Contact information
Type
Scientific
Primary contact
Mr Pieter Herman Helmhout
ORCID ID
Contact details
P.O. Box 90004
Utrecht
3509 AA
Netherlands
+31 (0)30 2366605
tgtf@army.dnet.mindef.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ALBATRoS
Study hypothesis
To evaluate the efficacy of progressive, isolated resistance training of the lumbar extensor muscles, compared to the usual care.
Ethics approval
Ethics approval received from the Medical Ethics Committee of the Netherlands Central Military Hospital.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Aspecific low back pain
Intervention
Specific strengthening of the lumbar extensor muscles versus usual care for aspecific low back pain.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2002
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
01/04/2002
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Germany, Netherlands
Trial participating centre
P.O. Box 90004
Utrecht
3509 AA
Netherlands
Funders
Funder type
Government
Funder name
Dutch Ministry of Defence (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15535881
Publication citations
-
Protocol
Helmhout PH, Harts CC, Staal JB, de Bie RA, Rationale and design of a multicenter randomized controlled trial on a 'minimal intervention' in Dutch army personnel with nonspecific low back pain [ISRCTN19334317]., BMC Musculoskelet Disord, 2004, 5, 1, 40, doi: 10.1186/1471-2474-5-40.