search
Back to results

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

Primary Purpose

Frozen Shoulder

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hidro
MUA
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital Clínic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hidro alone

Hidro + MUA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 19, 2021
Last Updated
August 4, 2021
Sponsor
Hospital Clinic of Barcelona
search

1. Study Identification

Unique Protocol Identification Number
NCT05001438
Brief Title
MUA's Efficacy in Frozen Shoulder in Patients Which Already Received an Hidrodilatation
Official Title
Aleatorized Prospective Study on the Eficacy of Movilization Under Anesthesia in Patients With Frozen Shoulder That Already Receive Treatment With Hidrodilatation.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hidrodilatation alone is as efective as Hidrodilatation + Movilization under anesthesia to treat the frozen shoulder
Detailed Description
"Frozen shoulder" disease is a pathological entity defined by the presence of a painful shoulder accompanied by restricted mobility. It affects 2% of the population with a slight predominance in women and the average age ranges between 40 and 60 years. The diagnosis of frozen shoulder is clinical and by exclusion; it presents with constant pain, especially at night, which increases on sudden mobilization, with restriction of at least two axes of shoulder mobility, especially external rotation and abduction. The initial treatment of these patients is always conservative and consists of the association of pharmacological treatment (analgesics and anti-inflammatory drugs) together with a specific rehabilitation program. However, in many cases recovery is not complete and many patients require additional more invasive treatments. Hydrodilation is a technique described in 1965 that consists of infiltrating 20-40 cc of serum into the glenohumeral joint to distend the joint capsule. In most cases, it is also associated with intra-articular corticosteroid and anesthetic infiltration to add an anti-inflammatory and anesthetic effect to joint distention. Several studies have shown good results with this treatment, however, many patients persist with pain and significant functional limitations despite this treatment. Joint Mobilization Under general Anesthesia (MUA) is a more invasive alternative therapeutic technique that consists of a controlled mobilization under general anesthesia to break the synovial adhesions and the joint capsule, with the objective of increasing the range of motion. Several studies have evaluated the effectiveness and safety of this treatment, considered today a valid option for the treatment of frozen shoulder refractory to more conservative treatment. Some studies have already compared the effectiveness of hydrodilatation with MUA as treatments for frozen shoulder. Jacob et al. demonstrated the same effectiveness between hydrodilatation and MUA, however, MUA reported a higher rate of iatrogenesis: hemarthrosis and lesions in the labrum, glenohumeral ligament or subscapularis ligament. However, there is no study evaluating the synergy of both techniques in the treatment of painful shoulder. The aim of the present study is to assess the clinical efficacy of the combination of hydrodilatation and MUA in patients with frozen shoulder and to compare it with hydrodilatation alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hidro alone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hidro + MUA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hidro
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
MUA
Intervention Description
Movilization under anesthesia
Primary Outcome Measure Information:
Title
Shoulder Pain and Dissability Index
Description
13 items completed by the patient on shoulder pain and function. A score of 0 indicates best 100 indicates worst
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GUILLEM CLARET, PhD
Phone
+34-932275500
Ext
5533
Email
guillemclaret@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GUILLEM CLARET, PhD
Organizational Affiliation
Specialty surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GUILLEM CLARET, Dr.
Phone
+34-932275500
Ext
5533
Email
guillemclaret@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The intention is to publish the study findings in an international journal of the specialty.
IPD Sharing Time Frame
Publication by 2023
IPD Sharing Access Criteria
Open access vs private peer reviewed journal

Learn more about this trial

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

We'll reach out to this number within 24 hrs