Chronic Low Back PainVBTNCT01666639

Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain

A study testing Behavioral Medical Rehabilitation plus behavioral exercise therapy and Usual Behavioral Medical Rehabilitation in people with Chronic Low Back Pain, run by University of Erlangen-Nürnberg at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Behavioral Medical Rehabilitation plus behavioral exercise therapy and Usual Behavioral Medical Rehabilitation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 351 participants
Where: 3 sitesGermany
Study dates: Mar 2011to Dec 2013
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

F45.4 Persistent somatoform pain disorder
F45.41 Chronic pain disorder with somatic and psychological factors
F54 Psychological and behavioural factors associated with disorders or diseases classified elsewhere
M51.2 Other specified intervertebral disc displacement
M51.3 Other specified intervertebral disc degeneration
M51.4 Schmorl's nodes

Show all 16Show fewer

M51.8 Other specified intervertebral disc disorders
M51.9 Intervertebral disc disorder, unspecified
M53.8 Other specified dorsopathies
M53.9 dorsophathy, 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
R52.2 Other chronic pain

Who cannot join

distinct specific diagnosis for back pain (e.g. radicular symptoms, myelopathy)
severely limited health status (comorbidity)
serious impairment of vision and hearing (not corrected)
serious psychiatric codiagnosis (exkl. see inclusion criteria)
inability to speak german
pension claim (§51 SGB V - german law)

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

Paracelsus-Klinik an der Gande
Bad Gandersheim, Lower Saxony, 37581
Klinik Weser
Bad Pyrmont, Lower Saxony, 31812
Institute of Sport Science and Sport
Erlangen, Bavaria, 91058

Other trials in Germany

About this study

Official title: Behavioral Exercise Therapy to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Non-specific Low Back Pain

Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain has proven its short-term effectiveness. Exercise therapy plays a major role in such a combination of treatments. There is a considerable need to develop theory-based exercise interventions which foster a long-term adherence to physical activity. Furthermore, an integration of behavioral elements such as coping competencies regarding back pain is needed. It is not yet clear, which specific part of multidisciplinary rehabilitation causes its effects. The role of exercise therapy has yet to be investigated. Aim of this study is the implementation of a standardized behavioral exercise therapy into an existing behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is that the participation in the behavioral exercise therapy leads to greater short- and long-term improvements in functional capacity compared to the usual care.

Conditions: Chronic Low Back Pain
Being tested: Behavioral Medical Rehabilitation plus behavioral exercise therapy, Usual Behavioral Medical Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral Medical Rehabilitation plus behavioral exercise therapyBehavioural
The Intervention Group is characterized by the same treatment as in the control group, plus a modification of the exercise therapy. An "Behavioral Exercise Therapy" (BET) is implemented in the usual care. The Behavioral Exercise Therapy is based on a goal-oriented and systematic combination of knowledge-, behavior-, and exercise-related elements. It had been developed prior as part of a multidisciplinary treatment and was adapted for this study. The Aims of BET are gradual improvements of individual coping competencies and self-management regarding back pain as well as long-term adherence to physical activity.
Usual Behavioral Medical RehabilitationBehavioural
The Behavioral Medical Rehabilitation (BMR), which is in this case the control group (usual care), consists of usual orthopedic medical care, exercise therapy, individual physiotherapy, psychological treatment elements (e.g. a pain management group), occupational therapy and back school. Pain medication is given if necessary. For the most part, the psychological elements draw a distinction between more "traditional" concepts or orthopedic rehabilitation and the BMR. The pain management group with its cognitive-behavioral principles comprises 9 sessions of 90 minutes each.

Study groups in NCT01666639
Study group	Role	What they receive
Control Group	Active comparator	Not described Receives: Behavioral: Usual Behavioral Medical Rehabilitation
Intervention Group	Experimental	Not described Receives: Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)
The Hannover Functional Ability Questionnaire surveys the subjective estimate of a person of his or her functional ability in the context of physical activities of daily living. The Questionnaire has 12 Items. The participant is asked whether he or she is able to perform activities (e.g. to put on and pull off one's socks) and rates each on a 3-point scale (1=yes, 2=yes, but with trouble), 3=no, or only with help).
Measured: one year

Secondary outcomes (12)

Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)
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.
Measured: one year
Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)
Three items to assess the pain intensity felt by participants at the moment, as well as during the last six months (mean and maximum pain).
Measured: one year
Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)
Six items to assess the number of days with pain during the last six months, the history of pain and the functional disability due to pain.
Measured: one year
Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)
Measured: one year
HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)
The HAPA variables include a stage assessment of behaviour change: Have you performed moderate physical for 30 minutes or longer on a minimum of 3 days per week? (rating: No, and I don't intend to do so - No, but I am currently thinking about that - No, but I strongly intend to do so - Yes, but it is difficult to me - Yes and it is easy to me) Further more, the HAPA variables include a validation item ("Since when are you regularly active as you are now?") and sets of items about the participants' intention, self-efficacy, action and coping planning, risk perception, expectations of consequences of physical activity behaviour and action control regarding physical activity. See Schwarzer et al., 2011 (Rehabilitation psychology 56(3), 161-170) for more details. Furthermore, experiences with physical activity are included (Fleig et al., 2011).
Measured: one year
Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)
Measured: one year
Depression (PHQ-D) (Löwe et al., 2002)
Measured: one year
Perceived Stress scale (Cohen, Williamson, 1988)
Measured: one year
Attitudes towards performing sports (Brand, 2006)
Four items assess the attitudes towards performing physical activity which are based on cognitions (e.g. "When I think about it, I regard physical activity as: not healthy -- very healthy"). Four items assess the attitudes based on affective judgement (e.g. "When I think about bein physically active, I feel not satisfied -- very satisfied"). Each of the eight items is rated on a 7-point scale in between the two poles.
Measured: one year
Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)
Measured: one year
Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)
Measured: one year
Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Dec 2013

First posted16 Aug 2012 (estimated)
Study startMar 2011
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01666639
Sponsor's protocol ID: 0421-FSCP-Z256
Acronym: VBT
Status last verified: Jan 2014
First submitted: 18 Jun 2012
Last updated: 28 Jan 2014
Results posted: No
Data monitoring committee: No

Publications

Hofmann J, Peters S, Geidl W, Hentschke C, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of a multidisciplinary rehabilitation for chronic non-specific low back pain: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2013 Mar 11;14:89. doi: 10.1186/1471-2474-14-89.
PubMed 23496822
Semrau J, Hentschke C, Peters S, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of multidisciplinary rehabilitation for chronic non-specific low back pain: a randomised controlled trial. BMC Musculoskelet Disord. 2021 May 29;22(1):500. doi: 10.1186/s12891-021-04353-y.
PubMed 34051780

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Exercise Therapy to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Non-specific Low Back Pain
ClinicalTrials.gov ID: NCT01666639
Acronym / sponsor ID: VBT / 0421-FSCP-Z256
Conditions: Chronic Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 351 participants (actual)
Lead sponsor: University of Erlangen-NürnbergUniversity, hospital or other
Collaborators: Deutsche Rentenversicherung
Study start: Mar 2011
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 16 Aug 2012 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Control Group	Active comparator	Behavioral: Usual Behavioral Medical Rehabilitation
Intervention Group	Experimental	Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

F45.4 Persistent somatoform pain disorder
F45.41 Chronic pain disorder with somatic and psychological factors
F54 Psychological and behavioural factors associated with disorders or diseases classified elsewhere
M51.2 Other specified intervertebral disc displacement
M51.3 Other specified intervertebral disc degeneration

Key exclusion criteria (6 listed)

distinct specific diagnosis for back pain (e.g. radicular symptoms, myelopathy)
severely limited health status (comorbidity)
serious impairment of vision and hearing (not corrected)
serious psychiatric codiagnosis (exkl. see inclusion criteria)
inability to speak german

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
Behavioral Medical Rehabilitation plus behavioral exercise therapyThe Intervention Group is characterized by the same treatment as in the control group, plus a modification of the exercise therapy. An "Behavioral Exercise Therapy" (BET) is implemented in the usual care. The Behavioral Exercise Therapy is based on a goal-oriented and systematic combination of knowledge-, behavior-, and exercise-related elements. It had been developed prior as part of a multidisciplinary treatment and was adapted for this study. The Aims of BET are gradual improvements of individual coping competencies and self-management regarding back pain as well as long-term adherence to physical activity.	Behavioural	Intervention Group
Usual Behavioral Medical RehabilitationThe Behavioral Medical Rehabilitation (BMR), which is in this case the control group (usual care), consists of usual orthopedic medical care, exercise therapy, individual physiotherapy, psychological treatment elements (e.g. a pain management group), occupational therapy and back school. Pain medication is given if necessary. For the most part, the psychological elements draw a distinction between more "traditional" concepts or orthopedic rehabilitation and the BMR. The pain management group with its cognitive-behavioral principles comprises 9 sessions of 90 minutes each.	Behavioural	Control Group

Primary outcome

Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)
Time frame: one year
The Hannover Functional Ability Questionnaire surveys the subjective estimate of a person of his or her functional ability in the context of physical activities of daily living. The Questionnaire has 12 Items. The participant is asked whether he or she is able to perform activities (e.g. to put on and pull off one's socks) and rates each on a 3-point scale (1=yes, 2=yes, but with trouble), 3=no, or only with help).

12 secondary outcomes

Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)
Time frame: one year
Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)
Time frame: one year
Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)
Time frame: one year
Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)
Time frame: one year
HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)
Time frame: one year
Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)
Time frame: one year
Depression (PHQ-D) (Löwe et al., 2002)
Time frame: one year
Perceived Stress scale (Cohen, Williamson, 1988)
Time frame: one year
Attitudes towards performing sports (Brand, 2006)
Time frame: one year
Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)
Time frame: one year
Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)
Time frame: one year
Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)
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 28 Jan 2014.
Background: PubMed 23496822Hofmann J, Peters S, Geidl W, Hentschke C, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of a multidisciplinary rehabilitation for chronic non-specific low back pain: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2013 Mar 11;14:89. doi: 10.1186/1471-2474-14-89.
Derived from this study: PubMed 34051780Semrau J, Hentschke C, Peters S, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of multidisciplinary rehabilitation for chronic non-specific low back pain: a randomised controlled trial. BMC Musculoskelet Disord. 2021 May 29;22(1):500. doi: 10.1186/s12891-021-04353-y.
Homepage: Research funding for care-oriented research "Chronic diseases and patient orientation"Link provided by the sponsor.

Related trials for Chronic Low Back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 6 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 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996) (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 NCT01666639, which also lists 2 linked publications.

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 28 Jan 2014.