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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade do Porto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shoulder Hydrodistention

    Procedure/Surgery

    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.

  • suprascapular nerve block

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Hydrodistension AloneActive comparator 1 intervention
Group B: Suprascapular Nerve Block Followed by Shoulder HydrodistensionExperimental treatment 2 interventions

Trial outcomes

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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