MUA's Efficacy in Frozen Shoulder in Patients Which Already Received an Hidrodilatation

NCT05001438 | Unknown DMC

• 1 other identifier: HCB/2021/0567
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hidrodilatation alone is as efective as Hidrodilatation + Movilization under anesthesia to treat the frozen shoulder

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Dissability Index

  13 items completed by the patient on shoulder pain and function. A score of 0 indicates best 100 indicates worst

  1 year

Study Arms (2)

Hidro alone

ACTIVE COMPARATOR

The patient receives the Hidrodilatation guided by ultrasonography under anesthetic blockage of the circumflex nerve and the supraescapular nerve. The hidrodilatation is achieved by insuflating the articulation with 2 cc of trigon depot + 10 cc 1% mepivacain + 11 cc saline serum.

Procedure: Hidro

Hidro + MUA

EXPERIMENTAL

The patient receives the Hidrodilatation guided by ultrasonography under anesthetic blockage of the circumflex nerve and the supraescapular nerve. The hidrodilatation is achieved by insuflating the articulation with 2 cc of trigon depot + 10 cc 1% mepivacain + 11 cc saline serum. After the Hidrodilatation the patient is sedated and then a Movilization of the glenohumeral joint is performed.

Procedure: Hidro; Procedure: MUA

Interventions

Hidro PROCEDURE

Guided by ultrasonography under anesthetic blockage of the circumflex nerve and the supraescapular nerve. The hidrodilatation is achieved by insuflating the articulation with 2 cc of trigon depot + 10 cc 1% mepivacain + 11 cc saline serum.

Hidro + MUA; Hidro alone

MUA PROCEDURE

Movilization under anesthesia

Hidro + MUA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with "frozen shoulder", defined as painful shoulder accompanied with a greater or lesser degree of restriction of mobility, especially in passive external rotation of at least 3 months of evolution. The diagnosis, according to the usual protocol of the unit, should include radiological images that rule out degenerative or necrotic pathology and the performance of an ultrasound or MRI to rule out associated pathology of the rotator cuff, which are already obtained in the usual clinical follow-up.
• Failure of conservative treatment after a period of 3 months.
• Acceptance and signature of informed consent.

You may not qualify if:

• Known allergies to corticosteroids
• Patients with frozen shoulder secondary to previous shoulder surgery.
• High-risk patients in need of anticoagulant treatments.
• Patients with previous shoulder fracture.
• History of joint infection.
• Active neoplastic process.
• Associated rheumatic pathology.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• GUILLEM CLARET, PhD

  Specialty surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GUILLEM CLARET, PhD

CONTACT

+34-932275500; guillemclaret@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 12, 2021
• Study Start: August 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2023
• Last Updated: August 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Publication by 2023
• Access Criteria: Open access vs private peer reviewed journal

Locations

ES (1)