NCT02251444

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

2.3 years

First QC Date

July 7, 2014

Last Update Submit

August 3, 2016

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Emotion regulation before and after treatment

    Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI

    6-8 months

Secondary Outcomes (3)

  • Isometric muscle strenght before and after treatment

    6-8 months

  • Pain in the spine before and after treatment

    6-8 months

  • Emotion regulation before and after treatment

    6-8 months

Study Arms (2)

outpatient rehabilitation program

EXPERIMENTAL

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

Procedure: outpatient rehabilitation program

physical therapy

ACTIVE COMPARATOR

prescribed physical therapy

Procedure: physical therapy

Interventions

outpatient rehabilitation programPROCEDURE
outpatient rehabilitation program
physical therapyPROCEDURE
physical therapy

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karl Landsteiern Institute of Remobilisation and Functional Health

Vienna, Vienna, 1100, Austria

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim. Univ. prof. Dr. Michael Quittan

Study Record Dates

First Submitted

July 7, 2014

First Posted

September 29, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

AU(1)