Effect of Physiotherapeutic Interventions on Quality of Life in Patients With Chronic Low Back Pain. (Study 1)
Condition: Physical Therapy; Chronic Low Back Pain; Quality of Life; Range of Motion; Pain Intensity
MeSH terms: Back Pain; Low Back Pain; Pain
Study type: Interventional

Summary: 
      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 orthopedic
      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.
    

Detailed description: 
      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 7 weeks in all participants. The measurements
      take 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 fully informed for
      the research and agreed by signing the "informed consent" (Appendix Ia). 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)74. 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 were 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
      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 Within
      groups: difference in time Between groups: difference between groups.

      The RMANOVA-MD power analysis was performed using the following values: Power.81, Alpha 0.50,
      Sample size effect f2 =.25, resulting in a minimum of 28 participants, Fcritical = 3.175 and
      an actual power of .82 . Cohen advises a medium-sized effect size (f2 = .25) in a RMANOVA-MD.
      10% will be added to these 28 participants (n = 30), towards the possible dropouts. The
      NSP-CLBP participants are divided into 2 groups.
    

Intervention name(s): Physioterapy intervention
Intervention type(s): Other
Intervention description(s): 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 SGR received a sham multimodal physiotherapeutic intervention as control intervention, in which Sham technique were 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®.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: One way, mixed, Randomized Controlled Trial(RCT), intention to threat design, level 2b.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low back/lumbar spine; Multimodal Physical therapy; Quality of life; Range of Motion; Pain