Shoulder Pain Clinical Trial
— FIMAGE-TOfficial title:
Finnish Imaging of Shoulder Trauma
The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Eligible participants of the FIMAGE study will be invited to a follow up visit in the case of a shoulder injury or a sudden onset of significant shoulder symptoms (within a 2-year time frame). These findings will then be compared to the baseline data collected in the FIMAGE study (including the comparison of pre-injury and post-injury MRI:s)
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Ambulatory - Participated in the FIMAGE - Baseline MRI from FIMAGE study available Exclusion Criteria: - Contraindications to MRI - Previous shoulder joint replacement - Previous rotator cuff surgery |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Central Hospital | Helsinki | |
Finland | Kuopio University Hospital | Kuopio | |
Finland | Tampere University Hospital | Tampere | |
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
University of Helsinki | Helsinki University Central Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Shoulder Examination | The clinical examination will include orthopaedic shoulder tests used to assess rotator cuff integrity (internal rotation lag sign, lift off, press belly, hornblower sign, bear hug test, drop arm sign, external rotation lag sign). | At baseline | |
Primary | Rotator Cuff Integrity on Shoulder Magnetic Resonance Imaging (MRI) | Bilateral shoulder MRI comparing the integrity of the rotator cuff tendons on pre-injury and post-injury MRI scans. Each of the four rotator cuff tendons (supraspinatus, infraspinatus, teres minor, subscapularis) will be assessed and graded for structural changes (normal, tendinopathy, partial thickness tear, full thickness tear). The dimensions of full thickness tears will be measured and recorded (size in millimeters). | At baseline | |
Primary | Shoulder Pain and Disability Index (SPADI) | Patient reported outcome measure. The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. A SPADI total score ranging from 0 (best) to 100 (worst) is produced by averaging the two subscale scores. | At baseline | |
Primary | Constant -Murley Score | The Constant-Murley Score was designed to assess the functional state of a shoulder and contains both physician- completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability). | At baseline | |
Secondary | Subjective Shoulder Value (SSV) | The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%. | At baseline | |
Secondary | Pain NRS | The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". | At baseline |
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 |
NCT01885377 -
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
|
N/A | |
Completed |
NCT01733914 -
Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
|
Phase 2 | |
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 |