Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05001438
Other study ID # HCB/2021/0567
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2021
Est. completion date August 31, 2023

Study information

Verified date July 2021
Source Hospital Clinic of Barcelona
Contact GUILLEM CLARET, PhD
Phone +34-932275500
Email guillemclaret@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date August 31, 2023
Est. primary completion date August 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hidro
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.
MUA
Movilization under anesthesia

Locations

Country Name City State
Spain Hospital Clínic Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06181461 - Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis N/A
Recruiting NCT03676829 - Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis Phase 1/Phase 2
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT04747938 - Frozen Shoulder Treated by Energy Accumulator N/A
Recruiting NCT05979974 - High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder N/A
Completed NCT02169206 - Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position N/A
Enrolling by invitation NCT03861923 - Dry Needling for Shoulder Adhesive Capsulitis N/A
Completed NCT06391567 - Balance in People With Frozen Shoulder
Not yet recruiting NCT05956171 - The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder N/A
Completed NCT03320200 - A Central Nervous System Focused Treatment Approach for Frozen Shoulder N/A
Recruiting NCT04738253 - Correlation Between Ultrasonography Finding and Shoulder Range of Motion in Stroke Patients
Not yet recruiting NCT06129006 - Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder N/A
Completed NCT02944526 - The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial Phase 4
Recruiting NCT02283996 - Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment Phase 4
Completed NCT02006719 - Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder Phase 2
Completed NCT01483963 - AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder Phase 2
Completed NCT04369144 - Adding Vertical Correction to Scapular Recognition on Patients With Frozen Shoulder N/A
Completed NCT03951896 - Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder Early Phase 1
Completed NCT05993000 - Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial N/A
Completed NCT05372497 - Central Nervous System Focused Therapy in Frozen Shoulder N/A