Low Back PainPhase 2/3RÜCKGEWINNNCT01070849
A Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare
A Phase 2/3 study testing educational booklet, IRENA and RÜCKGEWINN in people with Low Back Pain, run by University of Erlangen-Nürnberg at 6 sites in Germany.
Trial summary
Background: In chronic back pain, rehabilitation specific aftercare programs, needed for a long-term improvement of pain and functional ability, are absent. Purposeful and differentiated aftercare treatments offer the possibility, in particular in the rehabilitation of chronic back pain, to increase the sustainability… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- educational booklet, IRENA and RÜCKGEWINN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 6 sitesGermany
- Study dates
- Nov 2009to Oct 2011
- Phase
- Phase 2/3
- 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
Who may be able to join
- ICD-10 is used:
- M51.2 - M51.4
- M51.8 - M51.9
- M53.8 - M53.9
- M54.5, M54.8 - M54.9
- M54.4 (if radicular symptoms are not dominating)
Who cannot join
- specific reason for back pain, based on a clear cause or diagnosis, which could sufficiently explain its extent (e.g. radicular symptomatic, myelopathesis, inflammatory changes in the spinal column etc.)
- already carried out operation on the spine within the last year
- additional serious psychic diagnosis
- uncorrected serious visual and acoustic disability
- seriously reduced health status (other diseases) with considerable reduction of dexterity
- application for retirement
Show all 9Show fewer
- low German language skills (to fulfill the questionnaires)
- age lower than 18 or over 65
- residential area out of Berlin
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Rehabilitationsklinik Dübener Heide
Bad Schmiedeberg, Brandenburg, 6905
Rehabilitationsklinik Lautergrund
Bad Staffelstein, Bavaria, 96231
Zentrum für ambulante Rehabilitation (ZaR) Abt. I BO
Berlin, State of Berlin, 10115
Vivantes Rehabilitation Abt. I BO
Berlin, State of Berlin, 12157
REHA-Tagesklinik im Forum Pankow
Berlin, State of Berlin, 13187
MEDIAN Klinik Hoppegarten
Hoppegarten (Mark), Brandenburg, 15366
About this study
Official title: Effect and Sustainability of a Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare - a Randomised Controlled Trial
Background:
In chronic back pain, rehabilitation specific aftercare programs, needed for a long-term improvement of pain and functional ability, are absent. Purposeful and differentiated aftercare treatments offer the possibility, in particular in the rehabilitation of chronic back pain, to increase the sustainability of positive effects of a mostly three weeks taking rehabilitation or to intensify them.
Read more
Hypothesis:
The implementation of a developed bio-psycho-social aftercare intervention program for CLBP (RÜCKGEWINN) leeds to a better rehabilitation outcome in comparison to current usual aftercare (IRENA) and a control group in view of pain-conditioned functional ability and back pain episodes.
Methods/Design:
A multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation and twelve month after dismissal form rehabilitation into the aftercare program.
Read the detailed description
Background:
There is strong internationally confirmed evidence for short-term effectiveness of multimodal interdisciplinary specific treatment programmes for chronic back pain. Indeed, the proof of a lasting protection of achieved effects is missing so far. For a long-term improvement of pain and functional ability high intervention intensity or high extent seems to be necessary (> 100 therapy hours). Especially in chronic back pain rehabilitation specific aftercare programs are absent. Purposeful and differentiated aftercare treatments offer the possibility, in particular in the rehabilitation of chronic back pain, to increase the sustainability of positive effects of a mostly three weeks taking rehabilitation or to intensify them.
Hypothesis:
The implementation of a bio-psycho-social exercise based aftercare intervention program, specifically structured for the needs of chronic low back pain (CLBP) patients, leeds to a better rehabilitation outcome in comparison to current usual aftercare (IRENA) and a control group that is given an educational booklet in view of pain-conditioned functional ability and back pain episodes.
Methods/Design:
A multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation and twelve month after dismissal form rehabilitation into the aftercare program.
Discussion:
Special methodological and logistic challenges are to be mastered in this trial, which accrue from the engagement of aftercare interventions to their residential district and the fact the fact that the proportion of patients, who take part in aftercare programs, is low. The usability of the aftercare program lies in the transference into the routine care and is also given by developed manuals with structured contents, media and material for organisation assistance as well as training draughts for practise therapists in the aftercare.
- Conditions
- Low Back Pain
- Being tested
- educational booklet, IRENA, RÜCKGEWINN
- Keywords
- exercise, physical activity
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational bookletOther
Participants will receive an educational booklet and the advice to return to normal activities as soon as possible from their rehabilitation practitioner in their dismissal examination. As educational booklet the German version of the "back book" of Burton et al. was chosen. This booklet provides information about the new approach to back pain, causes of back pain, dealing with an attack of back pain, risk factors for development of chronic back pain and the role of activity. All information that is provided is in accordance with actual scientific knowledge and is based on a bio-psycho-social model of back pain like described in Waddell.
