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Existential Genomics: Effects of Multimodal Rehabilitation and Integrative Care on Patients With Chronic Pain

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02459639
Acronym
ExiGence
Enrollment
100
Registered
2015-06-02
Start date
2015-06-30
Completion date
2017-05-31
Last updated
2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic Widespread Pain, Telomere length, Multimodal rehabilitation, Integrative care, Existential aspects

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.

Interventions

OTHERAnthroposophic integrative care rehabilitation program

The programme for chronic pain at AIC consists of two phases: 1. A three-week in-patient period. During the first three-week in-patient stay, patients meet regularly with a multi-professional team. Usually, each patient receives two of the following therapies 2-4 times per week: art therapy, massage, physiotherapy, eurhythmy and baths. Nursing care is provided twice daily. Moreover, patients are offered to participate in group activities. 2. Two-three day inpatient follow-up and treatment period closure. The second phase of the treatment programme consists of a 2-3 day inpatient stay, 6 months after closure. During this time, physician, nurse and therapist appointments are made according to individual needs. The patients who have been engaged in group activities are gathered in groups.

OTHERConventional multi-modal care rehabilitation

The standard approach at Linköping University Hospital admits patients for bio-psycho-social assessment, pharmacological treatment and multimodal rehabilitation (main components: education, intense physical exercise, cognitive behavioural therapy and workplace interventions) for a 6 week intensive phase period (75%) followed by 4 weeks (25%). Here a number of professional disciplines collaborate and form a team of professionals focused on individual patient needs The multimodal rehabilitation outpatient program delivered by this team has the following aims: 1) reduce pain and psychological burden, 2) improve work capacity and decrease sick-leave and 3) increase perceived health and quality of life. These general aims are combined with the aims of the patient in a plan of rehabilitation.

Sponsors

University Hospital, Linkoeping
CollaboratorOTHER
Ekhagastiftelsen
CollaboratorOTHER
The Integrative Care Science Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 * cancer.

Design outcomes

Primary

MeasureTime frameDescription
Telomere length from blood sample leucocyte cellsbaseline, up to 6 weeks, 6 month-, and 1 year follow-uptelomere length from blood sample leucocyte cells
Telomerase activity from blood sample leucocyte cellsbaseline, up to 6 weeks, 6 month-, and 1 year follow-uptelomerase activity from blood sample leucocyte cells

Secondary

MeasureTime frameDescription
C-Reactive Protein levels in blood samplebaseline, up to 6 weeks, 6 month-, and 1 year follow-upC-Reactive Protein
Trigyceride levels in blood samplebaseline, up to 6 weeks, 6 month-, and 1 year follow-upTriglyceride levels in blood sample
Glucose levels in blood samplebaseline, up to 6 weeks, 6 month-, and 1 year follow-upGlucose levels in blood sample
LDL-cholesterol levels in blood samplebaseline, up to 6 weeks, 6 month-, and 1 year follow-upLDL-cholesterol levels in blood sample
HDL-cholesterol levels in blood samplebaseline, up to 6 weeks, 6 month-, and 1 year follow-upHDL-cholesterol levels in blood sample
Blood pressurebaseline, up to 6 weeks, 6 month-, and 1 year follow-upResting systolic and diastolic blood pressure
Body Mass Indexbaseline, up to 6 weeks, 6 month-, and 1 year follow-upBody Mass Index calculated from weight and length
Chronic Pain Acceptance Questionnaire - 8: measuring acceptance of chronic painbaseline, up to 6 weeks, 6 month-, and 1 year follow-up8 question questionnaire assessing self-rated chronic pain acceptance, numerical total score
Hb - hemoglobin statusbaseline, up to 6 weeks, 6 month-, and 1 year follow-upblood hemoglobin status
Hospital Anxiety and Depression scale: measuring level of anxiety and depressionbaseline, up to 6 weeks, 6 month-, and 1 year follow-upself-rating scale for assessing anxiety and depression levels, numeric total score
EuroQol 5 Dimensions: measuring health-related quality of lifebaseline, up to 6 weeks, 6 month-, and 1 year follow-upsalf-rating scale for health-related quality of life, numeric total score
Indicator Questions of Physical Activity: measuring level of physical activitybaseline, up to 6 weeks, 6 month-, and 1 year follow-upSelf-rated assessment of physical activity, three questions, numeric total score
sociodemographic questionnairebaseline, up to 6 weeks, 6 month-, and 1 year follow-upbaseline and follow-up sociodemographic questionnaire from NRS (Nationalle Registret över Smärtrehabilitering), numeric descriptive data
WHO Quality of Life - Spiritual, Religious and Personal Beliefsbaseline, up to 6 weeks, 6 month-, and 1 year follow-upa medium- length 37 question version of a self-rating scale for quality of life, spiritual, religious and personal beliefs, numeric total score
Use of prescription drugsbaseline, up to 6 weeks, 6 month-, and 1 year follow-upregister-based data on use of prescription drugs, dose and frequency
Sick-leave databaseline, up to 6 weeks, 6 month-, and 1 year follow-upregister-based data on sick-leave, extent and time period
patient recordsup to 6 weeks and 1 year follow-uptreatment records on the treatment components obtained by patient, amount and frequency
Five Facet Mindfulness Questionnaire: measuring level of mindfulnessbaseline, up to 6 weeks, 6 month-, and 1 year follow-up29 questionnaire assessing self-rated mindfulness, numerical composite score
Cholesterol: Blood cholesterol levelsbaseline, up to 6 weeks, 6 month-, and 1 year follow-upBlood cholesterol levels

Contacts

Primary ContactTorkel Falkenberg, Ass. Prof.
torkel.falkenberg@integrativecare.se+46706183868
Backup ContactMaria Niemi, Ph. D.
maria.niemi@ki.se+46737887442

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026