AzTrials
AzTrials

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
Search all trials

Trial summary

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. Read more about this study

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
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.

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 groupRoleWhat they receive
Control GroupActive comparatorNot described
Receives: Behavioral: Usual Behavioral Medical Rehabilitation
Intervention GroupExperimentalNot 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)

    Measured: one year

  5. 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

  6. Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)

    Measured: one year

  7. Depression (PHQ-D) (Löwe et al., 2002)

    Measured: one year

  8. Perceived Stress scale (Cohen, Williamson, 1988)

    Measured: one year

  9. 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

  10. Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)

    Measured: one year

  11. Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)

    Measured: one year

  12. 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.

  1. First posted16 Aug 2012 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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

Questions about this trial

What is this clinical trial studying?

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.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in