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

August 3, 2016 updated by: Michael Quittan, Karl Landsteiner Institute of Remobilization and Functional Health

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1100
        • Karl Landsteiern Institute of Remobilisation and Functional Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: outpatient rehabilitation program
whole-body resistance training, psychological interventions, sessions for information related to ergonomics and healthy alimentation
Procedure: outpatient rehabilitation program
Active Comparator: physical therapy
prescribed physical therapy
Procedure: physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion regulation before and after treatment
Time Frame: 6-8 months
Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI
6-8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isometric muscle strenght before and after treatment
Time Frame: 6-8 months
The maximum voluntary isometric muscle strength of the lumbar extensor muscles will be assessed
6-8 months
Pain in the spine before and after treatment
Time Frame: 6-8 months
Pain will be assessed with Visual Analogue Scale
6-8 months
Emotion regulation before and after treatment
Time Frame: 6-8 months
Emotion regulation will be assessed with the Emotion Regulation Questionnaire ERQ
6-8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karl Landsteiner Institute of Remobilization and Functional Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rehabilitation program LBP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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