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.
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.
- Conditions
- Neck, Shoulder and Arm Syndrome
- 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 group | Role | What 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.
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.
- First posted29 Apr 2020
- Study start12 Jan 2013
- Primary completion12 Jan 2019
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck, Shoulder and Arm SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lipina Marina Mikhailovna, I.M. Sechenov First Moscow State Medical University
- Investigators
- Alexey V Lychagin, MD, PhD, Study chair, IM Sechenov UniversityEugene B Kalinsky, MD, PhD, Principal investigator, IM Sechenov University
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck-shoulder Pain - is it Possible to Use Commonly Used Provocative Tests and Functional Scores for Evaluation? Large Scale Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04366570
- Acronym / sponsor ID
- NSP / 07-18
- Conditions
- Neck, Shoulder and Arm Syndrome
- Keywords
- neck, shoulder, cervical spine, sagittal balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,402 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 12 Jan 2013 (actual)
- Primary completion
- 12 Jan 2019 (actual)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The 1st group | – | Other: clinical assessment of the shoulder and the cervical spine includes stress guideline tests(n=511; 36,45%) included patients with extra-articular injury of the proximal humerus (rotator cuff tear, anatomical and surgical neck fracture) |
| The 2nd group | – | Other: clinical assessment of the shoulder and the cervical spine includes stress guideline tests(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) |
| The 3rd group | – | Other: clinical assessment of the shoulder and the cervical spine includes stress guideline tests(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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- previous spine injuries and diseases; combined distal and midshaft humerus fractures; patients unwilling to participate to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical assessment of the shoulder and the cervical spine includes stress guideline testsAs a result of statistical processing, we are planning to obtain the most sensitive and specific tests from the clinical examination protocol | Other | The 1st group, The 2nd group, The 3rd group |
Primary outcome
correlation between shoulder girdle injury (and its treatment) and NSP in patients without previous pathology
Time frame: 1-2 years after injury
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
Related trials for Neck, Shoulder and Arm Syndrome
Recruiting
Core Stability vs Scapular Stabilization on Hand Grip Strength in Chronic Myofascial Neck Pain
Myofascial Neck Pain, Hand Grip Strength
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey V Lychagin, MD, PhD study chair
IM Sechenov University
Eugene B Kalinsky, MD, PhD principal investigator
IM Sechenov University
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.