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

• Conditions: Metabolic Syndrome
• Interventions: Other: Body composition; Other: Physical activity level; Other: Musculoskeletal pain intensity; Other: Quality of life; Other: Psychological Well-Being; Diagnostic Test: Blood tests

• Registration Number: NCT03338868
• Lead Sponsor: Ataturk Training and Research Hospital

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.

Study Timeline

• Study Start: 2015-08-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-09
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-17
• Primary Completion: 2017-11-30
• Study Completion: 2017-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without MetS	Body composition	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.
Patients without MetS	Quality of life	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.
Patients with MetS	Body composition	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.
Patients with MetS	Physical activity level	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.
Patients without MetS	Physical activity level	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.
Patients without MetS	Musculoskeletal pain intensity	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.
Patients with MetS	Musculoskeletal pain intensity	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.
Patients without MetS	Psychological Well-Being	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.
Patients without MetS	Blood tests	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.
Patients with MetS	Quality of life	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.
Patients with MetS	Psychological Well-Being	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.
Patients with MetS	Blood tests	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.

Primary Outcome Measures

Name	Time	Method
Blood tests	2 years	for uric acid levels.

Secondary Outcome Measures

Name	Time	Method
Body composition	2 years	evaluated by Bodystat®1500 Bio-impedance Analyzer
Physical activity level	2 years	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.
Quality of life	2 years	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).
Psychological Well-Being (Anxiety and Deppression condition)	2 years	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.
The musculoskeletal pain intensity	2 years	evaluated with 0 to 10 cm Visual Analog Scale. "0" indicated "no pain" and the "10" indicated "the worst imaginable pain".

Trial Locations

Locations (1)

Ataturk Training and Research Hospital; 🇹🇷 Ankara, Cankaya, Turkey