Clinical trial NCT03032432: A Dynamic Elastic Garment (DEG) in Patients With Rotator Cuff Tendinopathy
Official title: A Single-blinded Randomized Controlled Trial Comparing Patients Who Receive a Corticosteroid Injection for Nontraumatic Degenerative Rotator Cuff Tears or Tendinopathy and Scheduled Use of a Dynamic Elastic Garment to Patients Who Receive a Corticosteroid Injection Alone.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Rotator Cuff Tendinopathy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if patients with shoulder pain and MRI-confirmed rotator cuff tendinosis, will have their pain and function improved when treated with daily use of a dynamic elastic garment along with a corticosteroid injection, when compared to those patients who receive a corticosteroid injection alone. To our knowledge this is the first study to evaluate the use of a dynamic elastic garment on shoulders.

* Group A: Control group, will receive and ultrasound-guided corticosteroid injection alone.
* Group B: Intervention, ultrasound-guided corticosteroid injection and scheduled use of a dynamic elastic garment, by IntelliSkin.
* Group C: Intervention corticosteroid injection and scheduled use of a Dynamic elastic garment, by AlignMed Posture Shirt 2.0.

Up to 60 patients will participate and be randomized in this study, both male and female between the ages of 18 to 89 years of age. Subjects will complete a few forms; SF-36, ASES, Simple Shoulder test, these will take place at the initial visit and Then again at your 4 week and 6 week visit.

This is a single center study, investigator initiated. 60 subjects will participate in the study at Loma Linda University.

Detailed description: Shoulder pain is a common complaint with a reported prevalence of 7-26% in the general population(1). The most common etiology of shoulder pain in the primary care setting is rotator cuff disease (2-4), a term which encompasses several separate diagnoses. In an orthopaedic practice, rotator cuff disease includes tendinosis or tendinitis of the supraspinatus, infraspinatus, subscapularis, or teres minor tendons, subacromial impingement with or without bursitis, bicipital tendinitis, or a partial or complete rotator cuff tear. This study will specifically include patients with tendinosis or tendinitis of the rotator cuff, for which we will use the term rotator cuff tendinopathy.

There are myriad treatment options for rotator cuff tendinopathy; from conservative measures such as NSAIDs, corticosteroid injections, and physiotherapy to more invasive measures including arthroscopic decompression for subacromial impingement syndrome. While most orthopaedic surgeons will employ some combination of physiotherapy, NSAIDs, and corticosteroid injections for pain relief, the evidence supporting their efficacy in providing long-term pain relief and functional improvement is limited. Thus, there is clinical equipoise that exists when treating rotator cuff tendinopathy has led physicians to pursue other less traditional modalities. Some of these that have gained notoriety are hyperthermia, extracorporeal shock-wave treatment, electrotherapy modalities and more recently, non-elastic taping and elastic kinesiology taping.

Dynamic elastic garments are relatively new products which are being used to improve posture and provide shoulder and lumbar support. Abnormal scapular motion, particularly scapular protraction, has been shown to reduce the subacromial width and place undue strain on the rotator cuff. These garments utilize elastic bands placed in specific locations to provide postural support and proprioceptive feedback to the patient. This may help to restore normal shoulder kinematics and subsequently provide relief of shoulder symptoms.

Patients with MRI-confirmed tendinosis or tendinopathy of the rotator cuff will have improved shoulder pain relief and outcome scores when treated with scheduled use of a dynamic- elastic garment and a corticosteroid injection compared to those patients who receive a corticosteroid injection alone.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 to 89 years of age with MRI-confirmed tendinosis of the rotator cuff (supraspinatus, infraspinatus, subscapularis, or teres minor tendons) with pain on clinical examination
* Symptomatic, nontraumatic rotator cuff tears as confirmed on MRI

Exclusion Criteria:

* Traumatic onset of shoulder symptoms
* Evidence of symptomatic glenohumeral osteoarthritis (osteophytes on plain films with pain or stiffness on examination)
* Partial or complete rotator cuff tears
* Previous surgery on the affected shoulder
* History of rheumatoid arthritis or other systemic inflammatory disorder
* Use of immunosuppressive therapies in the last 6 months
* Inability to comply with or properly document use of dynamic elastic garment for prescribed time.

Primary outcomes:
measure: Short Form-36
timeFrame: 12 months
Secondary outcomes:
measure: Simple Shoulder Test
timeFrame: 12 months
Other outcomes:
measure: American Shoulder and Elbow Surgeons Shoulder Assessment (ASES)
timeFrame: 12 months
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Healthcare Department of Orthopaedic Surgery
state: California
Study officials:
affiliation: Loma Linda University
name: Nirav H Amin, MD
role: PRINCIPAL_INVESTIGATOR
References: