|
ISRCTN
|
ISRCTN19334317
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Army Low Back Training Study
|
|
Scientific title
|
|
|
Acronym
|
ALBATRoS
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
To evaluate the efficacy of progressive, isolated resistance training of the lumbar extensor muscles, compared to the usual care.
|
|
Lay summary
|
|
|
Ethics approval
|
Ethics approval received from the Medical Ethics Committee of the Netherlands Central Military Hospital.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Germany, Netherlands
|
|
Disease/condition/study domain
|
Aspecific low back pain
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/04/2002
|
|
Anticipated end date
|
31/12/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Specific strengthening of the lumbar extensor muscles versus usual care for aspecific low back pain.
|
|
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.
|
|
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.
|
|
Sources of funding
|
Dutch Ministry of Defence (The Netherlands)
|
|
Trial website
|
|
|
Publications
|
Protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15535881
|
|
Contact name
|
Mr
Pieter Herman
Helmhout
|
|
Address
|
P.O. Box 90004
|
|
City/town
|
Utrecht
|
|
Zip/Postcode
|
3509 AA
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)30 2366605
|
|
Fax
|
+31 (0)30 2366412
|
|
Email
|
tgtf@army.dnet.mindef.nl
|
|
Sponsor
|
Royal Netherlands Army (The Netherlands)
|
|
Address
|
Occupational Health and Safety Service
P.O. Box 90004
|
|
City/town
|
Utrecht
|
|
Zip/Postcode
|
3509 AA
|
|
Country
|
Netherlands
|
|
Date applied
|
02/09/2004
|
|
Last edited
|
12/08/2008
|
|
Date ISRCTN assigned
|
11/10/2004
|
