Existential Genomics: Effects of Multimodal Rehabilitation and Integrative Care on Patients With Chronic Pain
ExiGence
Existential Genomics (ExiGence): Effects of Multimodal Rehabilitation and Integrative Care on Pain, Quality of Life, and Genomic Stability in Patients With Chronic Pain
1 other identifier
observational
100
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJune 3, 2015
June 1, 2015
1.9 years
May 21, 2015
June 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (19)
Hb - hemoglobin status
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
Glucose levels in blood sample
baseline, up to 6 weeks, 6 month-, and 1 year follow-up
- +14 more secondary outcomes
Study Arms (2)
Anthroposophic integrative care
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
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.
Interventions
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.
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.
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- Psychotic illness,
- schizophrenia,
- bipolar disorder,
- substance dependency problems, and
- cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Integrative Care Science Centerlead
- University Hospital, Linkoepingcollaborator
- Ekhagastiftelsencollaborator
Related Publications (1)
Ronne-Petersen L, Niemi M, Walach H, Lavebratt C, Yang LL, Gerdle B, Ghafouri B, Falkenberg T. Exploring emotional well-being, spiritual, religious and personal beliefs and telomere length in chronic pain patients-A pilot study with cross-sectional design. PLoS One. 2024 Sep 4;19(9):e0308924. doi: 10.1371/journal.pone.0308924. eCollection 2024.
PMID: 39231146DERIVED
Biospecimen
Leucocyte cell extracts
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torkel Falkenberg, Ass. Prof
Integrative Care Science Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 21, 2015
First Posted
June 2, 2015
Study Start
June 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
June 3, 2015
Record last verified: 2015-06