Chronic Pain, Life Style Factors and Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03028051
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
Tarja Heiskanen, Helsinki University Central Hospital

Brief Summary:
Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that aims to analyze life style factors, socioeconomic and psychometric properties, metabolic problems, drug use, quality of life and biochemical variables in chronic non-cancer pain patients. The life style factors will be compared to those of normal population. At baseline, the study patients fill in questionnaires (A-E), the patients´ weight, length, waist and blood pressure are measured, pain-related factors are recorded and blood samples taken. Changes in the quality of life of the study patients will be evaluated by questionnaires during follow-up at 2 years and 5 years.

Condition or disease
Chronic Pain

Detailed Description:
Chronic pain co-occurs with risk factors for cardiovascular diseases, depression, smoking and sleep problems. Nutrition and low physical activity may predispose to chronic pain. To gain information on the life style factors of adult chronic pain patients referred to university hospital or central hospital pain clinics in Finland, 477 patients have been recruited to the study. The patients fill in questionnaires on sociodemographic factors, pain, medication, use of health services, physical activity, smoking, use of alcohol or other substances, sleep, quality of life, nutrition and psychological factors at their first visit to the pain clinic. Height, weight, waist circumference, blood pressure and pulse are measured by the study nurse. A blood sample for analysis of blood sugar, cholesterol (total, LDL, HDL), triglycerides, HbA1c and sensitive C-reactive protein (CRP) is taken. The pain clinician records the pain diagnosis, medication and other methods of pain management chosen. The patients will be sent follow-up questionnaires at 2 years and 5 years after baseline.

Study Type : Observational
Actual Enrollment : 477 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Pain, Life Style Factors and Quality of Life
Study Start Date : September 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

chronic pain patients
Finnish speaking, adult chronic pain patients, aged 18 - 75 years, referred to pain clinic

Primary Outcome Measures :
  1. Change of quality of life as assessed by 15 Dimensions questionnaire between baseline and 2 years [ Time Frame: 2 years ]
    Baseline and 2 years

Biospecimen Retention:   Samples Without DNA
Blood samples frozen for possible further biochemical analysis (vitamin D, S-PTH, S-TSH, cytokines, P-Ca++)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult, Finnish-speaking patients, aged 18-75 years, referred to a pain clinic for multidisciplinary pain treatment.

Inclusion Criteria:

  • age 18 to 75 years
  • chronic non-cancer pain
  • Finnish-speaking
  • referred to a multidisciplinary pain management center

Exclusion Criteria:

  • inability to fill in questionnaires in Finnish
  • cancer pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03028051

Sponsors and Collaborators
Helsinki University Central Hospital
Principal Investigator: Eija Kalso, Professor Helsinki University Central Hospital

Responsible Party: Tarja Heiskanen, MD, Ph.D., pain specialist, Helsinki University Central Hospital Identifier: NCT03028051     History of Changes
Other Study ID Numbers: KROKIETA
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms