Chronic Low Back PainNCT02251444
Regulation of Emotions and Coping Behaviour in Patients With Chronic Recurrent Low Back Pain
A study testing outpatient rehabilitation program and physical therapy in people with Chronic Low Back Pain, run by Karl Landsteiner Institute of Remobilization and Functional Health at 1 site in Austria.
Trial summary
This study investigates effects of a multidisciplinary rehabilitation program or physical therapy in patients with chronic low back pain on emotion regulation and coping behaviour. Hypothesis: Significant differences of negative emotions pre and post treatment and between groups after intervention. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- outpatient rehabilitation program and physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- May 2014to Aug 2016
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic low back pain > 3 months
- VAS >= 2
- understanding of german language
Who cannot join
- retired
- psychiatric disorders
- dementia
- sick headache
- chronic pain disease other than chronic low back pain
- patients with general contraindications of the therapy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Karl Landsteiern Institute of Remobilisation and Functional Health
Vienna, State of Vienna, 1100
About this study
Official title: Emotionsregulation Und Bewältigungsverhalten in Zusammenhang Mit Ambulanter Rehabilitation Oder Physikalischer Therapie Bei Chronischem Rückenschmerz
This study investigates effects of a multidisciplinary rehabilitation program or physical therapy in patients with chronic low back pain on emotion regulation and coping behaviour.
Hypothesis: Significant differences of negative emotions pre and post treatment and between groups after intervention.
Standardised questionnaires are used for investigation
Read the detailed description
Emotionsregulations-Inventar ERI Emotion Regulation Questionnaire ERQ Positive and Negative Affect Schedule PANAS Brief Symptom Inventory BSI-18
- Conditions
- Chronic Low Back Pain
- Being tested
- outpatient rehabilitation program, physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient rehabilitation programProcedure or surgery
physical therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| outpatient rehabilitation program | Experimental | whole-body resistance training, psychological interventions, sessions for information related to ergonomics and healthy alimentation Receives: Procedure: outpatient rehabilitation program |
| physical therapy | Active comparator | prescribed physical therapy Receives: Procedure: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion regulation before and after treatment
Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI
Measured: 6-8 months
Secondary outcomes (3)
Isometric muscle strenght before and after treatment
The maximum voluntary isometric muscle strength of the lumbar extensor muscles will be assessed
Measured: 6-8 months
Pain in the spine before and after treatment
Pain will be assessed with Visual Analogue Scale
Measured: 6-8 months
Emotion regulation before and after treatment
Emotion regulation will be assessed with the Emotion Regulation Questionnaire ERQ
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2016
Why it stopped: recruitment problems in the controle group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner Institute of Remobilization and Functional Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Quittan, Karl Landsteiner Institute of Remobilization and Functional Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251444
- Sponsor's protocol ID
- rehabilitation program LBP
- Status last verified
- Aug 2016
- First submitted
- 7 Jul 2014
- Last updated
- 4 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotionsregulation Und Bewältigungsverhalten in Zusammenhang Mit Ambulanter Rehabilitation Oder Physikalischer Therapie Bei Chronischem Rückenschmerz
- ClinicalTrials.gov ID
- NCT02251444
- Acronym / sponsor ID
- rehabilitation program LBP
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment problems in the controle group
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karl Landsteiner Institute of Remobilization and Functional HealthUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2016 (actual)
- First posted
- 29 Sep 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.
This study investigates effects of a multidisciplinary rehabilitation program or physical therapy in patients with chronic low back pain on emotion regulation and coping behaviour.
Hypothesis: Significant differences of negative emotions pre and post treatment and between groups after intervention.
Standardised questionnaires are used for investigation
Detailed description
Emotionsregulations-Inventar ERI Emotion Regulation Questionnaire ERQ Positive and Negative Affect Schedule PANAS Brief Symptom Inventory BSI-18
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| outpatient rehabilitation program | Experimental | Procedure: outpatient rehabilitation programwhole-body resistance training, psychological interventions, sessions for information related to ergonomics and healthy alimentation |
| physical therapy | Active comparator | Procedure: physical therapyprescribed physical therapy |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic low back pain > 3 months
- VAS >= 2
- understanding of german language
Key exclusion criteria (6 listed)
- retired
- psychiatric disorders
- dementia
- sick headache
- chronic pain disease other than chronic low back pain
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 |
|---|---|---|
| outpatient rehabilitation program | Procedure or surgery | outpatient rehabilitation program |
| physical therapy | Procedure or surgery | physical therapy |
Primary outcome
Emotion regulation before and after treatment
Time frame: 6-8 months
Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI
3 secondary outcomes
Isometric muscle strenght before and after treatment
Time frame: 6-8 months
Pain in the spine before and after treatment
Time frame: 6-8 months
Emotion regulation before and after treatment
Time frame: 6-8 months
Results and safety
The study was stopped early (reason given: recruitment problems in the controle group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outpatient rehabilitation program and physical therapy in people with Chronic Low Back Pain, run by Karl Landsteiner Institute of Remobilization and Functional Health at 1 site in Austria.
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 3 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: stopped early, as of the sponsor's last update on 4 Aug 2016. 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 Austria. 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 was stopped early (reason given: recruitment problems in the controle group). Results are not available in the source record.
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?
Emotion regulation before and after treatment (time frame: 6-8 months). 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 4 Aug 2016.