Chronic PainPOSITAGNCT01805947
Lifestyle Modification Program for Patients With Chronic Pain Conditions
An observational study of Chronic Pain, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
In this observational study the effects of a Lifestyle Modification Program - offered as a semi-residential day care clinic - on pain, disability, quality of life and satisfaction with life will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Lifestyle Modification
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 patients with pain condition admitted to the lifestyle modification program
Who may be able to join
- 18-78
- diagnosed with any chronic pain condition
- physical and mental ability to participate in the program and the study
- written informed consent
Who cannot join
- participation in any other clinical study focusing on psychological or behavioral intervention
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, 45276
About this study
Official title: Process-outcome-study in the Context of a Lifestyle Modification Program for Patients With Chronic Pain Conditions
In this observational study the effects of a Lifestyle Modification Program - offered as a semi-residential day care clinic - on pain, disability, quality of life and satisfaction with life will be investigated. Furthermore the influence of mindfulness, acceptance and coping, and acquired changes in lifestyle behaviors on the outcome after the program will be evaluated.
Effects will be measured after completion of the program (3 months), and at 6 and 12 months follow up after start of the program, i.e. each outcome measure will be taken 4 times within 12 months.
Read the detailed description
see above
- Conditions
- Chronic Pain
- Being tested
- Lifestyle Modification
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ModificationBehavioural
Also called see Paul, A. et al.,Eur J Integr Med 2012, 4(4):e455-e459.
Lifestyle Modification
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification | All patients with chronic pain conditions participate in a 8-weeks structured group program. Detailed information on the mindfulness based program can be found in the publication by Paul, A. et al. "An Integrative Day Care Clinic for chronically ill patients: Concept and case presentation" in the European Journal of Integrative Medicine, 2012, 4(4):e455-e459. Receives: Behavioral: Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
Measured: 3 months
Pain intensity
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
Measured: 6 months
Pain intensity
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
Measured: 12 months
Secondary outcomes (14)
Disability
pain related disability in the domains everyday activity, leisure and work time, visual analogue scales
Measured: 3 months
Disability (PDI)
Pain Disability Index (Dillmann et al., 1994) validated questionnaire
Measured: 3 months
Quality of life (SF-36)
Short Form (36) Health Survey (SF-36) [Bullinger \& Kirchberger, 1998].
Measured: 3 months
Depression (BDI)
Beck Depression Inventory (BDI) [Beck, 1987; Hautzinger, 1992]
Measured: 3 months
Life satisfaction (BMLSS)
Brief Multidimensional Life Satisfaction Scale (BMLSS) [Büssing \& Fischer, 2009]
Measured: 3 months
Acceptance (ERDA)
Emotional/Rational Disease Acceptance Questionnaire [Büssing et al., 2008, 2010]
Measured: 3 months
Self efficacy
Questionnaire for pain specific self efficacy (FESS) [Mangels et al., 2009)
Measured: 3 months
Coping (AKU)
Questionnaire for adaptive coping (AKU) [Büssing \& Fischer, 2009]
Measured: 3 months
Mindfulness (CPSC)
modified Freiburger Mindfulness Inventory (Büssing et al.)
Measured: 3 months
Perceived Stress (PSS-10)
Perceived Stress Scale (PSS-10) [Büssing, 2011)
Measured: 3 months
Inner Congruence (ICPH)
Inner Congruence with the exercise practise of meditation/relaxation/yoga ... (Büssing et al., 2011)
Measured: 3 months
Practice Diary
Patients fill in a week long diary. Measured are the frequency of health behaviors
Measured: 3 months
Experiences with the program
- satisfaction with the program and perceived benefit
Measured: 3 months
Safety of the program
- safety
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witten/Herdecke
- Responsible party
- Principal investigator, Romy Lauche, Universität Duisburg-Essen
- Investigators
- Gustav J Dobos, Prof, MD, Study director, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of MedicineRomy Lauche, PhD, Principal investigator, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of MedicineHolger Cramer, PhD, Principal investigator, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805947
- Sponsor's protocol ID
- 12-5216 POSITAG
- Acronym
- POSITAG
- Status last verified
- Sep 2015
- First submitted
- 5 Mar 2013
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process-outcome-study in the Context of a Lifestyle Modification Program for Patients With Chronic Pain Conditions
- ClinicalTrials.gov ID
- NCT01805947
- Acronym / sponsor ID
- POSITAG / 12-5216 POSITAG
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- University of Witten/Herdecke
- Study start
- Jan 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this observational study the effects of a Lifestyle Modification Program - offered as a semi-residential day care clinic - on pain, disability, quality of life and satisfaction with life will be investigated. Furthermore the influence of mindfulness, acceptance and coping, and acquired changes in lifestyle behaviors on the outcome after the program will be evaluated.
Effects will be measured after completion of the program (3 months), and at 6 and 12 months follow up after start of the program, i.e. each outcome measure will be taken 4 times within 12 months.
Detailed description
see above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification | – | Behavioral: Lifestyle ModificationAll patients with chronic pain conditions participate in a 8-weeks structured group program. Detailed information on the mindfulness based program can be found in the publication by Paul, A. et al. "An Integrative Day Care Clinic for chronically ill patients: Concept and case presentation" in the European Journal of Integrative Medicine, 2012, 4(4):e455-e459. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients with pain condition admitted to the lifestyle modification program
Key inclusion criteria (4 listed)
- 18-78
- diagnosed with any chronic pain condition
- physical and mental ability to participate in the program and the study
- written informed consent
Key exclusion criteria (1 listed)
- participation in any other clinical study focusing on psychological or behavioral intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ModificationAlso: see Paul, A. et al.,Eur J Integr Med 2012, 4(4):e455-e459.Lifestyle Modification | Behavioural | Lifestyle Modification |
Primary outcome
Pain intensity
Time frame: 3 months
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
Pain intensity
Time frame: 6 months
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
Pain intensity
Time frame: 12 months
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
14 secondary outcomes
Disability
Time frame: 3 months
Disability (PDI)
Time frame: 3 months
Quality of life (SF-36)
Time frame: 3 months
Depression (BDI)
Time frame: 3 months
Life satisfaction (BMLSS)
Time frame: 3 months
Acceptance (ERDA)
Time frame: 3 months
Self efficacy
Time frame: 3 months
Coping (AKU)
Time frame: 3 months
Mindfulness (CPSC)
Time frame: 3 months
Perceived Stress (PSS-10)
Time frame: 3 months
Inner Congruence (ICPH)
Time frame: 3 months
Practice Diary
Time frame: 3 months
Experiences with the program
Time frame: 3 months
Safety of the program
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav J Dobos, Prof, MD study director
University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
Romy Lauche, PhD principal investigator
University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
Holger Cramer, PhD principal investigator
University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.