Serum Concentrations, Physical and Psychological Well-being in Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the serum concentrations, physical and psychological well-being characteristics in patients having chronic musculoskeletal pain with metabolic syndrome, and to compare patients without metabolic syndrome.

Detailed Description
-----------------
Metabolic syndrome (MetS) is a combination of metabolic risk factors such as impaired glucose level, dyslipidemia, hypertension, and central obesity. MetS has become a large public health issue with common interrelation to different accompanying disorders. Moreover, the link between MetS and musculoskeletal disorders has previously been demonstrated. Presence and prevalence of MetS in patients having musculoskeletal pain seems common and interrelated.However, to our knowledge, manifestations with clinical symptoms of MetS, some inflammatory markers via serum concentrations and physical and psychological health profiles of patients with seeking treatment from outpatient physical therapy for musculoskeletal pain conditions have not been researched up to now.

Official Title
-----------------
Comparison of Serum Concentrations, Physical and Psychological Well-being in Patients Having Chronic Musculoskeletal Pain With and Without Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Body composition
* Other: Physical activity level
* Other: Musculoskeletal pain intensity
* Other: Quality of life
* Other: Psychological Well-Being
* Diagnostic Test: Blood tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months. Exclusion Criteria: the presence of severe physical disability, psychiatric disorder, malignant tumors, pregnancy, chronic alcohol consumption, gout, heart failure, liver and renal dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without MetS<br>To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months. | Other: Body composition<br>* evaluated by Bodystat®1500 Bio-impedance Analyzer<br>Other: Physical activity level<br>* assessed by the International Physical Activity Questionnaire-7<br>Other: Musculoskeletal pain intensity<br>* evaluated with Visual Analog Scale<br>Other: Quality of life<br>* assessed by the Nottingham Health Profile<br>Other: Psychological Well-Being<br>* assessed by the Hospital Anxiety and Depression Scale<br>Diagnostic Test: Blood tests<br>* Blood tests included serum glucose, triglyceride, high-density lipoprotein cholesterol (HDL-C), and uric acid levels. Blood samples were collected from the patients after one night of fasting.<br>|
| Patients with MetS<br>To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months. | Other: Body composition<br>* evaluated by Bodystat®1500 Bio-impedance Analyzer<br>Other: Physical activity level<br>* assessed by the International Physical Activity Questionnaire-7<br>Other: Musculoskeletal pain intensity<br>* evaluated with Visual Analog Scale<br>Other: Quality of life<br>* assessed by the Nottingham Health Profile<br>Other: Psychological Well-Being<br>* assessed by the Hospital Anxiety and Depression Scale<br>Diagnostic Test: Blood tests<br>* Blood tests included serum glucose, triglyceride, high-density lipoprotein cholesterol (HDL-C), and uric acid levels. Blood samples were collected from the patients after one night of fasting.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood tests | for uric acid levels. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | evaluated by Bodystat®1500 Bio-impedance Analyzer | 2 years | 
| Physical activity level | assessed by the International Physical Activity Questionnaire-7. The intensity of self-reported physical activity, lasting at ten minutes per bout, was used to assess metabolic equivalent (MET). The MET is defined as the ratio of a working metabolic rate to a standard resting metabolic rate.MET-minutes/week was computed by multiplying the MET score of an activity (3.3 for walking, 4.0 for moderate-intensity, and 8.0 for vigorous-intensity) by the minutes and days performed. The summation of walking, moderate, and vigorous METs-minutes/week enabled the computation of the total physical activity performed by an individual. | 2 years | 
| The musculoskeletal pain intensity | evaluated with 0 to 10 cm Visual Analog Scale. 0 indicated no pain and the 10 indicated the worst imaginable pain. | 2 years | 
| Quality of life | evaluated with the Nottingham Health Profile (NHP). It contains 38 items divided into 6 dimensions: NHP-energy, NHP-pain, NHP-emotional reactions, NHP sleep, NHP-social isolation, and NHP-physical mobility. All the parameters are summed as NHP-total. The respondent answers yes if the statement adequately reflected the current status or feeling, or no otherwise. Dimension scores ranged from 0 (no problems) to 100 (maximum problems). | 2 years | 
| Psychological Well-Being (Anxiety and Deppression condition) | evaluated with the Hospital Anxiety and Depression Scale (HADS). Each question was scored on a 4-point Likert scale, ranging from 0 to 3, where a higher score represented more severe anxiety or depression. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical activity, pain, uric acid