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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03338868
• Other study ID #: 2015-13/32
• Status: Recruiting
• Phase: N/A
• First received: November 7, 2017
• Last updated: November 10, 2017
• Start date: August 1, 2015
• Est. completion date: December 30, 2017

Study information

• Verified date: November 2017
• Source: Ataturk Training and Research Hospital
• Contact: Seyda Toprak Celenay, Asist Prof
• Phone: +90 530 041 3986
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Body composition
evaluated by Bodystat®1500 Bio-impedance Analyzer
• Physical activity level
assessed by the International Physical Activity Questionnaire-7
• Musculoskeletal pain intensity
evaluated with Visual Analog Scale
• Quality of life
assessed by the Nottingham Health Profile
• Psychological Well-Being
assessed by the Hospital Anxiety and Depression Scale

Diagnostic Test:
• Blood tests
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.

Locations

Country	Name	City	State
Turkey	Ataturk Training and Research Hospital	Ankara	Cankaya
Turkey	Ataturk Training and Research Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Afzal N, Mahmud TE, Jahan SS, Kundi S. Uric acid profile in patients with chronic nonspecific musculoskeletal pain. J Ayub Med Coll Abbottabad. 2003 Oct-Dec;15(4):5-9. — View Citation

Chu AH, Moy FM. Association between physical activity and metabolic syndrome among Malay adults in a developing country, Malaysia. J Sci Med Sport. 2014 Mar;17(2):195-200. doi: 10.1016/j.jsams.2013.04.003. Epub 2013 May 9. — View Citation

Fu YQ, Yang H, Zheng JS, Zeng XY, Zeng W, Fan ZF, Chen M, Wang L, Li D. Positive association between metabolic syndrome and serum uric acid in Wuhan. Asia Pac J Clin Nutr. 2017 Mar;26(2):343-350. doi: 10.6133/apjcn.012016.06. — View Citation

Saboya PP, Bodanese LC, Zimmermann PR, Gustavo AD, Assumpção CM, Londero F. Metabolic syndrome and quality of life: a systematic review. Rev Lat Am Enfermagem. 2016 Nov 28;24:e2848. doi: 10.1590/1518-8345.1573.2848. English, Portuguese, Spanish. — View Citation

Takeuchi T, Nakao M, Nomura K, Inoue M, Tsurugano S, Shinozaki Y, Yano E. Association of the metabolic syndrome with depression and anxiety in Japanese men: a 1-year cohort study. Diabetes Metab Res Rev. 2009 Nov;25(8):762-7. doi: 10.1002/dmrr.1041. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood tests	for uric acid levels.	2 years
Secondary	Body composition	evaluated by Bodystat®1500 Bio-impedance Analyzer	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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