Clinical trial NCT03322956: Effect of Physiotherapeutic Interventions on Quality of Life in Patients With Chronic Low Back Pain. (Study 1)
Official title: The Measurable Impact of a Protocoled Multimodal Physiotherapeutic Intervention on the Quality of Life in Patients With Non- Specific Chronic Low Back Pain. A Small RCT Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Chronic Low Back Pain
Quality of Life
Range of Motion
Pain Intensity
Keywords: Low back/lumbar spine
Multimodal Physical therapy
Quality of life
Range of Motion
Pain
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Approved by the Committee of Medical Ethics University Hospital University of Brussels, B.U.N. 143201627110.
name: Insurance on experiment on human subjects by ethias liability policy: 45.147.458
name: The EuroQol Research Foundation
name: This research is supported by the Fysio Science Institute® and is a non-profit institution.
First posted: 2017-10-26
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: One way, mixed, Randomized Controlled Trial(RCT), intention to threat design, level 2b.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion 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
* Not yet treated by the 4MTOR®.

Exclusion Criteria:

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
* Severe deformity of the spinal cord

Primary outcomes:
measure: First measurment: Quality of life, EQ-5D-3L-index
timeFrame: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
measure: Second measurment: Quality of life, EQ-5D-3L-index
timeFrame: Timespad registration: Week 3/intermediate measurement (W3) - Week 7 post measurment
measure: Third measurment: Quality of life, EQ-5D-3L-index
timeFrame: Timespad registration: Week 0/baseline measurement (W0)- Week 7 post measurment
measure: First measurment: EQ- visual analogue scale (VAS)
timeFrame: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
measure: Second measurment: EQ- visual analogue scale (VAS)
timeFrame: Timespad registration: Week 3/intermediate measurement (W3) - Week 7 post measurment
measure: Third measurment: EQ- visual analogue scale (VAS)
timeFrame: Timespad registration: Week 0/baseline measurement (W0)- Week 7 post measurment
Secondary outcomes:
measure: AROM° thoracolumbar-pelvic flexion (TLPF)
timeFrame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).
measure: AROM° thoracolumbar- pelvic extension (TLPE)
timeFrame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).
measure: AROM° isolated lumbar flexion(ILF)
timeFrame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).
measure: Pain intensity extension (0-10)
timeFrame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).
measure: Pain intensity flexion (0-10)
timeFrame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Peter Vaes
state: Brussels
Study officials:
affiliation: University of Brussels, faculty of Rehabilitation science and physical therapy, faculty of Pharmacy and medicine, Brussels, Belgium
name: Peter P. Vaes, PhD
role: STUDY_DIRECTOR
References: