Clinical trial NCT03303001: Comparison Between Subacromial Infiltrations
Official title: Subacromial Injection of High Volume Versus Conventional Steroid Injection Guided by Ultrasound in Shoulder Pain. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Bursitis
Subacromial Impingement Syndrome
Rotator Cuff Impingement Syndrome
Keywords: subacromial infiltration
high volumen
shoulder pain
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The shoulder pain is commonly seeing in orthopedic consultation. Many patients was affected in activities of daily living and in laborer absent. One of the first treatment lines is the steroid infiltration for pain relieve, however in several times is only effective by a short period of time, and the symptoms usually appear again. One of the not known infiltration is the high volumen infiltration in subacromial space, this treatment appears to be an effective treatment for this patients.

Detailed description: Shoulder pain is a common complaint in patients of all ages and activity levels, it is estimated that approximately 50% of the general population will experience at least one episode of shoulder pain over the course of a year. Shoulder pain has a general prevalence of 6.9-34%. The shoulder is the part of the upper extremity which is formed the proximal humerus, by the clavicle and the scapula, consisting in the shoulder griddle. The acromion is a bony process in the upper region of the scapula that articulates medially with the clavicle creating the acromioclavicular joint, at the same time forms the upper part of the shoulder joint. Between the humeral head and the acromion arch there is a space, the subacromial space, in which there are important structures for the proper functioning of the shoulder, among them, the subacromial bursa, the tendon of the rotator cuff and the tendon of the biceps brachii. The shoulder is the most mobile joint of all the body, therefore it is predisposed to suffer multiple injuries, including shoulder impingement syndrome, which has become one of the most frequent alterations of the musculoskeletal system. This pathology has an estimated prevalence of 43.7%. It is one of the most common causes of shoulder pain in the middle and advanced age patients.

Shoulder Impingement Syndrome is a condition in which structures in the subacromial space are chronically trapped between the humeral head and the acromion. It encompasses multiple conditions which includes partial rupture of the rotator cuff, rotator cuff tendinosis, calcified tendinitis or subacromial bursitis. All of these conditions may have a similar clinical picture and may be distinguishable by imaging of arthroscopy. The etiology of the syndrome is multifactorial, divided into extrinsic factors such as tendon overload, post trauma or repetitive microtraumas and intrinsic factors such as the vascularity of the tendon. There are also structural factors: anatomy of the acromion, subacromial osteophytes and acromioclavicular osteophytes; and functional factors: weakness of the rotator cuff, altered movement of scapula and ligament laxity increased. It is the result of a reduced space below the acromion. The most frequent clinical presentation will be insidious pain that can be installed in a period of days to months or after a trauma that can be irradiated to the side of the humerus. Usually the pain is nocturnal exacerbated by movements above the head or sleep on the affected shoulder and is attenuated by keeping the affected limb at rest.

Physical examination should assess muscular strength and ranges of motion. The general inspection should assess the presence of antalgic positions, muscular atrophy, asymmetries or sings of local inflammation. There is specific evidence for the evaluation of this pathology: Jobe's test, to evaluate de supraspinatus muscle, in which the patient is asked to perform 90° shoulder flexion, 30° abduction and external rotation and maintain the position against the shoulder resistance; Hawkins-Kennedy sign, for the subacromial impingement evaluation, with shoulder and elbow with 90° flexion perform rapid internal rotation of the shoulder, it is positive if it arouses with pain; Neer maneuver, for assessment of subacromial impingement, consists of the passive elevation of the extremity in abduction, flexion and internal rotation with stabilization of the scapula; Yocum´s maneuver, for assessment of subacromial impingement, the patient is asked to place the hand of the explored side in the contralateral shoulder and rises against resistance, it is positive if it causes pain. There are multiple differential diagnoses of this pathology, among which is adhesive capsulitis, cervical radiculopathy, glenohumeral instability, and acromioclavicular or glenohumeral osteoarthritis, among others.

