Neck-shoulder Pain. Large Scale Prospective Cohort Study

NCT04366570 | Unknown DMC

• 1 other identifier: 07-18
• Study Type: observational
• Target: 1,402
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to determine and statistically justify the correlation between shoulder girdle injuries and the development of neck-shoulder pain syndrome. The study enrolled 1402 patients with hospital-treated shoulder girdle injuries (with consequences of upper limb trauma). Detailed protocol and questionnaire for clinical examination after discharge from the hospital were conducted. The prevalence of neck-shoulder pain among patients was calculated. The diagnostic value (sensitivity and specificity) of tests used in the study was assessed.

Conditions

Neck, Shoulder and Arm Syndrome

Keywords

neck, shoulder, cervical spine, sagittal balance

Outcome Measures

Primary Outcomes (1)

• correlation between shoulder girdle injury (and its treatment) and NSP in patients without previous pathology

  To carry out these tasks, it seems important to define and statistically substantiate the connection between shoulder injuries and the development of NSP in patients without vertebrogenous pathology. Then to analyze the diagnostic value (sensitivity and specificity) of the most used and well known cervical and shoulder clinical tests and stress tests. Based on the data and the statistical distribution of results, identify the most used clinical types of NSP, and create a working classification of it.

  1-2 years after injury

Study Arms (3)

The 1st group

(n=511; 36,45%) included patients with extra-articular injury of the proximal humerus (rotator cuff tear, anatomical and surgical neck fracture)

Other: clinical assessment of the shoulder and the cervical spine includes stress guideline tests

The 2nd group

(n=309; 22,04%) included patients with intra-articular injury of the proximal humerus (contracture of the shoulder joint and shoulder instability, humeral head fracture, including Hill-Sachs lesion)

Other: clinical assessment of the shoulder and the cervical spine includes stress guideline tests

The 3rd group

(n=582; 41,51%) - patients with injury of subacromial (suprahumeral) space (soft tissue injury, acromioclavicular and sternoclavicular joint injury, diaphyseal and distal end clavicle fracture)

Other: clinical assessment of the shoulder and the cervical spine includes stress guideline tests

Interventions

clinical assessment of the shoulder and the cervical spine includes stress guideline tests OTHER

As a result of statistical processing, we are planning to obtain the most sensitive and specific tests from the clinical examination protocol

The 1st group; The 2nd group; The 3rd group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A total of 1402 consecutive patients (with consequences of upper limb trauma) - 1014 males (72,3%) and 388 females (27,7%) aged 18-60 years (mean 40,5 ± 3,8 years) referred for shoulder examinations in our musculoskeletal clinic since 2013 were included.

You may qualify if:

• male and female individuals aged 18 to 60 years old; the shoulder girdle injury at least 1 year ago plus surgical or conservative injury-related treatment; patients able and willing to actively participate to the necessary rehabilitation protocol and clinical and radiological procedures; signed an ethics committee reviewed and approved informed consent form.

You may not qualify if:

• previous spine injuries and diseases; combined distal and midshaft humerus fractures; patients unwilling to participate to the study

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Officials

• Alexey V Lychagin, MD, PhD

  IM Sechenov University

  STUDY CHAIR

• Eugene B Kalinsky, MD, PhD

  IM Sechenov University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 29, 2020
• Study Start: January 12, 2013
• Primary Completion: January 12, 2019
• Study Completion: September 1, 2022
• Last Updated: May 19, 2020

Record last verified: 2020-05