Quality of Life Clinical Trial
Official title:
Effects of a Multimodal Intervention Based on the 4 Times T Orthopedic Rehabilitation Decision Tree on the Quality of Life in Non-specific Chronic Low Back Pain.
The purpose of this study is to investigate the effect on QoL, PI and the AROM° in patients with non-specific chronic low back pain. This after following an episode of 6 weeks 2 times a week physiotherapeutic back rehabilitation according to the 4 times T method by orthopaedic disorder ® (4MTOR®). The results in this research will be analyzed and reported. In this study, 7 dependent variables will be independently examined relative to 2 independent variables.
The purpose of this small RCT is to investigate whether this is a good research design and
procedure to measure the effect on QoL, PI and the AROM° in patients with NSP-CLBP. This
after following an episode of 6 weeks twice a week physiotherapeutic back rehabilitation
according to the 4MTOR®. The results in this research will also be analysed and reported. The
research design and procedure will be useful when this small RCT shows that the 4MTOR® can
positively influence the QoL,PI and the AROM° with a p value <α = 0.05 in NSP-CLBP patients.
Primary variable is the QoL these are measured using the EQ-5D-3L which consists of the
EQ-5D-index and the EQ visual analogue scale (EQ-VAS). The EQ-5D-3L questionnaire is
developed by Euroqol Group. Secondary outcome measures are the AROM° of the active trunk
flexion and trunk extension measured with a bubble inclinometer. Also, the PI will be scored
by the patient during flexion and extension by means of the Verbal Pain Scale scaled 0-10
(VRS). The outcomes will be measured within 12 weeks in all participants. The measurements
take place during week 0 the baseline measurement (W0), week 3 the intermediate measurement
(W3) week 7 the post measurement (W7) and finally week 12 follow up measurement (W12). All
participants were fully 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.
Inclusion and exclusion criteria. Participants are included when they meet the following
criteria: NSP-CLBP from 12 weeks and longer that are continuously present (with and without
recurrent complaints), Age between 20 and 60 years and not yet treated by the 4MTOR®.
Participants are excluded when they meet the following criteria: Radiological disturbing pain
beyond knee, extremely serious 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 are recruited from orthopedic hospitals
departments in Utrecht the Netherlands. Participants will be asked if they want to refer
NSP-CLBP patients for this research and by advertisement in an Dutch-language newspaper
(Appendix II). Also, NSP-CLBP patients who applied for physical therapy were asked if they
wanted to participate in this research. A call form has been prepared for this purpose
(Appendix III). All subjects were asked if they would like to participate in this research.
The subjects has been authorized to perform medical physiotherapeutic treatment. This has
been done 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 Health Care registered physiotherapist
and has at least 3 years work experience and is familiar with the KNGF Low Back pain, 2013
guidelines (KNGF_LBP). Both therapists were informed about their work protocol and have
agreed to the implementation of the interventions by signing an informed consent.
In the experimental group (EGR), the 4MTOR® treatment method will be used for LBP. This
4MTOR® uses the following steps in a decision tree: T1 Testing (Physiotherapeutic
examination), T2 Triggering (Manual Techniques), T3 Taping (Elastic Tape) and T4 Training
(medical rehabilitation exercises).
The participants in the Sham group (SGR) received a sham multimodal physiotherapeutic
intervention as control intervention, in which Sham technique was applied. The interventions
consisted of combining Sham manual interventions, elastic tapes according to Kaze32 and
Evidence Based Practice Therapy (Appendix III). The protocol in the SGR follows the similar
steps: Testing, Taping, Triggering and Training like the 4MTOR®.
Primary:
- EQ 5d-5L questionnaire
Secondary:
Thoracolumbo-pelvic flexion, inclinometry Thoracolumbo-pelvic extension, inclinometry (note 5
x for measurement errors) Isolated lumbar flexion, inclinometry Verbal pain score flexion,
VRS 0-10 Verbal pain score extension, VRS 0-10
Research design. This research is a one way, Mixed, real experimental design One way design
(Independent Groups variables). Mixed Design: Baseline Week 0 - Week 3 - Week 7-Week 12
Within groups: difference in time Between groups: difference between groups.
The sample analysis was performed for the RM-ANOVA using the Gpower © program. The RM-ANOVA
power analysis with the following values: Power .95, Alpha 0.50, Sample size effect f2 = .24
resulted in a minimum of 40 participants. 20% will be added on the total N=48 for the
possibility of dropouts. The CLBP participants are divided into two groups, each group
holding twenty-five participants.
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