Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis

NCT06176248 | Recruiting

• 1 other identifier: PA23085*
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind interventional superiority study evaluating the efficacy of suprascapular nerve block in addition to conventional therapies for adhesive capsulitis. Adhesive capsulitis is a pathology that results in reduced shoulder mobility due to retraction of the periarticular capsule. It may be primary or secondary to traumatic or neurological events, or associated with diabetes in particular. The usual treatment includes re-education sessions to improve joint amplitude and restore shoulder mobility. In persistent forms, intra-articular injection of cortisone is combined with distension of the capsule with a local anaesthetic under radiographic control. In some countries, subscapular nerve block (reversible anaesthesia) is used to improve pain. The combination of arthrodistension and subscapular nerve block has never been performed to accelerate the healing process. The aim of this study is to compare the performance of these two procedures together against the reference technique alone on time to improvement with the number of patients improved at one month according to the Constant score. This score is used to assess shoulder pain and function, with a significant improvement above eight points.

Conditions

Adhesive Capsulitis

Outcome Measures

Primary Outcomes (1)

• Constant score

  The Constant score measured at inclusion and at 1 month in both groups. Calculation of the difference in score between the two times (minimum 0 - maxumum 100)

  1 month

Study Arms (2)

Block and arthrodistension

ACTIVE COMPARATOR

Drug: Triamcinolone Acetonide

Placebo and arthrodistension

PLACEBO COMPARATOR

Drug: saline solution

Interventions

Triamcinolone Acetonide DRUG

1 injection of local anaesthetic (5 ml levobupivacaine 2.5 mg/mL) opposite the subscapular nerve, under ultrasound control, in a lateral decubitus or sitting position. Subsequently, they underwent Xray-controlled arthrodistension by injection of 1 ml of Triamcinolone Acetonide, combined with 10 ml of visipaque 270 contrast medium and 5 ml of Xylocaine.

Block and arthrodistension

saline solution DRUG

intramuscular injection of 1 ml saline under ultrasound control under the same conditions as the experimental group. Subsequently, they will undergo Xray-controlled arthrodistension under the same conditions as the experimental group

Placebo and arthrodistension

Eligibility Criteria

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

You may qualify if:

• Patient treated for adhesive capsulitis corresponding to a loss of passive amplitude of more than 20° in external rotation elbow to body and/or abduction in relation to the contralateral shoulder.
• Patient over 18 years of age
• Patient covered by a social security scheme
• Presence of an accompanying person on the day of the procedure for the return trip
• Patient having signed the consent form to participate in the study

You may not qualify if:

• Patient protected by law
• Pregnant women
• Patient who has had shoulder surgery less than six months old
• Patient unable to undergo rehabilitation within one month of surgery
• Allergy to one of the products used (anesthetic, iodinated contrast medium)
• Neuro-orthopedic disorder hampering clinical recovery
• Hemostasis disorder contraindicating block (no discontinuation of anticoagulants according to SFAR recommendations, congenital hemostasis disorder)

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Triamcinolone Acetonide; Saline Solution

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Lois BOLKO

CONTACT

03 26 78 80 80; lbolko@chu-reims.fr

Jean Hugues SALMON

CONTACT

03 26 78 44 21; jhsalmon@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: December 19, 2023
• Study Start: October 11, 2024
• Primary Completion (Estimated): January 11, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)