NCT03028051

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
477

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Status
completed

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

September 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

January 2, 2017

Last Update Submit

January 24, 2017

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Change of quality of life as assessed by 15 Dimensions questionnaire between baseline and 2 years

    Baseline and 2 years

    2 years

Study Arms (1)

chronic pain patients

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult, Finnish-speaking patients, aged 18-75 years, referred to a pain clinic for multidisciplinary pain treatment.

You may qualify if:

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

You may not qualify if:

  • inability to fill in questionnaires in Finnish
  • cancer pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples frozen for possible further biochemical analysis (vitamin D, S-PTH, S-TSH, cytokines, P-Ca++)

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eija Kalso, Professor

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D., pain specialist

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 23, 2017

Study Start

September 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share