No registrations found.
ID
Source
Brief title
Health condition
Subacute and chronic nonspecific low back pain.
Sponsors and support
address: see above
Intervention
Outcome measures
Primary outcome
1. Global Perceived Effect;
2. Patient Specific Functional Status;
3. Low-back specific functional status (RDQ).
Secondary outcome
1. Tampa Scale for Kinesiophobia;
2. General Helath Qeuestionnaire;
3. Work and Social status;
4. Patient satisfaction;
5. Isometric strength of lumbar extensors.
Background summary
Although a substantial number of trials have been conducted that included lumbar extension training in low back pain patients, hardly any study has emphasized a minimal intervention approach comparable to ours.
Currently, a randomized controlled trial is carried out in six military health centers in The Netherlands and Germany, in which a 10-week program of not more than 2 training sessions (10-15 minutes) per week is studied in soldiers with nonspecific low back pain for more than 4 weeks. The purpose of the study is to investigate the efficacy of this 'minimal intervention program', compared to usual care. Moreover, attempts are made to identify subgroups of different responders to the intervention.
Besides, a baseline measurement, follow-up data are gathered at two short-term intervals (5 and 10 weeks after randomization) and two long-term intervals (6 months and one year after the end of the intervention), respectively.
Inclusion will end in July 2005.
Study objective
Efficacy of minimal intervention strategy (isolated training of the lumbar extensors) with the use of a control group receiving usual care.
Study design
N/A
Intervention
1. Isolated training of the lumbar extensors muscles on a training device in a 10-week progressive resistance training program;
2. Usual care including hands-on treatment (manual therapy) and/or hands-off treatment (excercise therapy without isolated lumbar extensor training and education).
P.O. Box 90004
Chris C. Harts
Utrecht 3509 AA
The Netherlands
+31 (0)30 2366416
tgtf@army.dnet.mindef.nl
P.O. Box 90004
Chris C. Harts
Utrecht 3509 AA
The Netherlands
+31 (0)30 2366416
tgtf@army.dnet.mindef.nl
Inclusion criteria
1. Royal Netherlands Army militairy personnel aged between 18 and 55;
2. Non specific low back pain for at least 4 weeks;
3. Availabibity for treatment during (at least) 8 weeks.
Exclusion criteria
1. Specific LBP (fractures, tumors, herniated disc or other relevant neurologic diseases;
2. Treatment during the last month;
3. Spinal surgery in the past 2 years;
4. Disability to perform an isometric strength test of the lumbar extensor muscles.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL71 |
| NTR-old | NTR102 |
| Other | : N/A |
| ISRCTN | ISRCTN19334317 |
Summary results
2. Comparison of a high-intensity and a low-intensity lumbar extensor training program as minimal intervention treatment in low back pain: a randomized trial. Helmhout et al. Eur Spine J. 2004 Oct;13(6):537-47.<br>
3. Rationale and design of a multicenter randomized controlled trial on a 'minimal intervention' in Dutch army personnel with non-specific low back pain. Helmhout et al. BMC Musculoskelet Disord. 2004 Nov 9;5(1):40.