|- candidate number||1177|
|- NTR Number||NTR102|
|- Date ISRCTN created||11-okt-2004|
|- date ISRCTN requested||18-aug-2005|
|- Date Registered NTR||4-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||Army Low Back Training Study.|
|- Scientific Title||A miminal intervention strategy for subacute and chronic non specific low back pain patients.|
|- hypothesis||Efficacy of minimal intervention strategy (isolated training of the lumbar extensors) with the use of a control group receiving usual care. |
|- Healt Condition(s) or Problem(s) studied||Low back pain (LBP), Non-specific|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||30-sep-2002|
|- planned closingdate||31-jul-2006|
|- Target number of participants||150|
|- Interventions||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).
|- 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.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Chris C. Harts|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. R.A. Bie, de|
|- Sponsor/Initiator ||Academic Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|- Publications||1. Arch Phys Med Rehabil. 2008 Sep;89(9):1675-85. |
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.
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.
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||4-aug-2005 - 2-dec-2008|