NCT03338868

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

November 7, 2017

Last Update Submit

November 10, 2017

Conditions

Keywords

physical activitypainuric acid

Outcome Measures

Primary Outcomes (1)

  • Blood tests

    for uric acid levels.

    2 years

Secondary Outcomes (5)

  • Body composition

    2 years

  • Physical activity level

    2 years

  • The musculoskeletal pain intensity

    2 years

  • Quality of life

    2 years

  • Psychological Well-Being (Anxiety and Deppression condition)

    2 years

Study Arms (2)

Patients with MetS

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 compositionOther: Physical activity levelOther: Musculoskeletal pain intensityOther: Quality of lifeOther: Psychological Well-BeingDiagnostic Test: Blood tests

Patients without MetS

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 compositionOther: Physical activity levelOther: Musculoskeletal pain intensityOther: Quality of lifeOther: Psychological Well-BeingDiagnostic Test: Blood tests

Interventions

evaluated by Bodystat®1500 Bio-impedance Analyzer

Patients with MetSPatients without MetS

assessed by the International Physical Activity Questionnaire-7

Patients with MetSPatients without MetS

evaluated with Visual Analog Scale

Patients with MetSPatients without MetS

assessed by the Nottingham Health Profile

Patients with MetSPatients without MetS

assessed by the Hospital Anxiety and Depression Scale

Patients with MetSPatients without MetS
Blood testsDIAGNOSTIC_TEST

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.

Patients with MetSPatients without MetS

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients having chronic musculoskeletal pain with and without metabolic syndrome

You may qualify if:

  • 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.

You may not qualify if:

  • the presence of severe physical disability, psychiatric disorder, malignant tumors, pregnancy, chronic alcohol consumption, gout, heart failure, liver and renal dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ataturk Training and Research Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Ataturk Training and Research Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

RECRUITING

Related 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.

  • 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.

  • 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.

  • Saboya PP, Bodanese LC, Zimmermann PR, Gustavo AD, Assumpcao 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.

  • 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.

MeSH Terms

Conditions

Metabolic SyndromeMotor ActivityPain

Interventions

Body CompositionQuality of LifeMental HealthHematologic Tests

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biochemical PhenomenaChemical PhenomenaMetabolismBody ConstitutionPhysiological PhenomenaHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthHealthPopulation CharacteristicsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Seyda Toprak Celenay, Assist prof

    Ankara Yildirim Beyazit University Ataturk Training and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Seyda Toprak Celenay, Asist Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

August 1, 2015

Primary Completion

November 30, 2017

Study Completion

December 30, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations