Army Low Back Training Study

ISRCTN	ISRCTN19334317
DOI	https://doi.org/10.1186/ISRCTN19334317
Protocol serial number	N/A
Sponsor	Royal Netherlands Army (The Netherlands)
Funder	Dutch Ministry of Defence (The Netherlands)

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

P.O. Box 90004
Utrecht
3509 AA
Netherlands

Phone	+31 (0)30 2366605
Email	tgtf@army.dnet.mindef.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2008	11/06/2019	Yes	No
Protocol article	protocol	09/11/2004		Yes	No

Editorial Notes

11/06/2019: Publication reference and total final enrolment added.