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Regulation of Emotions and Coping Behaviour in Patients With Chronic Recurrent Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
outpatient rehabilitation program
physical therapy
Sponsored by
Karl Landsteiner Institute of Remobilization and Functional Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic low back pain > 3 months
  • VAS >= 2
  • understanding of german language

Exclusion Criteria:

  • retired
  • psychiatric disorders
  • dementia
  • sick headache
  • chronic pain disease other than chronic low back pain
  • patients with general contraindications of the therapy

Sites / Locations

  • Karl Landsteiern Institute of Remobilisation and Functional Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

outpatient rehabilitation program

physical therapy

Arm Description

whole-body resistance training, psychological interventions, sessions for information related to ergonomics and healthy alimentation

prescribed physical therapy

Outcomes

Primary Outcome Measures

Emotion regulation before and after treatment
Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI

Secondary Outcome Measures

Isometric muscle strenght before and after treatment
The maximum voluntary isometric muscle strength of the lumbar extensor muscles will be assessed
Pain in the spine before and after treatment
Pain will be assessed with Visual Analogue Scale
Emotion regulation before and after treatment
Emotion regulation will be assessed with the Emotion Regulation Questionnaire ERQ

Full Information

First Posted
July 7, 2014
Last Updated
August 3, 2016
Sponsor
Karl Landsteiner Institute of Remobilization and Functional Health
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1. Study Identification

Unique Protocol Identification Number
NCT02251444
Brief Title
Regulation of Emotions and Coping Behaviour in Patients With Chronic Recurrent Low Back Pain
Official Title
Emotionsregulation Und Bewältigungsverhalten in Zusammenhang Mit Ambulanter Rehabilitation Oder Physikalischer Therapie Bei Chronischem Rückenschmerz
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
recruitment problems in the controle group
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karl Landsteiner Institute of Remobilization and Functional Health

4. Oversight

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
outpatient rehabilitation program
Arm Type
Experimental
Arm Description
whole-body resistance training, psychological interventions, sessions for information related to ergonomics and healthy alimentation
Arm Title
physical therapy
Arm Type
Active Comparator
Arm Description
prescribed physical therapy
Intervention Type
Procedure
Intervention Name(s)
outpatient rehabilitation program
Intervention Type
Procedure
Intervention Name(s)
physical therapy
Primary Outcome Measure Information:
Title
Emotion regulation before and after treatment
Description
Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI
Time Frame
6-8 months
Secondary Outcome Measure Information:
Title
Isometric muscle strenght before and after treatment
Description
The maximum voluntary isometric muscle strength of the lumbar extensor muscles will be assessed
Time Frame
6-8 months
Title
Pain in the spine before and after treatment
Description
Pain will be assessed with Visual Analogue Scale
Time Frame
6-8 months
Title
Emotion regulation before and after treatment
Description
Emotion regulation will be assessed with the Emotion Regulation Questionnaire ERQ
Time Frame
6-8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic low back pain > 3 months VAS >= 2 understanding of german language Exclusion Criteria: retired psychiatric disorders dementia sick headache chronic pain disease other than chronic low back pain patients with general contraindications of the therapy
Facility Information:
Facility Name
Karl Landsteiern Institute of Remobilisation and Functional Health
City
Vienna
ZIP/Postal Code
1100
Country
Austria

12. IPD Sharing Statement

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Regulation of Emotions and Coping Behaviour in Patients With Chronic Recurrent Low Back Pain

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