Condition category
Musculoskeletal Diseases
Date applied
02/09/2004
Date assigned
11/10/2004
Last edited
12/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Royal Netherlands Army (The Netherlands)

Sponsor details

Occupational Health and Safety Service
P.O. Box 90004
Utrecht
3509 AA
Netherlands

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes