Low Back PainPASTORNCT02056951
Interprofessional Rehabilitation for Adults With Chronic Non-specific Low Back Pain
A study testing Multidisciplinary rehabilitation and Interprofessional rehabilitation in people with Low Back Pain, run by University of Erlangen-Nürnberg at 4 sites in Germany.
Trial summary
The primary aim of the study is to analyse the long-term effectiveness of an interprofessional and interdisciplinary rehabilitation program named "PASTOR", with a biopsychosocial approach for participants with chronic non-specific low back pain (CLBP) compared to the standard inpatient multidisciplinary orthopaedic… 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?
- Multidisciplinary rehabilitation and Interprofessional rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 4 sitesGermany
- Study dates
- Jan 2008to Mar 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- M51.2 Other specified intervertebral disc displacement
- M51.3 Other specified intervertebral disc degeneration
- M51.4 Schmorl's nodes
- M51.8 Other specified intervertebral disc disorders
- M51.9 Intervertebral disc disorder, unspecified
- M53.8 Other specified dorsopathies
Show all 12Show fewer
- M53.9 dorsopathy, unspecified
- M54.4 Lumbago with sciatica
- M54.5 Low back pain
- M54.6 Pain in thoracic spine
- M54.8 Other dorsalgia
- M54.9 Dorsalgia, unspecified
Who cannot join
- age below 18 years or over 65 years
- specific underlying diagnosis of back pain (e. g. radicular symptoms, myelopathy)
- considerably reduced health status (e.g. comorbidity)
- considerably reduced sight and hearing (not corrected)
- severe psychiatric condition as secondary diagnosis
- inability to speak German
- current application for early retirement or invalidity pension (§51 SG V - german law)
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Frankenklinik
Bad Kissingen, Bavaria, 97688
Klinik Franken, Reha-Zentrum Bad Steben
Bad Steben, Bavaria, 95138
Asklepios Klinik Schaufling
Schaufling, Bavaria, 94571
University of Würzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences
Würzburg, Bavaria, 97070
About this study
Official title: Interprofessional Biopsychosocial Rehabilitation to Optimize Inpatient Multidisciplinary Orthopedic Rehabilitation for Chronic Low Back Pain
The primary aim of the study is to analyse the long-term effectiveness of an interprofessional and interdisciplinary rehabilitation program named "PASTOR", with a biopsychosocial approach for participants with chronic non-specific low back pain (CLBP) compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program PASTOR would result in a significantly higher increase in functional ability 12 months after completion of the program in comparison to the standard inpatient MOR. The investigators further hypothesize that PASTOR would lead to significantly larger improvements regarding pain-related cognitions, pain coping strategies, physical activity, health-related quality of life, and back pain episodes compared to the standard inpatient MOR.
- Conditions
- Low Back Pain
- Being tested
- Multidisciplinary rehabilitation, Interprofessional rehabilitation
- Keywords
- Rehabilitation, Treatment Outcome, Interprofessional Relations, Interdisciplinary Communication, Behavioural Exercise Therapy, Cognitive Therapy, Health Education, Workplace related information, Multicenter Study
- Medical subject headings
- Low Back Pain, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary rehabilitationProcedure or surgery
Multidisciplinary rehabilitation includes interventions from the physical and psychological dimensions:
- health education
- exercise therapy
- back school
- physical treatments
- psychological interventions in groups and individual counselling
- rehabilitation/social counselling.
Interprofessional rehabilitationProcedure or surgery
Interprofessional rehabilitation includes also interventions from the physical and psychological dimensions:
- education about low back pain
- behavioural exercise therapy
- coping with pain
- relaxation
- work related informations
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary rehabilitation | Active comparator | The central objective of inpatient multidisciplinary orthopedic rehabilitation (MOR) is to improve functional health with the main focus on restoring and improving work ability. A MOR lasts on average 23 days with a total extent of therapy of 48 hours on average. MOR is provided by a multiprofessional team consisting of physicians, psychologists, sport therapists, physiotherapists, occupational therapists, masseurs, social workers, dieticians and nurses. The interventions are carried out mainly in open groups. Receives: Procedure: Multidisciplinary rehabilitation |
| Interprofessional rehabilitation | Experimental | The central objective of the interprofessional rehabilitation (PASTOR) is the development of active self-management of chronic non-specific low back pain. PASTOR is matched to the MOR with respect to the total duration and total extent of therapy, the included professions and the interventions dimensions (physical, psychological). The differences between PASTOR and MOR are characterized by, a) an integrative combination of profession related modules within a comprehensive and consistent treatment approach, b) an interprofessional and collaborative teamwork based on profession related modules, c) the use of standardized methods, media and materials by all professions in the therapeutic team d) a highly structured and detailed manual for the entire treatment process. The interventions are carried in fixed groups with eight to twelve participants. Receives: Procedure: Interprofessional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months
The FFbH-R consists of twelve items with a three-stage answering scale (2=yes; 1=yes, but with difficulty; 0=no, or only with assistance). The summary score describes the low back pain associated functional ability in activities of daily living (e.g. "Can you wash and dry yourself from head to toe?") in adults on a scale of 0% (minimum functional ability) to 100% (maximum functional ability).
Kohlmann Th \& Raspe H (1996). Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Die Rehabilitation, 34, I-VIII.
Measured: baseline, one year
Secondary outcomes (6)
Health-related Quality of Life (SF-12)
To assess mental and physical health status during the past four weeks.
Bullinger M \& Kirchberger I (1998). SF-36, Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe.
Measured: baseline, three weeks, one year
Numerical rating scale (NRS)
Three items to assess the pain intensity reported by participants at the moment, as well as during the last six months (mean and maximum pain).
Nagel B, Gerbershagen HU, Lindena G \& Pfingsten M (2002). Entwicklung und empirische Überprüfung des Deutschen Schmerzfragebogens der DGSS. Schmerz, 16 (4), 263-270.
Measured: baseline, three weeks, one year
Freiburg Questionnaire of physical activity (FFkA)
The FQPA measures the amount of physical activity in different contexts performed by the participants: occupational setting (rating: intensive movement, moderate movement, mostly sitting) as well as leisure time physical activity (e.g. gardening, stair-climbing, habitual walking and cycling, sports). It consists of eight items.
Frey I, Berg A, Grathwohl D \& Keul J (1999). Freiburger Fragebogen zur körperlichen Aktivität - Entwicklung, Prüfung und Anwendung. Sozial- und Präventivmedizin, 44, 55-64.
Measured: baseline, one year
Pain Management Questionnaire (FESV)
Questionnaire to assess cognitive and behavioral pain coping strategies.
Geissner E (2001). Fragebogen zur Erfassung der Schmerzverarbeitung (FESV). Manual. Göttingen: Hogrefe.
Measured: baseline, three weeks, one year
Avoidance-Endurance Questionnaire (AEQ)
Questionnaire to assess fear-avoidance response pattern and avoidance-endurance response pattern to pain.
Hasenbring MI, Hallner D \& Rusu AC (2009). Fear-avoidance- and endurance-related responses to pain: development and validation of the Avoidance-Endurance Questionnaire (AEQ). Eur J Pain, 13 (6), 620-628.
Measured: baseline, three weeks, one year
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 weeks
The FFbH-R consists of twelve items with a three-stage answering scale (2=yes; 1=yes, but with difficulty; 0=no, or only with assistance). The summary score describes the low back pain associated functional ability in activities of daily living (e.g. "Can you wash and dry yourself from head to toe?") in adults on a scale of 0% (minimum functional ability) to 100% (maximum functional ability).
Kohlmann Th \& Raspe H (1996). Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Die Rehabilitation, 34, I-VIII.
Measured: baseline, three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionMar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Rentenversicherung, University of Wuerzburg
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
- Investigators
- Klaus Pfeifer, Prof. Dr., Study chair, Friedrich-Alexander-University Erlangen-Nürnberg, Institute of Sport Science and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056951
- Sponsor's protocol ID
- 0421-FSCP-0529
- Acronym
- PASTOR
- Status last verified
- Sep 2015
- First submitted
- 4 Feb 2014
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Semrau J, Hentschke C, Buchmann J, Meng K, Vogel H, Faller H, Bork H, Pfeifer K. Long-term effects of interprofessional biopsychosocial rehabilitation for adults with chronic non-specific low back pain: a multicentre, quasi-experimental study. PLoS One. 2015 Mar 13;10(3):e0118609. doi: 10.1371/journal.pone.0118609. eCollection 2015.
PubMed 25768735
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interprofessional Biopsychosocial Rehabilitation to Optimize Inpatient Multidisciplinary Orthopedic Rehabilitation for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02056951
- Acronym / sponsor ID
- PASTOR / 0421-FSCP-0529
- Conditions
- Low Back Pain
- Keywords
- Rehabilitation, Treatment Outcome, Interprofessional Relations, Interdisciplinary Communication, Behavioural Exercise Therapy, Cognitive Therapy, Health Education, Workplace related information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- Deutsche Rentenversicherung, University of Wuerzburg
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Feb 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.
The primary aim of the study is to analyse the long-term effectiveness of an interprofessional and interdisciplinary rehabilitation program named "PASTOR", with a biopsychosocial approach for participants with chronic non-specific low back pain (CLBP) compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program PASTOR would result in a significantly higher increase in functional ability 12 months after completion of the program in comparison to the standard inpatient MOR. The investigators further hypothesize that PASTOR would lead to significantly larger improvements regarding pain-related cognitions, pain coping strategies, physical activity, health-related quality of life, and back pain episodes compared to the standard inpatient MOR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary rehabilitation | Active comparator | Procedure: Multidisciplinary rehabilitationThe central objective of inpatient multidisciplinary orthopedic rehabilitation (MOR) is to improve functional health with the main focus on restoring and improving work ability. A MOR lasts on average 23 days with a total extent of therapy of 48 hours on average. MOR is provided by a multiprofessional team consisting of physicians, psychologists, sport therapists, physiotherapists, occupational therapists, masseurs, social workers, dieticians and nurses. The interventions are carried out mainly in open groups. |
| Interprofessional rehabilitation | Experimental | Procedure: Interprofessional rehabilitationThe central objective of the interprofessional rehabilitation (PASTOR) is the development of active self-management of chronic non-specific low back pain. PASTOR is matched to the MOR with respect to the total duration and total extent of therapy, the included professions and the interventions dimensions (physical, psychological). The differences between PASTOR and MOR are characterized by, a) an integrative combination of profession related modules within a comprehensive and consistent treatment approach, b) an interprofessional and collaborative teamwork based on profession related modules, c) the use of standardized methods, media and materials by all professions in the therapeutic team d) a highly structured and detailed manual for the entire treatment process. The interventions are carried in fixed groups with eight to twelve participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- M51.2 Other specified intervertebral disc displacement
- M51.3 Other specified intervertebral disc degeneration
- M51.4 Schmorl's nodes
- M51.8 Other specified intervertebral disc disorders
- M51.9 Intervertebral disc disorder, unspecified
Key exclusion criteria (7 listed)
- age below 18 years or over 65 years
- specific underlying diagnosis of back pain (e. g. radicular symptoms, myelopathy)
- considerably reduced health status (e.g. comorbidity)
- considerably reduced sight and hearing (not corrected)
- severe psychiatric condition as secondary diagnosis
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 |
|---|---|---|
| Multidisciplinary rehabilitationMultidisciplinary rehabilitation includes interventions from the physical and psychological dimensions: * health education * exercise therapy * back school * physical treatments * psychological interventions in groups and individual counselling * rehabilitation/social counselling. | Procedure or surgery | Multidisciplinary rehabilitation |
| Interprofessional rehabilitationInterprofessional rehabilitation includes also interventions from the physical and psychological dimensions: * education about low back pain * behavioural exercise therapy * coping with pain * relaxation * work related informations | Procedure or surgery | Interprofessional rehabilitation |
Primary outcome
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months
Time frame: baseline, one year
The FFbH-R consists of twelve items with a three-stage answering scale (2=yes; 1=yes, but with difficulty; 0=no, or only with assistance). The summary score describes the low back pain associated functional ability in activities of daily living (e.g. "Can you wash and dry yourself from head to toe?") in adults on a scale of 0% (minimum functional ability) to 100% (maximum functional ability). Kohlmann Th \& Raspe H (1996). Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Die Rehabilitation, 34, I-VIII.
6 secondary outcomes
Health-related Quality of Life (SF-12)
Time frame: baseline, three weeks, one year
Numerical rating scale (NRS)
Time frame: baseline, three weeks, one year
Freiburg Questionnaire of physical activity (FFkA)
Time frame: baseline, one year
Pain Management Questionnaire (FESV)
Time frame: baseline, three weeks, one year
Avoidance-Endurance Questionnaire (AEQ)
Time frame: baseline, three weeks, one year
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 weeks
Time frame: baseline, three weeks
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 9 Sep 2015.
- Results publication: PubMed 25768735Semrau J, Hentschke C, Buchmann J, Meng K, Vogel H, Faller H, Bork H, Pfeifer K. Long-term effects of interprofessional biopsychosocial rehabilitation for adults with chronic non-specific low back pain: a multicentre, quasi-experimental study. PLoS One. 2015 Mar 13;10(3):e0118609. doi: 10.1371/journal.pone.0118609. eCollection 2015.
- Homepage: Research funding for care-oriented research "Chronic diseases and patient orientation"Link 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.
Klaus Pfeifer, Prof. Dr. study chair
Friedrich-Alexander-University Erlangen-Nürnberg, Institute of Sport Science and Sport
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary rehabilitation and Interprofessional rehabilitation in people with Low Back Pain, run by University of Erlangen-Nürnberg at 4 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 12 inclusion and 7 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 9 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 4 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.
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?
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months (time frame: baseline, 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 NCT02056951, 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 9 Sep 2015.