Shoulder Pain Clinical Trial
Official title:
Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair: A Randomized Clinical Trial
Verified date | May 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Adults age 18-75 years old - Full thickness rotator cuff tears of any size (documented by MRI or ultrasound) - Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General Hospital/Bayview/Johns Hopkins Hospital operative sites) Exclusion Criteria: - Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes) - Patients undergoing revision rotator cuff tears will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Columbia | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score | 10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties). | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery | |
Secondary | Change in shoulder pain as assessed by Visual Analog Pain Score | Patients are asked to identify whether they are having pain in the shoulder and are asked to record the location of their pain on a 10 cm line that ranges from 0(no pain at all) to 10 (pain as bad as it can be) | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery | |
Secondary | Change in Range of Motion (ROM) | Total (combined glenohumeral and scapulothoracic) shoulder motion is measured. Both active and passive motion for both shoulders is recorded. Forward elevation is measured as the maximum arm-trunk angle viewed from any direction. External rotation is measured with the arm comfortably at the side and also with the arm at 90° of abduction. Internal rotation is measured by noting the highest segment of spinal anatomy reached with the thumb. Cross-body adduction is measured by measuring the distance of the antecubital fossa from the opposite acromion. | Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year | |
Secondary | Change in Strength Testing | Strength is graded according to the Medical Research Council grade. Strength is measured in forward elevation, abduction, external rotation with the arm comfortably at the side, and internal rotation with the arm comfortably at the side. A perfect score is a 5 in each category. | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery | |
Secondary | Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index | Quality of Life Measurement tool for patients with rotator cuff disease where patients mark a line on 21 visual analogue scale (VAS) lines labeled 0 (not affected) - 100 (affected). These items will ask about physical symptoms, sports and recreation, work, social function, and emotions. The maximum score is 2100 for worst possible symptoms and 0 represents no symptoms at all. | Before surgery, 1 year after surgery, 2 years after surgery | |
Secondary | Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D) | Measures of health related quality of life (HRQoL) using 11 items from the SF-36 or SF-12. Patients are asked about their physical functioning, role limitations, social functioning, pain, mental health, and vitality. A score of 1 represents full health. | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery | |
Secondary | Implant Cost | Review of costs through our billing department | Within 1 month after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04930393 -
Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients
|
N/A | |
Completed |
NCT03717753 -
Rotator Cuff Pathway
|
N/A | |
Completed |
NCT04454671 -
Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment
|
N/A | |
Completed |
NCT06274827 -
Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises
|
N/A | |
Not yet recruiting |
NCT05413213 -
Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder
|
N/A | |
Not yet recruiting |
NCT05043844 -
Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder
|
N/A | |
Recruiting |
NCT02903719 -
The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection.
|
Phase 4 | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Completed |
NCT02554968 -
Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
|
||
Recruiting |
NCT02242630 -
Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
|
N/A | |
Active, not recruiting |
NCT02843269 -
Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM
|
N/A | |
Completed |
NCT02631395 -
The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball
|
N/A | |
Completed |
NCT01733914 -
Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
|
Phase 2 | |
Completed |
NCT01885377 -
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
|
N/A | |
Completed |
NCT01205542 -
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function
|
N/A | |
Completed |
NCT01843660 -
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
|
Phase 4 | |
Completed |
NCT00743600 -
Ultrasound Evaluation of the Rotator Cable and Associated Structures.
|
N/A | |
Completed |
NCT00679887 -
Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points
|
Phase 1/Phase 2 | |
Completed |
NCT04058522 -
Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
|
N/A | |
Completed |
NCT03353272 -
The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
|
N/A |