Army Low Back Training Study
| ISRCTN | ISRCTN19334317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19334317 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/09/2004
- Registration date
- 11/10/2004
- Last edited
- 11/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Pieter Herman Helmhout
Scientific
Scientific
P.O. Box 90004
Utrecht
3509 AA
Netherlands
| Phone | +31 (0)30 2366605 |
|---|---|
| tgtf@army.dnet.mindef.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Army Low Back Training Study |
| Study acronym | ALBATRoS |
| Study objectives | To evaluate the efficacy of progressive, isolated resistance training of the lumbar extensor muscles, compared to the usual care. |
| Ethics approval(s) | Ethics approval received from the Medical Ethics Committee of the Netherlands Central Military Hospital. |
| Health condition(s) or problem(s) studied | Aspecific low back pain |
| Intervention | Specific strengthening of the lumbar extensor muscles versus usual care for aspecific low back pain. |
| Intervention type | Other |
| Primary outcome measure | 1. Global perceived effect, measured by self-assessment on a 7-point scale 2. Patient-specific functional status, measured by a questionnaire following a patient-specific approach 3. Low-back specific functional status, measured by the validated Dutch version of the Roland Disability Questionnaire Beside a baseline measurement, follow-up data are gathered at two short-term intervals and two long-term intervals. Short-term follow-up measurements are at 5 and 10 weeks after randomisation. Long-term follow-up measurements are at 6 months and one year after the end of the intervention, respectively. |
| Secondary outcome measures | 1. Fear of movement or re-injury, measured by the Tampa Scale for Kinesiophobia 2. Mental health, measured by the Dutch translation of the 12-item General Health Questionnaire 3. Social health, measured by a subscale of the Impact on Participation and Autonomy Questionnaire 4. Overall work status 5. Individual back extension strength progression 6. Patient satisfaction, measured at the end of the treatment program Beside a baseline measurement, follow-up data are gathered at two short-term intervals and two long-term intervals. Short-term follow-up measurements are at 5 and 10 weeks after randomisation. Long-term follow-up measurements are at 6 months and one year after the end of the intervention, respectively. |
| Overall study start date | 01/04/2002 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Total final enrolment | 129 |
| Key inclusion criteria | 1. Military employees of the RNLA between the age of 18 and 54 years 2. At least 4 weeks of continuous or recurrent (at least three times a week) episodes of low back pain (LBP) pain localised 3. Between posterior iliac crests and angulus inferior scapulae 4. Availability to visit the local military health centre two times a week during 10 consecutive weeks 5. No more than two sessions of absence due to job-related activities (e.g. military exercise, course, leave) 6. Willingness to abandon other treatment interventions for the lower back during the intervention period 7. Signed informed consent |
| Key exclusion criteria | 1. Spinal surgery in the last 2 years 2. Specific treatment for LBP in the last 4 weeks (e.g. physiotherapy, manual therapy) 3. Severe LBP which hinders in performing maximal isometric strength efforts 4. Specific LBP, defined as herniated disc, ankylosing spondylitis, spondylolisthesis 5. Neurological diseases |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Germany
- Netherlands
Study participating centre
P.O. Box 90004
Utrecht
3509 AA
Netherlands
3509 AA
Netherlands
Sponsor information
Royal Netherlands Army (The Netherlands)
Government
Government
Occupational Health and Safety Service
P.O. Box 90004
Utrecht
3509 AA
Netherlands
Funders
Funder type
Government
Dutch Ministry of Defence (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/11/2004 | Yes | No | |
| Results article | results | 01/09/2008 | 11/06/2019 | Yes | No |
Editorial Notes
11/06/2019: Publication reference and total final enrolment added.
