- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028051
Chronic Pain, Life Style Factors and Quality of Life
January 24, 2017 updated by: Tarja Heiskanen, Helsinki University Central Hospital
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
477
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult, Finnish-speaking patients, aged 18-75 years, referred to a pain clinic for multidisciplinary pain treatment.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
chronic pain patients
Finnish speaking, adult chronic pain patients, aged 18 - 75 years, referred to pain clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of quality of life as assessed by 15 Dimensions questionnaire between baseline and 2 years
Time Frame: 2 years
|
Baseline and 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eija Kalso, Professor, Helsinki University Central Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
January 2, 2017
First Submitted That Met QC Criteria
January 19, 2017
First Posted (Estimate)
January 23, 2017
Study Record Updates
Last Update Posted (Estimate)
January 25, 2017
Last Update Submitted That Met QC Criteria
January 24, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KROKIETA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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