Aleatorized Prospective Study on the Eficacy of Movilization Under Anesthesia in Patients With Frozen Shoulder That Already Receive Treatment With Hidrodilatation.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Shoulder Pain and Dissability Index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Hidro alone
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.
Intervention: Hidro (Procedure)
Hidro + MUA
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: Hidro (Procedure)
Hidro + MUA
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: MUA (Procedure)
Outcomes
Primary Outcomes
Shoulder Pain and Dissability Index
Time Frame: 1 year
13 items completed by the patient on shoulder pain and function. A score of 0 indicates best 100 indicates worst
Secondary Outcomes
No secondary outcomes reported