulitis.

Procedure: Shoulder Hydrodistention

Suprascapular Nerve Block Followed by Shoulder Hydrodistension

EXPERIMENTAL

Participants in this arm will receive an ultrasound-guided suprascapular nerve block immediately before the hydrodistension procedure. The nerve block is performed at the suprascapular notch using 2 mL of ropivacaine. After the block, participants undergo standard anterior shoulder hydrodistension consisting of an intra-articular injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolone. This combined approach is intended to improve procedural tolerance and potentially enhance clinical outcomes in adhesive capsulitis.

Procedure: Shoulder Hydrodistention; Procedure: suprascapular nerve block

Interventions

suprascapular nerve block PROCEDURE

The suprascapular nerve block is performed under ultrasound guidance at the suprascapular notch using an injection of 2 mL of ropivacaine. The block is administered immediately before shoulder hydrodistension with the aim of reducing procedural pain and improving patient tolerance.

Also known as: Suprascapular Block, SSNB

Suprascapular Nerve Block Followed by Shoulder Hydrodistension

Shoulder Hydrodistention PROCEDURE

Shoulder hydrodistension is performed using an anterior intra-articular approach. The procedure consists of an injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolone into the glenohumeral joint, with the aim of capsular distension, pain reduction, and improvement of shoulder mobility.

Also known as: Hydrodilation, Glenohumeral Hydrodistension

Hydrodistension Alone; Suprascapular Nerve Block Followed by Shoulder Hydrodistension

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• Clinical diagnosis of adhesive capsulitis of the shoulder
• Persistent pain and functional limitation despite initial conservative treatment
• Ability to understand study procedures
• Ability to provide written informed consent

You may not qualify if:

• Known allergy or hypersensitivity to ropivacaine or methylprednisolone
• Active infection (local or systemic)
• Uncontrolled coagulopathy or ongoing therapeutic anticoagulation
• Recent surgery of the affected shoulder
• Neurological disease affecting the upper limb
• Pregnancy

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Unidade Local de Saude São João, EPE

Porto, Porto District, 4200-319, Portugal

Location

Related Publications (5)

• Sa Malheiro N, Afonso NR, Pereira D, Oliveira B, Ferreira C, Cunha AC. [Efficacy of ultrasound guided suprascapular block in patients with chronic shoulder pain: retrospective observational study]. Braz J Anesthesiol. 2020 Jan-Feb;70(1):15-21. doi: 10.1016/j.bjan.2019.11.001. Epub 2020 Feb 19.

  PMID: 32178894 BACKGROUND

• Goffin P, Forthomme B, Lecoq JP, Benmouna K, Kaux JF, Fontaine R. Evaluation of intensive rehabilitation under continuous suprascapular nerve blockade for the treatment of refractory adhesive shoulder capsulitis. Case series. Rev Esp Anestesiol Reanim (Engl Ed). 2022 Dec;69(10):625-631. doi: 10.1016/j.redare.2021.06.005. Epub 2022 Nov 4.

  PMID: 36344404 BACKGROUND

• Wang JC, Tsai PY, Hsu PC, Huang JR, Wang KA, Chou CL, Chang KV. Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis: A Randomized Controlled Trial Comparing the Posterior Glenohumeral Recess and the Rotator Cuff Interval Approaches. Front Pharmacol. 2021 May 7;12:686139. doi: 10.3389/fphar.2021.686139. eCollection 2021.

  PMID: 34025441 BACKGROUND

• Konarski A, Narayanasamy K, Coghlan J, Chung T, Andrews M, Bell S. A Double Blind Randomised Controlled Trial Comparing Glenohumeral Cortisone With and Without Hydrodilatation in Patients With Frozen Shoulder. ANZ J Surg. 2025 Oct;95(10):2162-2170. doi: 10.1111/ans.70200. Epub 2025 Jun 11.

  PMID: 40495621 BACKGROUND

• Brindisino F, Garzonio F, Turolla A, Andriesse A, Pulina F, Cucchi D, Struyf F, Venturin D. Perspectives, perceptions, and expectations of subjects with frozen shoulder: a web-based Italian survey. Arch Physiother. 2024 Dec 9;14:116-130. doi: 10.33393/aop.2024.3244. eCollection 2024 Jan-Dec.

  PMID: 39660343 BACKGROUND

MeSH Terms

Conditions

Bursitis; Shoulder Pain; Agnosia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Joao Manuel Rocha-Neves,, MD, MSc, MPH, PhD, MBA, FEBVS

CONTACT

910486230; joaorochaneves@hotmail.com

Joao Paulo Castro,, MD, MSc

CONTACT

+351914278223; joaofc22@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No participants, care providers, or outcome assessors are masked, and no additional masking procedures are used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, MPH, PhD, MBA, FEBVS

Model Details: This is a two-arm, parallel-group randomized clinical trial comparing hydrodistension alone versus suprascapular nerve block followed by hydrodistension in patients with adhesive capsulitis. Participants are allocated in a 1:1 ratio using a pre-generated randomization sequence. Both groups undergo a single intervention session, with outcomes assessed at baseline, 1 month, and 3 months.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: February 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)