Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04366570 |
| Other study ID # |
07-18 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 12, 2013 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
May 2020 |
| Source |
I.M. Sechenov First Moscow State Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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). 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.
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.
