Back PainNCT03393429
Training Therapy for the Prevention of Back Pain
A study testing DAVID assisted training and training recommendation in people with Back Pain and Lower Back Pain, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Back Pain, Lower Back Pain
- What is being tested?
- DAVID assisted training and training recommendation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2017to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects must have suffered from (low) back pain for at least 6 days in the last month, without treatment by a doctor or feeling in need of treatment.
- subject reported pain should reach the level of 3 or more on the numeric rating scale of 0-10 (0 equals no pain and 10 represents the strongest imaginable pain) [Larsen et al, 2008; Blagsted et al., 2008].
- protocol documenting pain and work disability/limitations daily for a month must be completed
- written consent after completed patient education by a physician must be given
Who cannot join
- in order to rule out generalized musculoskeletal disorders, subjects should report discomfort or pain in no more than 3 different body parts
- arterial hypertension and cardiovascular events such as myocardial infarction within the last year and / or cardiomyopathy NYHA III and IV.
- symptomatic, lumbar disc herniation with associated neurological deficits
- specific spinal diseases as potential underlying reason for a back pain syndrome including rheumatoid arthritis, ankylosing spondylitis, manifested osteoporosis with St.p. vertebral fractures, tumors.
- St.p. traumatic damage of spine, pelvis or femur in the last 6 months
- insufficiently healed surgical wounds in any body area
Show all 13Show fewer
- imminent musculoskeletal, spinal, hip or knee surgery
- chronic infectious diseases
- diagnosed mental illness
- previous severe trauma with permanent Musculoskeletal dysfunction
- pregnancy prior to study entrance examination
- no written consent to the study
- less than 1 year before retirement or planned job change within one year
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Department of Physical Medicine, Rehabilitation and Occupational Medicine
Vienna, 1090
About this study
Official title: Training Therapy for the Secondary and Tertiary Prevention of Backache and Low Back Pain: A Randomized Controlled Pilot Study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Back Pain, Lower Back Pain
- Being tested
- DAVID assisted training, training recommendation
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAVID assisted trainingOther
DAVID device assisted training under supervision
training recommendationOther
training recommendation to "stay active"
| Study group | Role | What they receive |
|---|---|---|
| DAVID assisted training | Active comparator | Group I: Training assisted by DAVID devices Receives: Other: DAVID assisted training |
| training recommendation | Placebo comparator | Group II: Training based on "stay active" recommendations Receives: Other: training recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Frequency
Incidence of pain-days and pain-intensity
Measured: 6 months
Secondary outcomes (1)
Sick-Leave
Days of sick-leave in total
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Nov 2017
- Primary completion1 Nov 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Gerold Ebenbichler, Medical University of Vienna
- Investigators
- Gerold Ebenbichler, Prof. Dr., Principal investigator, University Department of Physical Medicine, Rehabilitation and Occupational Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393429
- Sponsor's protocol ID
- 1118/2012
- Status last verified
- Oct 2020
- First submitted
- 3 Jan 2018
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Therapy for the Secondary and Tertiary Prevention of Backache and Low Back Pain: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03393429
- Acronym / sponsor ID
- 1118/2012
- Conditions
- Back Pain, Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAVID assisted training | Active comparator | Other: DAVID assisted trainingGroup I: Training assisted by DAVID devices |
| training recommendation | Placebo comparator | Other: training recommendationGroup II: Training based on "stay active" recommendations |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects must have suffered from (low) back pain for at least 6 days in the last month, without treatment by a doctor or feeling in need of treatment.
- subject reported pain should reach the level of 3 or more on the numeric rating scale of 0-10 (0 equals no pain and 10 represents the strongest imaginable pain) [Larsen et al, 2008; Blagsted et al., 2008].
- protocol documenting pain and work disability/limitations daily for a month must be completed
- written consent after completed patient education by a physician must be given
Key exclusion criteria (13 listed)
- in order to rule out generalized musculoskeletal disorders, subjects should report discomfort or pain in no more than 3 different body parts
- arterial hypertension and cardiovascular events such as myocardial infarction within the last year and / or cardiomyopathy NYHA III and IV.
- symptomatic, lumbar disc herniation with associated neurological deficits
- specific spinal diseases as potential underlying reason for a back pain syndrome including rheumatoid arthritis, ankylosing spondylitis, manifested osteoporosis with St.p. vertebral fractures, tumors.
- St.p. traumatic damage of spine, pelvis or femur in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAVID assisted trainingDAVID device assisted training under supervision | Other | DAVID assisted training |
| training recommendationtraining recommendation to "stay active" | Other | training recommendation |
Primary outcome
Pain Frequency
Time frame: 6 months
Incidence of pain-days and pain-intensity
1 secondary outcome
Sick-Leave
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
Related trials for Back Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerold Ebenbichler, Prof. Dr. principal investigator
University Department of Physical Medicine, Rehabilitation and Occupational Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAVID assisted training and training recommendation in people with Back Pain and Lower Back Pain, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Frequency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.