Clinical trial NCT02459639: Existential Genomics: Effects of Multimodal Rehabilitation and Integrative Care on Patients With Chronic Pain
Official title: Existential Genomics (ExiGence): Effects of Multimodal Rehabilitation and Integrative Care on Pain, Quality of Life, and Genomic Stability in Patients With Chronic Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: Chronic Widespread Pain
Telomere length
Multimodal rehabilitation
Integrative care
Existential aspects
Lead sponsor: The Integrative Care Science Center
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
name: Ekhagastiftelsen
First posted: 2015-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 pain patients will be recruited into the study. They will be invited to participate in the study upon admission to Integrative Care pain rehabilitation at the Vidar Clinic (n=50) or the Pain Clinic, University Hospital, Linköping (n=50).

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.

Eligibility criteria: 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
* cancer.

Primary outcomes:
measure: Telomere length from blood sample leucocyte cells
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Telomerase activity from blood sample leucocyte cells
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Secondary outcomes:
measure: Hb - hemoglobin status
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Cholesterol: Blood cholesterol levels
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: C-Reactive Protein levels in blood sample
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Trigyceride levels in blood sample
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Glucose levels in blood sample
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: LDL-cholesterol levels in blood sample
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: HDL-cholesterol levels in blood sample
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Blood pressure
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Body Mass Index
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Chronic Pain Acceptance Questionnaire - 8: measuring acceptance of chronic pain
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Five Facet Mindfulness Questionnaire: measuring level of mindfulness
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Hospital Anxiety and Depression scale: measuring level of anxiety and depression
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: EuroQol 5 Dimensions: measuring health-related quality of life
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Indicator Questions of Physical Activity: measuring level of physical activity
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: sociodemographic questionnaire
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: WHO Quality of Life - Spiritual, Religious and Personal Beliefs
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Use of prescription drugs
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: Sick-leave data
timeFrame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
measure: patient records
timeFrame: up to 6 weeks and 1 year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Integrative Care Science Center
name: Torkel Falkenberg, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References: