Chronic PainIMPERApainNCT01346202
Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes
An observational study of Chronic Pain, run by Klinikum St. Georg gGmbH at 1 site in Germany.
Trial summary
Complex and chronified pain syndromes requires a specialized therapeutic concept. From patients with chronic low back pain the investigators know, that an interdisciplinary multi-modal approach may improve the therapeutic success. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- How many people
- 260 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Jul 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 260 consecutive patients with chronic pain syndromes
Who may be able to join
- age >= 18 years and <= 65 years
- verified chronic pain for more than 6 month
Who cannot join
- application for a pension
- non-accordance with multi-modal pain therapy
- dominant geriatric symptoms
- dominant psychiatric symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Multimodal Day-unit Pain Therapy on Pain Experience, Pain-related Disability and Depression in Patients With Chronic Pain Syndromes
Complex and chronified pain syndromes requires a specialized therapeutic concept. From patients with chronic low back pain the investigators know, that an interdisciplinary multi-modal approach may improve the therapeutic success. In this observational study the investigators investigated if the multi-modal pain therapy is also effective in patients with mixed chronic pain syndromes.
Read the detailed description
The multi-modal pain therapy includes:
- specific drug therapy
- pain education
- psychological therapy
- physical therapy
- behavioral therapy
- work hardening
- bio-feedback
- ergotherapy
- Conditions
- Chronic Pain
- Keywords
- multi-modal pain therapy, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic pain | 260 consecutive patients with verified chronic pain syndromes |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity of pain
pain intensity 1 year after multi-modale therapy compared with pain intensity before treatment
Measured: Change from Baseline in intensity of pain at 1 year
Secondary outcomes (1)
pain disability index
pain disability index 6 month after multi-modale therapy compared with pain disability index before treatment
Measured: Change from Baseline in pain disability index at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionJul 2013
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
- Retrospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum St. Georg gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Sablotzki, MD, Klinikum St. Georg gGmbH
- Investigators
- Armin R Sablotzki, MD, PhD, Principal investigator, Klinikum St. Georg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346202
- Sponsor's protocol ID
- EK-BR-28/10-1
- Acronym
- IMPERApain
- Status last verified
- Jul 2013
- First submitted
- 27 Apr 2011
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Multimodal Day-unit Pain Therapy on Pain Experience, Pain-related Disability and Depression in Patients With Chronic Pain Syndromes
- ClinicalTrials.gov ID
- NCT01346202
- Acronym / sponsor ID
- IMPERApain / EK-BR-28/10-1
- Conditions
- Chronic Pain
- Keywords
- multi-modal pain therapy, chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Klinikum St. Georg gGmbHUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 May 2011 (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.
Complex and chronified pain syndromes requires a specialized therapeutic concept. From patients with chronic low back pain the investigators know, that an interdisciplinary multi-modal approach may improve the therapeutic success. In this observational study the investigators investigated if the multi-modal pain therapy is also effective in patients with mixed chronic pain syndromes.
Detailed description
The multi-modal pain therapy includes:
- specific drug therapy
- pain education
- psychological therapy
- physical therapy
- behavioral therapy
- work hardening
- bio-feedback
- ergotherapy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic pain | – | –260 consecutive patients with verified chronic pain syndromes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 260 consecutive patients with chronic pain syndromes
Key inclusion criteria (2 listed)
- age >= 18 years and <= 65 years
- verified chronic pain for more than 6 month
Key exclusion criteria (4 listed)
- application for a pension
- non-accordance with multi-modal pain therapy
- dominant geriatric symptoms
- dominant psychiatric symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intensity of pain
Time frame: Change from Baseline in intensity of pain at 1 year
pain intensity 1 year after multi-modale therapy compared with pain intensity before treatment
1 secondary outcome
pain disability index
Time frame: Change from Baseline in pain disability index at 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 15 Jul 2013.
- Related InfoLink provided by the sponsor.
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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.
Armin R Sablotzki, MD, PhD principal investigator
Klinikum St. Georg
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 Klinikum St. Georg gGmbH 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 2 inclusion and 4 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 15 Jul 2013. 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?
intensity of pain (time frame: Change from Baseline in intensity of pain at 1 year). 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 15 Jul 2013.