The diagnosis is clinical and it is corroborated by imaging studies. Shoulder radiographs should be ordered in two positions to assess the morphology of the shoulder joint, to observe the distance between the humeral head to the acromion (11-14mm) and the evaluation of the acromioclavicular joint. Magnetic resonance imaging is the study of choice for evaluating shoulder impingement syndrome, where we will observe soft tissue structures that are part of the shoulder joint. Shoulder Impingement Syndrome is a pathology that causes pain and limitations to perform activities of daily living and evidence suggests that this condition is no self-limited, for this there are different alternatives of treatment. The aim of treatment is to decrease the pain and inflammation of soft tissues involved in the impingement in the subacromial space. Conservative treatment includes physical therapy, non-steroidal anti-inflammatory analgesics (NSAIDs) and subacromial infiltration. Surgical treatment includes shoulder arthroscopy to perform acromioplasty and thus release the subacromial space

Conservative Treatment

Physical Therapy Physical therapy is frequently implemented to reduce pain and improve shoulder function in this pathology. This must be carried out for at least six weeks. It includes cold-heat therapy, ultrasound, which has been shown to be of no benefit in the treatment of shoulder impingement and structural shoulder exercises, the aim of these treatment Is to reduce subacromial mechanical stress, to improve movement patterns and strengthening muscle fibers and thus prevent relapses, which have shown improvement in pain and function. Added to this it is recommended to avoid activities that are carried out above the head until the symptoms decrease.

Non-steroidal anti-inflammatory analgesics It is a frequent therapy in the treatment of this pathology. The effectiveness of NSAIDs in the treatment of shoulder impingement has not been demonstrated and potential complications have been observed with the use of long-term NSAIDs.

Shoulder Subacromial Injection It is a technique that consists of the direct application of an active principle in the subacromial space with the objective to suppress the inflammation and to diminish the pain. There are studies that show that there is a variation in the type and dose of steroids used in infiltration, in addition to that the number infiltrations also varied. Two studies conclude that there is an improvement in pain and range of motion with the use of this treatment.

Surgical Treatment Surgical treatment is indicated in patients who fail conservative treatment and continuous pain or in patients with complete rupture of the rotator cuff. Actually subacromial decompression with acromioplasty, osteophyte resection and bursectomy is performed by arthroscopy, in addition, to being able to observe the possible damage to the tendon of the rotator cuff, which, if present, can be repaired. It is currently mentioned that there is limited benefit with the conservative treatment established in the impingement syndrome, which is why new treatment options are being developed. A new treatment option is ultrasound-guided high-volume injection (HVIGI) in patients with shoulder impingement syndrome. Ultrasound-guided high-volume injection is a recent technique that involves injecting a high volume of fluid including a long-acting anesthetic and corticosteroids, guided by imaging (ultrasound). This technique has been used successfully and with good results in patellar tendinopathies, Achilles tendinopathies and subacromial impingement. High volume injection acts in different ways: breaks adhesions, stripping effect, stretch, has compression effect and also removes pain and promotes the healing of tendinopathy. Each injected component has different effect: the high volume breaks the adhesions, stretch and has drag effect; the long-acting anesthetic removes pain and the steroid prevents the formation of adhesions and promotes tendon healing

Eligibility criteria: Inclusion Criteria:

* Shoulder impingement syndrome
* Three months of history of pain and disability of the shoulder
* Failure to conservative initial treatment with NSAID's and rehabilitation

Exclusion Criteria:

* Rotator cuff tears
* Previous shoulder surgeries of any kind
* Glenohumeral or acromioclavicular arthritis
* Metabolic disease like diabetes mellitus or rheumatoid arthritis
* Previous infiltration in the past sixth months

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Three months
Secondary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Three months
measure: Simple Shoulder Test (SST)
timeFrame: Three months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon
state: Nuevo Leon
Study officials:
affiliation: Universidad Autonoma de Nuevo Leon
name: Carlos Acosta-Olivo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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