IRENAOther
Participants will be introduced into the normal IRENA program (in German: Intensivierte Rehabilitationsnachsorge), which is usual care in Germany. Every patient will be assigned to a certified aftercare facility near their residential area. Aftercare practitioners and patients can compile an individual therapeutic package from certain appointed therapeutic services. Predominantly resistance training, gymnastics, aquatic exercise, back school and recreation exercises are prescribed by the physicians for aftercare. Most therapies are carried out in open access groups of at least 6 patients without being specific for medical indication. In the IRENA program it is possible to pass the intended 24 exercise sessions with different frequency per week. Usually participants do two or three exercise sessions per week with duration of 90 to 120 minutes per session. Every aftercare facility offers certain therapy combinations at different days in week.
RÜCKGEWINNOther
For long term sustainability and the enhancement of intensity of the rehabilitation process this investigational aftercare intervention shows formal and didactic divergences from standard programmes in rehabilitation aftercare. Three important areas for multidimensional interventions are targeted: attitude and behaviour change concerning back pain, guidance to health enhancing physical activity, improvement of health related physical fitness. Every 90 minutes taking exercise session contains parts for mediation of knowledge, for behavioural modulation and for physical exercises and interlocks them in the mediation process. To take the time into account that is necessary for the process of behavioural change RÜCKGEWINN is planned for duration of six months in one session weekly for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| a) educational booklet | Active comparator | Not described Receives: Other: educational booklet |
| b) IRENA | Active comparator | Not described Receives: Other: IRENA |
| c) RÜCKGEWINN | Experimental | Not described Receives: Other: RÜCKGEWINN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.)
Measured: one year
Secondary outcomes (4)
Graded chronic pain (GCPS, Von Korff et al. 1992)
Measured: one year
Catastrophizing (KPI-AE KRSS, Hasenbring 1994)
Measured: one year
Fear avoidance Beliefs (TSK-DE, Schaub et al. 2004)
Measured: one year
Physical activity (Freiburger FB, Frey et al. 1999)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Rentenversicherung
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
- Investigators
- Klaus Pfeifer, Prof. Dr., Principal investigator, Institute of Sport Science and Sport / University of Erlangen-NürnbergChristian Hentschke, Dipl. Sportwiss., Study director, Institute of Sport Science and Sport / University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070849
- Sponsor's protocol ID
- 8011 - 106 - 31/31.87
- Acronym
- RÜCKGEWINN
- Status last verified
- Aug 2012
- First submitted
- 17 Feb 2010
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hentschke C, Hofmann J, Pfeifer K. A bio-psycho-social exercise program (RUCKGEWINN) for chronic low back pain in rehabilitation aftercare--study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2010 Nov 17;11:266. doi: 10.1186/1471-2474-11-266.
PubMed 21083918
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Sustainability of a Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01070849
- Acronym / sponsor ID
- RÜCKGEWINN / 8011 - 106 - 31/31.87
- Conditions
- Low Back Pain
- Keywords
- exercise, physical activity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- Deutsche Rentenversicherung
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Feb 2010 (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.
Background:
In chronic back pain, rehabilitation specific aftercare programs, needed for a long-term improvement of pain and functional ability, are absent. Purposeful and differentiated aftercare treatments offer the possibility, in particular in the rehabilitation of chronic back pain, to increase the sustainability of positive effects of a mostly three weeks taking rehabilitation or to intensify them.
Hypothesis:
The implementation of a developed bio-psycho-social aftercare intervention program for CLBP (RÜCKGEWINN) leeds to a better rehabilitation outcome in comparison to current usual aftercare (IRENA) and a control group in view of pain-conditioned functional ability and back pain episodes.
Methods/Design:
A multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation and twelve month after dismissal form rehabilitation into the aftercare program.
Detailed description
Background:
There is strong internationally confirmed evidence for short-term effectiveness of multimodal interdisciplinary specific treatment programmes for chronic back pain. Indeed, the proof of a lasting protection of achieved effects is missing so far. For a long-term improvement of pain and functional ability high intervention intensity or high extent seems to be necessary (> 100 therapy hours). Especially in chronic back pain rehabilitation specific aftercare programs are absent. Purposeful and differentiated aftercare treatments offer the possibility, in particular in the rehabilitation of chronic back pain, to increase the sustainability of positive effects of a mostly three weeks taking rehabilitation or to intensify them.
