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NCT02251444 Clinical Trial

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

Chronic Low Back Pain Clinical Trial

Official title:
Emotionsregulation Und Bewältigungsverhalten in Zusammenhang Mit Ambulanter Rehabilitation Oder Physikalischer Therapie Bei Chronischem Rückenschmerz

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02251444
Other study ID # rehabilitation program LBP
Secondary ID
Status Terminated
Phase N/A
First received July 7, 2014
Last updated August 3, 2016
Start date May 2014

Study information
Verified date August 2016
Source Karl Landsteiner Institute of Remobilization and Functional Health
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical 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.

Standardised questionnaires are used for investigation

Description:

Emotionsregulations-Inventar ERI Emotion Regulation Questionnaire ERQ Positive and Negative Affect Schedule PANAS Brief Symptom Inventory BSI-18

Recruitment information / eligibility
Status Terminated
Enrollment 42
Est. completion date
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• outpatient rehabilitation program

• physical therapy

Locations
Country Name City State
Austria Karl Landsteiern Institute of Remobilisation and Functional Health Vienna

Sponsors (1)
Lead Sponsor Collaborator
Karl Landsteiner Institute of Remobilization and Functional Health

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Emotion regulation before and after treatment Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI 6-8 months No
Secondary Isometric muscle strenght before and after treatment The maximum voluntary isometric muscle strength of the lumbar extensor muscles will be assessed 6-8 months No
Secondary Pain in the spine before and after treatment Pain will be assessed with Visual Analogue Scale 6-8 months No
Secondary Emotion regulation before and after treatment Emotion regulation will be assessed with the Emotion Regulation Questionnaire ERQ 6-8 months No
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