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

NCT ID: NCT02459639

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-05-31

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.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Anthroposophic integrative care rehabilitation program

Intervention Type: OTHER

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.

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.

Conventional multi-modal care rehabilitation

Intervention Type: OTHER

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.

Interventions

Anthroposophic 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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: collaborator

Ekhagastiftelsen

OTHER

Sponsor Role: collaborator

The Integrative Care Science Center

OTHER

Sponsor Role: lead

Responsible Party

Torkel Falkenberg

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torkel Falkenberg, Ass. Prof

Role: PRINCIPAL_INVESTIGATOR

Integrative Care Science Center

Central Contacts

Torkel Falkenberg, Ass. Prof.

Role: CONTACT

torkel.falkenberg@integrativecare.se

+46706183868

Maria Niemi, Ph. D.

Role: CONTACT

maria.niemi@ki.se

+46737887442

References

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.

Reference Type: DERIVED

PMID: 39231146 (View on PubMed)

Other Identifiers

2014-37

Identifier Type: -

Identifier Source: org_study_id