Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03393429 |
| Other study ID # |
1118/2012 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2017 |
| Est. completion date |
February 1, 2019 |
Study information
| Verified date |
October 2020 |
| Source |
Medical University of Vienna |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
Work place related pain syndromes of the (lower) back pose a major health problem for medical
personnel. Beside the discomfort and limitations of the affected patients, a severe
restriction of their ability to work must be considered.
For secondary prevention of back pain, health promotion programs are recommended. These
consist of psychosocial and ergonomic interventions and, above all, a regular strengthening
of the stabilizing muscle groups. Specific strength and endurance training for the trunk
musculature with appropriate equipment is considered as a useful preventive measure and thus
commonly offered at large corporations, even during working hours of the staff. However, data
clearly demonstrating the effectivity and cost-effectiveness of these interventions is
largely missing.
This pilot study serves several purposes:
On one hand, the feasibility of a randomized, controlled study is to be examined, which is to
prove the effectiveness of the medical training therapy in comparison to a general
recommendation "to stay active" or in comparison to group gymnastics. In particular,
logistical problems in the organization of training therapy and training compliance must be
clarified.
On the other hand, this pilot study serves to generate hypotheses. Several variables in
regard to possible changes due to the training intervention will be investigated. Collected
pilot data will be used for corresponding case number estimates of a subsequent confirmatory
study. The outcome variables are: number of back pain days and intensity, quality of life,
psychological well-being, work efficiency, days of sick-leave.
Study Design Randomized, investigator-blind, controlled pilot study with parallel group
comparison of outcomes in employees of the General Hospital of Vienna (AKH) over the age of
45 years
Study Subjects 2 x 30 employees over the age of 45, who suffered more than 30 days of back
and / or lower back pain of moderate to high intensity ≥ 3 (numeric scale 0-10) in the last
year and suffer from pain in up to 3 body parts (in total) or less. Group I starts with a
machine assisted training, group II starts after a period of observation half a year later.
Study Interventions 40 training sessions (2x / week) with DAVID training machines, which aim
to improve the strength, endurance and performance of the core trunk musculature. The
training will be initiated after a sufficiently long period of adjustment to the guidelines
of the American College of Sports Medicine. The training plan is created individually for
each subject. 4 to 6 people per hour can work out simultaneously. The training should be
completed in max 6 months or less.
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.
After 6 months the groups are switched (group I with the initial DAVID machine assisted
training is left with recommendations to "stay active"; subjects from group II are now
trained for 6 months by means of 40 training sessions (2x / week) with DAVID assistance),
thus, study subjects act as their own controls.
