Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05641415
Other study ID # HUS/13564/2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 16, 2023
Est. completion date March 30, 2024

Study information

Verified date June 2024
Source University of Helsinki
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the Finnish Imaging of Shoulder study we will recruit 600 participants from a nationally representative general population sample. Participants aged 40 to 75 years will be invited to a clinical visit that includes assessment of general health, shoulder history and symptoms, and bilateral clinical examination and shoulder imaging (both plain radiography and MRI). We aim to assess the prevalence of abnormal imaging findings in both asymptomatic and symptomatic individuals and explore possible risk factors for abnormal imaging findings and shoulder symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 603
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - Ambulatory - Participation in the Health 2000 Survey - Informed Consent Exclusion Criteria: - Dementia - Terminal Cancer - Previous shoulder joint replacement - Contraindications for MRI

Study Design


Intervention

Other:
Imaging
MRI and x-ray of both shoulders

Locations

Country Name City State
Finland Helsinki University Helsinki

Sponsors (3)

Lead Sponsor Collaborator
University of Helsinki Finnish Institute for Health and Welfare, Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Ibounig T, Buchbinder R, Sillanpaa N, Ramo L, Toivonen P, Raatikainen S, Koskinen S, Harkanen T, Rissanen H, Czuba T, Paavola M, Jarvinen T, Taimela S; FIMAGE investigators. Concordance of shoulder symptoms and imaging findings: a protocol for the Finnish Imaging of Shoulder (FIMAGE) study. BMJ Open. 2023 Dec 28;13(12):e074457. doi: 10.1136/bmjopen-2023-074457. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Shoulder Magnetic Resonance Imaging (MRI) 3T bilateral shoulder MRI At baseline
Other Shoulder Radiography Plain radiographs (three projections) of both shoulders At baseline
Other Clinical Shoulder Examination The clinical examination will include measurement of height, weight, active and passive range-of-motion (ROM) of both shoulders using an inclinometer and isometric muscle strength of shoulder abduction, internal, and external rotation. In addition, we will perform special shoulder tests following a structured assessment protocol At baseline
Other Hospital Anxiety and Depression Scale (HADS) A self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. Each item is answered by the patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression (higher scores indicating a more severe disorder). At baseline
Other Pain Catastrophizing Scale (PCS) The PCS was developed to help quantify an individual's pain experience, asking about how they feel and what they think about when they are in pain. The PCS asks 13 questions on thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. PCS total scores range from 0 - 52. At baseline
Other Pain Self Efficacy Questionnaire (PESQ) The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain. High scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients. 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
Secondary EQ-5D-5L EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. At baseline
See also
  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