Existential Genomics: Effects of Multimodal Rehabilitation and Integrative Care on Patients With Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Other: Anthroposophic integrative care rehabilitation programOther: Conventional multi-modal care rehabilitation
- Registration Number
- NCT02459639
- Lead Sponsor
- The Integrative Care Science Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- Psychotic illness,
- schizophrenia,
- bipolar disorder,
- substance dependency problems, and
- cancer.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anthroposophic integrative care Anthroposophic integrative care rehabilitation program Inclusion criteria are: 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. The exclusion criteria are: psychotic illness, schizophrenia, bipolar disorder, substance dependency problems, and cancer. Multimodal pain rehabilitation Conventional multi-modal care rehabilitation Inclusion criteria are: 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. The exclusion criteria are: psychotic illness, schizophrenia, bipolar disorder, substance dependency problems, and cancer.
- Primary Outcome Measures
Name Time Method Telomere length from blood sample leucocyte cells 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 baseline, up to 6 weeks, 6 month-, and 1 year follow-up telomerase activity from blood sample leucocyte cells
- Secondary Outcome Measures
Name Time Method Hospital Anxiety and Depression scale: measuring level of anxiety and depression baseline, up to 6 weeks, 6 month-, and 1 year follow-up self-rating scale for assessing anxiety and depression levels, numeric total score
WHO Quality of Life - Spiritual, Religious and Personal Beliefs baseline, up to 6 weeks, 6 month-, and 1 year follow-up a medium- length 37 question version of a self-rating scale for quality of life, spiritual, religious and personal beliefs, numeric total score
LDL-cholesterol levels in blood sample baseline, up to 6 weeks, 6 month-, and 1 year follow-up LDL-cholesterol levels in blood sample
Blood pressure baseline, up to 6 weeks, 6 month-, and 1 year follow-up Resting systolic and diastolic blood pressure
Cholesterol: Blood cholesterol levels baseline, up to 6 weeks, 6 month-, and 1 year follow-up Blood cholesterol levels
C-Reactive Protein levels in blood sample baseline, up to 6 weeks, 6 month-, and 1 year follow-up C-Reactive Protein
Trigyceride levels in blood sample baseline, up to 6 weeks, 6 month-, and 1 year follow-up Triglyceride levels in blood sample
Body Mass Index baseline, up to 6 weeks, 6 month-, and 1 year follow-up Body Mass Index calculated from weight and length
Chronic Pain Acceptance Questionnaire - 8: measuring acceptance of chronic pain baseline, up to 6 weeks, 6 month-, and 1 year follow-up 8 question questionnaire assessing self-rated chronic pain acceptance, numerical total score
Hb - hemoglobin status baseline, up to 6 weeks, 6 month-, and 1 year follow-up blood hemoglobin status
EuroQol 5 Dimensions: measuring health-related quality of life baseline, up to 6 weeks, 6 month-, and 1 year follow-up salf-rating scale for health-related quality of life, numeric total score
Indicator Questions of Physical Activity: measuring level of physical activity baseline, up to 6 weeks, 6 month-, and 1 year follow-up Self-rated assessment of physical activity, three questions, numeric total score
Sick-leave data baseline, up to 6 weeks, 6 month-, and 1 year follow-up register-based data on sick-leave, extent and time period
Glucose levels in blood sample baseline, up to 6 weeks, 6 month-, and 1 year follow-up Glucose levels in blood sample
HDL-cholesterol levels in blood sample baseline, up to 6 weeks, 6 month-, and 1 year follow-up HDL-cholesterol levels in blood sample
Five Facet Mindfulness Questionnaire: measuring level of mindfulness baseline, up to 6 weeks, 6 month-, and 1 year follow-up 29 questionnaire assessing self-rated mindfulness, numerical composite score
Use of prescription drugs baseline, up to 6 weeks, 6 month-, and 1 year follow-up register-based data on use of prescription drugs, dose and frequency
patient records up to 6 weeks and 1 year follow-up treatment records on the treatment components obtained by patient, amount and frequency
sociodemographic questionnaire baseline, up to 6 weeks, 6 month-, and 1 year follow-up baseline and follow-up sociodemographic questionnaire from NRS (Nationalle Registret över Smärtrehabilitering), numeric descriptive data