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Neck, Shoulder and Arm SyndromeNSPNCT04366570

Neck-shoulder Pain. Large Scale Prospective Cohort Study

An observational study of Neck, Shoulder and Arm Syndrome, run by I.M. Sechenov First Moscow State Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Neck, Shoulder and Arm Syndrome
What is being tested?
clinical assessment of the shoulder and the cervical spine includes stress guideline tests
How many people
1,402 participants
Where
No sites listed yet
Study dates
12 Jan 2013to 1 Sep 2022
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

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

About this study

Official title: Neck-shoulder Pain - is it Possible to Use Commonly Used Provocative Tests and Functional Scores for Evaluation? Large Scale Prospective Cohort Study

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.

Read the detailed description

The study's objective is to investigate and statistically justify the correlation between shoulder girdle injury (and its treatment) and NSP in patients without previous pathology.

Methods. Study design. This study was prospective, cohort, single center. 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.

The study was approved by the institutional Ethical Committee. Patient inclusion criteria: 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.

Patient exclusion criteria: previous spine injuries and diseases; combined distal and midshaft humerus fractures; patients unwilling to participate to the study.

Assessment methods. The patients were divided into 3 study groups according to localization of the injury.

The 1st group (n=511; 36,45%) included patients with extra-articular injury of proximal humerus (rotator cuff tear, anatomical and surgical neck fracture).

The 2nd group (n=309; 22,04%) included patients with intra-articular injury of proximal humerus (contracture of the shoulder joint and shoulder instability, humeral head fracture, including Hill-Sachs lesion) and 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).

Totally, surgical treatment was performed in 771 cases (55%) and 631 patients (45%) were given conservative treatment. 220 patients (28,5%) in group 1, 155 patients (20,1%) in group 2 and 396 patients (51,4%) in group 3 received surgery. Likewise, 291 patients (46,1%) in group 1, 154 patients (24, 4%) in group 2 and 186 patients (29,5%) in group 3 were treated conservatively.

Since in our research we examined patients who had late posttraumatic/postoperative complications, special scales, survey questionnaires, and physical examination were conducted. Methods were performed at three points of the study: 1 year, 1,5 years and 2 years after discharge from the hospital.

On the first point (1 year after discharge) physical examination of all the patients and questionnaire assessments were performed. In some cases, the questionnaires were conducted via mobile phone with the subsequent visit for physical examination. At 6-8 months after the first visit, the next point of the research was performed. The questionnaires used in point 1 were administered. The patients who demonstrated a decrease in questionnaire scales rates were invited for clinical re-examination 1,7-2,2 years after the injury.

Pain intensity was evaluated using the following scales: VAS (visual analogue scale), UCLA (University of California Los Angeles) and SPADI (The Shoulder Pain and Disability Index).

Humeral articulation function was evaluated using following scales: UCLA (University of California Los Angeles), SPADI (The Shoulder Pain and Disability Index) and DASH (Disabilities of the Arm, Shoulder and Hand).

Shoulder function was evaluated using following scales: UCLA (University of California Los Angeles), SPADI (The Shoulder Pain and Disability Index) and DASH (Disabilities of the Arm, Shoulder and Hand).

ODI (Oswestry Disability Index) and SF-36 (Short Form-36 Health Status Survey) were used for disability and life quality assessment, respectively.

We set commonly used clinical tests to conduct the protocol for shoulder joint and cervical spine investigation. To investigate the shoulder girdle a number of tests was performed: stress test, range of motion test, test for shoulder bursitis, test for shoulder instability, test for rotator cuff injury, tests for acromioclavicular joint and long head of the biceps tendon pathology, etc. Cervical spine examination included range of motion, flexibility, pain localization and sagittal balance assessment. As a result, the protocol consisted of 15 tests for examination of the shoulder girdle and 10 tests for assessment of the cervical spine: Test (T) 1 - rotation mobility test, Т2 - test of head rotation in maximum extension, Т3 - test of head rotation in maximum flexion, Т4 - percussion test, Т5 - O'Donoghue test, Т6 - cervical spine distraction test, Т7 - shoulder press test, Т8 - test of maximum compression of the intervertebral foramina Т9 - Jackson compression test, Т10 - intervertebral foramina compression test, Т11 - quick test of combined motion, Т12 - Codman sign, Т13 - long head of the biceps tendon speed test, Т14 - Dawbarn sign, Т15 - Jobe supraspinatus test, Т16 - Gerber's lift-off test, Т17 - supine Napoleon test (belly-press test), Т18 - teres test, Т19 - nonspecific supraspinatus test, Т20 - painful arc, Т21 - Neer impingement sign, Т22 - Dugas, Т23 - O'Brien active compression test, Т24 - apprehension test, Т25 - Gerber-Ganz anterior drawer test; each test was scored.

Being tested
clinical assessment of the shoulder and the cervical spine includes stress guideline tests
Keywords
neck, shoulder, cervical spine, sagittal balance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clinical assessment of the shoulder and the cervical spine includes stress guideline testsOther

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

Study groups in NCT04366570
Study groupRoleWhat they receive
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)
Receives: 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)
Receives: 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)
Receives: Other: clinical assessment of the shoulder and the cervical spine includes stress guideline tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1-2 years after injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start12 Jan 2013
  3. Primary completion12 Jan 2019
  4. Study completion1 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,402 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04366570
Sponsor's protocol ID
07-18
Acronym
NSP
Status last verified
May 2020
First submitted
26 Apr 2020
Last updated
19 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neck, Shoulder and Arm Syndrome, run by I.M. Sechenov First Moscow State Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

correlation between shoulder girdle injury (and its treatment) and NSP in patients without previous pathology (time frame: 1-2 years after injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.

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