Hypothesis:
The implementation of a bio-psycho-social exercise based aftercare intervention program, specifically structured for the needs of chronic low back pain (CLBP) patients, leeds to a better rehabilitation outcome in comparison to current usual aftercare (IRENA) and a control group that is given an educational booklet in view of pain-conditioned functional ability and back pain episodes.
Methods/Design:
A multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation and twelve month after dismissal form rehabilitation into the aftercare program.
Discussion:
Special methodological and logistic challenges are to be mastered in this trial, which accrue from the engagement of aftercare interventions to their residential district and the fact the fact that the proportion of patients, who take part in aftercare programs, is low. The usability of the aftercare program lies in the transference into the routine care and is also given by developed manuals with structured contents, media and material for organisation assistance as well as training draughts for practise therapists in the aftercare.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| a) educational booklet | Active comparator | Other: educational booklet |
| b) IRENA | Active comparator | Other: IRENA |
| c) RÜCKGEWINN | Experimental | Other: RÜCKGEWINN |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- M51.2 - M51.4
- M51.8 - M51.9
- M53.8 - M53.9
- M54.5, M54.8 - M54.9
- M54.4 (if radicular symptoms are not dominating)
Key exclusion criteria (9 listed)
- specific reason for back pain, based on a clear cause or diagnosis, which could sufficiently explain its extent (e.g. radicular symptomatic, myelopathesis, inflammatory changes in the spinal column etc.)
- already carried out operation on the spine within the last year
- additional serious psychic diagnosis
- uncorrected serious visual and acoustic disability
- seriously reduced health status (other diseases) with considerable reduction of dexterity
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 |
|---|---|---|
| educational bookletParticipants will receive an educational booklet and the advice to return to normal activities as soon as possible from their rehabilitation practitioner in their dismissal examination. As educational booklet the German version of the "back book" of Burton et al. was chosen. This booklet provides information about the new approach to back pain, causes of back pain, dealing with an attack of back pain, risk factors for development of chronic back pain and the role of activity. All information that is provided is in accordance with actual scientific knowledge and is based on a bio-psycho-social model of back pain like described in Waddell. | Other | a) educational booklet |
| IRENAParticipants will be introduced into the normal IRENA program (in German: Intensivierte Rehabilitationsnachsorge), which is usual care in Germany. Every patient will be assigned to a certified aftercare facility near their residential area. Aftercare practitioners and patients can compile an individual therapeutic package from certain appointed therapeutic services. Predominantly resistance training, gymnastics, aquatic exercise, back school and recreation exercises are prescribed by the physicians for aftercare. Most therapies are carried out in open access groups of at least 6 patients without being specific for medical indication. In the IRENA program it is possible to pass the intended 24 exercise sessions with different frequency per week. Usually participants do two or three exercise sessions per week with duration of 90 to 120 minutes per session. Every aftercare facility offers certain therapy combinations at different days in week. | Other | b) IRENA |
| RÜCKGEWINNFor long term sustainability and the enhancement of intensity of the rehabilitation process this investigational aftercare intervention shows formal and didactic divergences from standard programmes in rehabilitation aftercare. Three important areas for multidimensional interventions are targeted: attitude and behaviour change concerning back pain, guidance to health enhancing physical activity, improvement of health related physical fitness. Every 90 minutes taking exercise session contains parts for mediation of knowledge, for behavioural modulation and for physical exercises and interlocks them in the mediation process. To take the time into account that is necessary for the process of behavioural change RÜCKGEWINN is planned for duration of six months in one session weekly for 26 weeks. | Other | c) RÜCKGEWINN |
Primary outcome
Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.)
Time frame: one year
4 secondary outcomes
Graded chronic pain (GCPS, Von Korff et al. 1992)
Time frame: one year
Catastrophizing (KPI-AE KRSS, Hasenbring 1994)
Time frame: one year
Fear avoidance Beliefs (TSK-DE, Schaub et al. 2004)
Time frame: one year
Physical activity (Freiburger FB, Frey et al. 1999)
Time frame: one year
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 20 Aug 2012.
- Derived from this study: PubMed 21083918Hentschke C, Hofmann J, Pfeifer K. A bio-psycho-social exercise program (RUCKGEWINN) for chronic low back pain in rehabilitation aftercare--study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2010 Nov 17;11:266. doi: 10.1186/1471-2474-11-266.
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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.
Klaus Pfeifer, Prof. Dr. principal investigator
Institute of Sport Science and Sport / University of Erlangen-Nürnberg
Christian Hentschke, Dipl. Sportwiss. study director
Institute of Sport Science and Sport / University of Erlangen-Nürnberg
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing educational booklet, IRENA and RÜCKGEWINN in people with Low Back Pain, run by University of Erlangen-Nürnberg at 6 sites 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 6 inclusion and 9 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 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070849, which also lists 1 linked publication.
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 20 Aug 2012.