Skip to main content
Clinical Trials/NCT02459639
NCT02459639UnknownNot Applicable

Existential Genomics (ExiGence): Effects of Multimodal Rehabilitation and Integrative Care on Pain, Quality of Life, and Genomic Stability in Patients With Chronic Pain

The Integrative Care Science Center0 sites100 target enrollmentStarted: June 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Primary Endpoint
Telomere length from blood sample leucocyte cells

Study Overview

Brief Summary

Using a comprehensive prospective clinical study design, the investigators intend to compare changes in health-related markers in patients with chronic widespread pain (CWP), undergoing one of two intervention "packages" of multimodal health care, namely anthroposophical integrative care (AIC) or standard care (SC), respectively. AIC combines evidence-based conventional care with complementary/alternative (CAM) treatments. As markers, the investigators will use indicators of drug utilization and sick leave, as well as constructs mirroring possible changes in psychological and existential factors and genomic stability (such as telomere length and telomerase levels).

Detailed Description

The purpose of this comprehensive prospective clinical study is to compare and contrast two different but well-established multimodal chronic widespread pain rehabilitation programmes, i.e. one at a conventional county council hospital (CC) and one involving integrative care at a private non-profit hospital (IC), in terms of changes in health-related outcomes, ranging from DNA stability to health economy, in patients with chronic pain. Notably, for the first time, differences can be seen and correlations made between CC and IC outcomes with relevance for clinical care development and implementation of multimodal interventions for people with chronic pain.

The overall aim of the present prospective clinical trial is to achieve a better understanding of the possible effects of, and useful measure for evaluating, two different multimodal treatment interventions for pain.

More specifically, the aims of this trial are to explore two different, but well-established multimodal pain rehabilitation programmes. The investigators will specifically investigate 1. If chronic pain impacts on patients' telomerase activity and telomere length over time; 2. If multimodal rehabilitation can be linked to positive changes in telomerase activity and telomere length after rehabilitation, and if these changes can be correlated to: Clinical diagnosis, pain characteristics (e.g. intensity, duration, frequency and spread of pain), co-morbidities (e.g. anxiety, depression and catastrophizing), time lost from work/sick-leave and self-rated health and stress, and; 3. If and how the two programmes and their treatment components differ in outcomes over time.

The project outcomes will be of great relevance for clinical rehabilitation development and the implementation of multimodal interventions for people with chronic pain. Given that the most significant demographic and clinical factors associated with pain help-seeking are increasing age, female gender, pain severity and disability, we will also address such issues including gender differences when relevant.

Specific work packages (WP): WP1 - Genomics (telomerase activity and telomere length); WP2 - Patient-reported outcomes ("existential" validated questionnaires regarding depression, anxiety, stress, quality of life, pain, mindfulness, spirituality/religiosity); WP3 - Health care experiences (interviews); WP4 - Registry data (drugs, health care, sick leave, return-to-work, morbidity, mortality); WP5 - The design of treatment programs; WP6 - Standardized and exploratory statistical analyses of differences and correlations between the collected data and the conventional and integrated care programs. WP7 - Implementation of the results problematized through the participation of representatives of the patient and care provider organizations.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pain patients with a primary diagnosis corresponding to ICD-10 M79, or long-term pain for a period of over 3 months in neck/shoulders and/or low back, or generalised pain,
  • fluency in Swedish and
  • allowing for co-morbidity/ multiple secondary diagnoses.

Exclusion Criteria

  • Psychotic illness,
  • schizophrenia,
  • bipolar disorder,
  • substance dependency problems, and

Outcomes

Primary Outcomes

Telomere length from blood sample leucocyte cells

Time Frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up

telomere length from blood sample leucocyte cells

Telomerase activity from blood sample leucocyte cells

Time Frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up

telomerase activity from blood sample leucocyte cells

Secondary Outcomes

  • LDL-cholesterol levels in blood sample(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Blood pressure(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Cholesterol: Blood cholesterol levels(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • C-Reactive Protein levels in blood sample(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Trigyceride levels in blood sample(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Chronic Pain Acceptance Questionnaire - 8: measuring acceptance of chronic pain(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Hb - hemoglobin status(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • EuroQol 5 Dimensions: measuring health-related quality of life(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Indicator Questions of Physical Activity: measuring level of physical activity(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Sick-leave data(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Glucose levels in blood sample(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • HDL-cholesterol levels in blood sample(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Body Mass Index(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Hospital Anxiety and Depression scale: measuring level of anxiety and depression(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • WHO Quality of Life - Spiritual, Religious and Personal Beliefs(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Five Facet Mindfulness Questionnaire: measuring level of mindfulness(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • Use of prescription drugs(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)
  • patient records(up to 6 weeks and 1 year follow-up)
  • sociodemographic questionnaire(baseline, up to 6 weeks, 6 month-, and 1 year follow-up)

Investigators

Sponsor
The Integrative Care Science Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Torkel Falkenberg

Associate Professor

The Integrative Care Science Center

Similar Trials