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The measurable impact of a protocoled multimodal physiotherapeutic intervention on the quality of life in patients with non-specific chronic low back pain. A RCT study

Introduction chronic low back pain Low back pain (LBP) is a common back complaint and is 8th in the ranking of Disability Adjusted Life Years (DALYs) [36]. In 2015, The Netherlands estimates, 1,982,300 people with diagnosis of neck and back complaints: 832,700 men and 1,149,600 women [37]. The RIVM reports that low back pain (LBP) is most common in musculoskeletal disorder, with a prevalence rate of 43.9% and a point of prevalence 26,9%, 21.2% of the LBP were chronic low back complaints [37]. Over 80% of low back pain is constantly present or consists of recurrent pain. Apparently, according to this report, 20.8% of adults have chronic low back pain [65]. Mobility of the spine is expressed in Range of Motion (ROM), which is measured during active trunk flexion and extension. The cause of LBP in non-specific chronic low back pain (NSP-CLBP) patients is unknown. Systematic review shows that the lumbar ROM is reduced in patients with low back pain [42]. However, a considerable variability was measured, this may be possible by using different measuring instruments, measurement method and margin of error, but also because LBP can come without ROM reduction [76]. The reduced ROM may adversely affect quality of life (QoL) [31]. We speak of chronicity if this statement is exclusively based on the duration of symptoms of low back pain. Continuous LBP episodes longer than 12 weeks called CLBP [37]. The first episode of low back pain usually occur in people between the age of 22 and 55 years. The LBP can be classified by duration; acute (0-6 weeks), subacute (7-12 weeks) and chronic (12> weeks) [73]. Several studies have investigated the effect of using a multimodal physiotherapeutic intervention the QoL, pain intensity (PI) and active ROM (AROM) in NSP-CLBP patients [20-22,24,40,59,81]. From these studies, it is apparent that the use of a multimodal physiotherapeutic approach combining various physiotherapeutic interventions in NSP-CLBP patients can positively affect the QoL, PI and ROM. The organized multimodal intervention according to the 4 x T method at orthopaedic rehabilitation® (4MTOR®), is a decision tree as main goal to guide the therapist in choosing the best possible intervention and the right location, direction and intensity of the selected intervention. 4MTOR® has not been investigated before. This study will compare the 4MTOR®to a exercise program with sham application on the Qol, PI and AROM in NSP-CLBP. Methods Research design Objective This study investigated the impact of the physiotherapeutic back rehabilitation care according to the 4MTOR® on NSPCLBP patients. We measured the QoL, PI and the AROM, after a period of 6 weeks twice a week physical therapy. The results in this research were analysed and reported. We hypothesized that the 4MTOR® can positively influence the QoL, PI and the AROM in NSP-CLBP patients. An statistically significant effect was found when a p value < α=0.05 was achieved [75].Primary variable was the QoL, this was measured by using
the EQ-5D-3L consisting of an EQ-5D-index and an EQ visual
analogue scale (EQ-VAS). The EQ-5D-3L questionnaire was
developed by Euroqol Group. Secondary outcome measures
were the AROM of the active trunk flexion and trunk extension
measured with a bubble inclinometer. Also, the PI was scored
by the patient during active flexion and extension by means of
the Verbal Rating Scale scaled 0-10 (VRS). The measurements
took place during week 0 the baseline measurement (W0),
week 3 the intermediate measurement (W3) and finally week
7 the post measurement (W7). All participants were informed
for the research and agreed by signing the “informed consent”
The research was approved by the Committee of Medical Ethics
University Hospital University of Brussels, B.U.N. 143201627110.
Participants
Inclusion and exclusion criteria
Participants were included when they met the following
criteria: NSP-CLBP from 12 weeks and longer, continuously
present (with and without recurrent complaints), Age between
20 and 60 years, untreated with 4MTOR®.
Participants were excluded when they met the following
criteria: Radiating disturbing pain beyond the knee, neurological disorder symptoms, overall malaise, spinal cord malignancy, unexplained weight loss, prolonged corticosteroid
use, osteoporotic vertebral fracture, spondylitis ankylopoetics,
spinal stenosis, rheumatic arthritis, vertebral fracture and
severe deformity of the spinal cord.
Recruitment
Patients recruitment
The subjects were recruited from orthopaedic hospitals
departments in Utrecht the Netherlands. Participants were
asked to refer NSP-CLBP patients for this research and by advertisement in an Dutch-language newspaper. Also, NSP-CLBP
patients, who applied for physical therapy, were required
to participate in this research. A call form was prepared for
this purpose. All subjects were asked if they would like to
participate in this research. The subjects were authorized to
perform medical physiotherapeutic treatment by signing a
statement of agreement, as previously stated. Personal data
will not be included in this research and are protected by
researchers and the Committee of Medical Ethics University
Hospital University of Brussels.
Therapist recruitment Experimental intervention group
This physiotherapist has been educated and qualified in the
KNGF accredited multimodal intervention according to the
4MTOR®. The physiotherapist has at least 2 years of work
experience with the use of the 4MTOR® decision tree.
Therapist recruitment SHAM intervention group
This is a Health Care registered physiotherapist and has at least
3 years work experience and is familiar with the KNGF Low

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