Chronic PainPOSITIVENCT02038244
Integrative Medicine for Chronic Pain
A study testing Multimodal integrative medicine inpatient treatment program in people with Chronic Pain, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for integrative medicine on pain, disability, quality of life, satisfaction with life, depression, and anxiety will be investigated. Furthermore the influence of potential process variables will be evaluated. 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?
- Multimodal integrative medicine inpatient treatment program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Mar 2015
- Phase
- Interventional
- 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
Who may be able to join
- diagnosed with any chronic pain condition
- at least 6 months pain duration
- written informed consent
Who cannot join
- participation in any other clinical study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen
About this study
Official title: Integrative Medicine for Chronic Pain - Process-Outcome-Study in the Context of an Internal Medicine Ward for Integrative Medicine
In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for integrative medicine on pain, disability, quality of life, satisfaction with life, depression, and anxiety will be investigated. Furthermore the influence of potential process variables will be evaluated.
Effects will be measured after completion of the program (2 weeks), and at 6 months follow up after start of the program.
- Conditions
- Chronic Pain
- Being tested
- Multimodal integrative medicine inpatient treatment program
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal integrative medicine inpatient treatment programOther
| Study group | Role | What they receive |
|---|---|---|
| Integrative Medicine | Experimental | Not described Receives: Other: Multimodal integrative medicine inpatient treatment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
VAS
Measured: 14 days
Secondary outcomes (12)
Pain Intensity
VAS
Measured: 6 months
Pain Disability
- German Pain Questionnaire
Measured: 14 days, 6 months
Health-related quality of life
Short Form (36) Health Survey
Measured: 14 days, 6 months
Life satisfaction
Brief Multidimensional Life Satisfaction Scale
Measured: 14 days, 6 months
Depression
Beck Depression Inventory
Measured: 14 days, 6 months
Acceptance
Emotional/Rational Disease Acceptance Questionnaire
Measured: 14 days, 6 months
Mindfulness
Conscious Presence and Self Control (CPSC) Scale
Measured: 14 days, 6 months
Subjective stress
Perceived Stress Scale
Measured: 14 days, 6 months
Easiness of life
Questionnaire on emotional and physical reactions
Measured: 14 days, 6 months
Ability and will to change
Ability and will to change Questionnaire
Measured: 14 days, 6 months
Safety
Adverse events
Measured: 14 days, 6 months
Pain Disability
- Pain Disability Index
Measured: 14 days, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionMar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 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, Holger Cramer, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038244
- Sponsor's protocol ID
- 135393-BO
- Acronym
- POSITIVE
- Status last verified
- May 2015
- First submitted
- 9 Jan 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Medicine for Chronic Pain - Process-Outcome-Study in the Context of an Internal Medicine Ward for Integrative Medicine
- ClinicalTrials.gov ID
- NCT02038244
- Acronym / sponsor ID
- POSITIVE / 135393-BO
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- University of Witten/Herdecke
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Jan 2014 (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 study, the effects of a 14-day inpatient treatment in an internal medicine ward for integrative medicine on pain, disability, quality of life, satisfaction with life, depression, and anxiety will be investigated. Furthermore the influence of potential process variables will be evaluated.
Effects will be measured after completion of the program (2 weeks), and at 6 months follow up after start of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative Medicine | Experimental | Other: Multimodal integrative medicine inpatient treatment program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with any chronic pain condition
- at least 6 months pain duration
- written informed consent
Key exclusion criteria (1 listed)
- participation in any other clinical study
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 |
|---|---|---|
| Multimodal integrative medicine inpatient treatment program | Other | Integrative Medicine |
Primary outcome
Pain Intensity
Time frame: 14 days
VAS
12 secondary outcomes
Pain Intensity
Time frame: 6 months
Pain Disability
Time frame: 14 days, 6 months
Health-related quality of life
Time frame: 14 days, 6 months
Life satisfaction
Time frame: 14 days, 6 months
Depression
Time frame: 14 days, 6 months
Acceptance
Time frame: 14 days, 6 months
Mindfulness
Time frame: 14 days, 6 months
Subjective stress
Time frame: 14 days, 6 months
Easiness of life
Time frame: 14 days, 6 months
Ability and will to change
Time frame: 14 days, 6 months
Safety
Time frame: 14 days, 6 months
Pain Disability
Time frame: 14 days, 6 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 23 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal integrative medicine inpatient treatment program in people with 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 3 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 23 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: 14 days). 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 23 Sep 2015.