NCT03393429|Completed
Training Therapy for the Prevention of Back Pain
Training Therapy for the Secondary and Tertiary Prevention of Backache and Low Back Pain: A Randomized Controlled Pilot Study
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Training Therapy for the Secondary and Tertiary Prevention of Backache and Low Back Pain: A Randomized Controlled Pilot Study
Sponsor study identifier
interventional
33
1 country
1
Study Start
November 1, 2017
Actual (reported)Primary Completion
November 1, 2018
Actual (reported)Study Completion
February 1, 2019
Actual (reported)Work place related (lower) back pain in medical personnel is limiting to workability. Even though occupational prevention programs are increasingly established, data on the effectiveness of training interventions offered at work-sites is largely missing. In this randomized, investigator-blind, controlled feasibility study we aim to compare the effectiveness of device assisted training therapy in comparison to a general recommendation "to stay active" or group gymnastics in terms of pain frequency and intensity (main outcome). Additional outcome variables are: quality of life, psychological well-being, work efficiency, of sick-leave days. Eligible employees (2 x 30) of the General Hospital of Vienna (AKH) over the age of 45 years suffering from (lower) back pain (\>30 days/last year) of intensity ≥ 3 (numeric scale 0-10) will be included in two parallel groups. Group I starts with a device (DAVID) assisted training (40 training sessions; 2x / week) of the core trunk musculature. Group II gets instructions and an advice on how to "stay active" during the first 6 months. Assessment will be conducted before and after these 6 months; then groups are switched, thus, study subjects act as their own controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2017
Actual (reported)January 3, 2018
Actual (reported)January 8, 2018
Actual (reported)November 1, 2018
Actual (reported)February 1, 2019
Actual (reported)Pain Frequency
Incidence of pain-days and pain-intensity
6 months
Sick-Leave
6 months
Group I: Training assisted by DAVID devices
Group II: Training based on "stay active" recommendations
DAVID device assisted training under supervision
training recommendation to "stay active"
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Department of Physical Medicine, Rehabilitation and Occupational Medicine
Vienna, 1090, Austria
Gerold Ebenbichler, Prof. Dr.
University Department of Physical Medicine, Rehabilitation and Occupational Medicine
33 participants (actual enrollment reported by the registry).
First Submitted
January 3, 2018
First Posted
January 8, 2018
Study Start
November 1, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 1, 2018
Actual (reported)Study Completion
February 1, 2019
Actual (reported)Last Updated
October 20, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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