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

Chronic Pain Clinical Trial

— ExiGence  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02459639
• Other study ID #: 2014-37
• Status: Not yet recruiting
• Phase: N/A
• First received: May 21, 2015
• Last updated: June 2, 2015
• Start date: June 2015
• Est. completion date: May 2017

Study information

• Verified date: June 2015
• Source: The Integrative Care Science Center
• Contact: Torkel Falkenberg, Ass. Prof.
• Phone: +46706183868
• Email: torkel.falkenberg[@]integrativecare.se
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Anthroposophic integrative care rehabilitation program
The programme for chronic pain at AIC consists of two phases: 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. 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.
• Conventional 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The Integrative Care Science Center	Ekhagastiftelsen, University Hospital, Linkoeping

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telomere length from blood sample leucocyte cells	telomere length from blood sample leucocyte cells	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Primary	Telomerase activity from blood sample leucocyte cells	telomerase activity from blood sample leucocyte cells	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Hb - hemoglobin status	blood hemoglobin status	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Cholesterol: Blood cholesterol levels	Blood cholesterol levels	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	C-Reactive Protein levels in blood sample	C-Reactive Protein	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Trigyceride levels in blood sample	Triglyceride levels in blood sample	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Glucose levels in blood sample	Glucose levels in blood sample	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	LDL-cholesterol levels in blood sample	LDL-cholesterol levels in blood sample	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	HDL-cholesterol levels in blood sample	HDL-cholesterol levels in blood sample	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Blood pressure	Resting systolic and diastolic blood pressure	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Body Mass Index	Body Mass Index calculated from weight and length	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Chronic Pain Acceptance Questionnaire - 8: measuring acceptance of chronic pain	8 question questionnaire assessing self-rated chronic pain acceptance, numerical total score	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Five Facet Mindfulness Questionnaire: measuring level of mindfulness	29 questionnaire assessing self-rated mindfulness, numerical composite score	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Hospital Anxiety and Depression scale: measuring level of anxiety and depression	self-rating scale for assessing anxiety and depression levels, numeric total score	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	EuroQol 5 Dimensions: measuring health-related quality of life	salf-rating scale for health-related quality of life, numeric total score	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Indicator Questions of Physical Activity: measuring level of physical activity	Self-rated assessment of physical activity, three questions, numeric total score	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	sociodemographic questionnaire	baseline and follow-up sociodemographic questionnaire from NRS (Nationalle Registret över Smärtrehabilitering), numeric descriptive data	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	WHO Quality of Life - Spiritual, Religious and Personal Beliefs	a medium- length 37 question version of a self-rating scale for quality of life, spiritual, religious and personal beliefs, numeric total score	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Use of prescription drugs	register-based data on use of prescription drugs, dose and frequency	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	Sick-leave data	register-based data on sick-leave, extent and time period	baseline, up to 6 weeks, 6 month-, and 1 year follow-up	No
Secondary	patient records	treatment records on the treatment components obtained by patient, amount and frequency	up to 6 weeks and 1 year follow-up	No