We hypothesize that patients with type 2 diabetes mellitus (T2DM) in the Netherlands have a lower prevalence of limited joint mobility compared to the literature (phase one). Diabetes patients with shoulder pain have shoulder muscle denervation, as…
ID
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Aandoening
Research has shown that diabetic patients have an increased risk for developing limited joint mobility (LJM). In this study LJM is used as an umbrella term for several musculoskeletal disorders such as adhesive capsulitis, carpal tunnel syndrome, dupuytren contracture and trigger finger. The exact pathophysiology of shoulder disorders in diabetes patients remains uncertain, but there is evidence that the shoulder can be affected through two pathophysiological pathways: connective tissue damage and neuropathy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The three primary outcomes of this study are the following:<br>
1. The prevalence of upper extremity LJM in patients with T2DM;<br>
2. The prevalence of specific shoulder disorders in T2DM patients with shoulder pain;<br>
3. The presence of muscle denervation, as a sign of diabetic neuropathy, in T2DM patients with shoulder pain.
Achtergrond van het onderzoek
Background:
Diabetes is common in the Netherlands, and also shoulder and hand disorders are frequently seen in Dutch general practice. Despite the fact that several international studies concluded that examination of the hand and shoulder should be included in diabetic patients’ periodic checks, screening for limited joint mobility (LJM) is not incorporated in the guidelines. Given the relationship between the duration of hyperglycaemia and LJM, the question arises whether LJM is also prevalent in the Dutch diabetes population. If LJM is prevalent, early diagnosis and treatment can reduce pain and functional limitations, allowing for a better control of normal daily activities, self-management and quality of life. Furthermore, the exact pathophysiology of shoulder disorders in diabetes patients remains uncertain, but there is evidence that the shoulder can be affected through two pathophysiological pathways: connective tissue damage and neuropathy. New, in-depth knowledge is needed in order to prevent the development of chronic shoulder pain.
Objectives:
Primary objectives:
1. Estimate the prevalence of upper extremity LJM in patients with T2DM;
2. Estimate the prevalence of specific shoulder disorders in T2DM patients with shoulder pain;
3. Investigate whether muscle denervation, as a sign of diabetic neuropathy, is present in T2DM patients with shoulder pain.
Secondary objective:
Investigate whether muscle denervation is associated with rotator cuff disorders and adhesive capsulitis in patients with and without T2DM.
Research questions:
Phase 1:
- What is the prevalence of upper limb LJM in T2DM patients in general practice?
Phase 2:
1- What is the prevalence of specific shoulder disorders in T2DMs patients with shoulder pain?
2-Do T2DM patients with shoulder pain have signs of muscle denervation suggesting neuropathy?
Study design:
Cross sectional study.
Population:
T2DM patients aged between 30 and 70 years will be recruited for phase 1 during their periodic check-up by diabetes nurses. Those patients from phase 1 who suffer from shoulder pain will be invited to participate in phase 2. Additionally, non-diabetes patients with shoulder pain referred to the Meditta Medical Center by GPs for ultrasound imaging (US) will be recruited to serve as control subjects.
Intervention:
Phase one: A patients questionnaire that enquires musculoskeletal pain of the upper extremity, including questions about complaints and disorders.
Phase two: The following diagnostic examinations will be carried out: a regular shoulder ultrasound, a physical examination of the shoulder, and a Qualitative Muscle Ultrasound of the shoulder for grayscale analysis.
Recruiting countries:
This study will be conducted in The Netherlands.
Doel van het onderzoek
We hypothesize that patients with type 2 diabetes mellitus (T2DM) in the Netherlands have a lower prevalence of limited joint mobility compared to the literature (phase one). Diabetes patients with shoulder pain have shoulder muscle denervation, as a sign of diabetes neuropathy (phase two).
Onderzoeksopzet
The measurements will be carried out from March 2018 to July 2018.
Onderzoeksproduct en/of interventie
Phase one: Nurse practitioners, employed by the diabetes care group Meditta in The Netherlands, approach T2DM patients during the regular diabetes check up to fill in a questionnaire. These nurses are trained in providing the information of the study. Interested patients will receive an envelope containing the following documents: patient information letter, informed consent , patient questionnaire, a separate invitation letter for phase 2 attached to the questionnaire, and a return envelope. Additionally, the diabetes nurse fills in a short case report form containing last reading of HbA1C, current BMI and year of diabetes diagnosis. The patients’ questionnaire will enquire about sex and age, and musculoskeletal pain of the upper extremity, including questions about complaints and disorders.
Phase two: Type 2 diabetes patients who indicate in phase 1 to suffer from shoulder pain and have interest in phase 2 will be invited for diagnostic examinations: a physical exam of the shoulder and a neurological exam of the feet, a regular shoulder ultrasound performed by a radiologist, and a Qualitative Muscle Ultrasound of the shoulder for grayscale analysis, which will be performed by a trained medical doctor of our research team.
Publiek
Ramon Ottenheijm
Maastricht 6200 MD
The Netherlands
+31 (0)43 3882338
ramon.ottenheijm@hag.unimaas.nl
Wetenschappelijk
Ramon Ottenheijm
Maastricht 6200 MD
The Netherlands
+31 (0)43 3882338
ramon.ottenheijm@hag.unimaas.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Phase 1: Patients with type 2 diabetes, men and women aged between 30 and 70 years.
Phase 2: Patients from phase one with shoulder pain for at least four weeks. For matched control subjects, non-diabetes patients with unilateral shoulder pain will be included.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients who meet any of the following criteria will be excluded from participation
1- Inability to complete a questionnaire independently
2- Unable to give informed consent.
Opzet
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Register | ID |
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