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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Third measurment: EQ- visual analogue scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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®.
排除标准
- •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
研究组 & 干预措施
experimental group (EGR)
Physical therapy intervention.
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).
干预措施: Physioterapy intervention (Other)
Sham group (SGR)
Physical therapy intervention.
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 Kaze and Evidence Based Practice Therapy. The protocol in the SGR follows the similar steps: Testing, Taping, Triggering and Training like the 4MTOR®.
干预措施: Physioterapy intervention (Other)
结局指标
主要结局
Third measurment: EQ- visual analogue scale (VAS)
时间窗: Timespad registration: Week 0/baseline measurement (W0)- Week 7 post measurment
The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p\<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W0-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.
First measurment: Quality of life, EQ-5D-3L-index
时间窗: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort \& anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p\<α=0.05. Within time: W0-W3 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Second measurment: Quality of life, EQ-5D-3L-index
时间窗: Timespad registration: Week 3/intermediate measurement (W3) - Week 7 post measurment
The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort \& anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p\<α=0.05.. Within time: W3-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Second measurment: EQ- visual analogue scale (VAS)
时间窗: Timespad registration: Week 3/intermediate measurement (W3) - Week 7 post measurment
The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p\<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W3-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Third measurment: Quality of life, EQ-5D-3L-index
时间窗: Timespad registration: Week 0/baseline measurement (W0)- Week 7 post measurment
The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort \& anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p\<α=0.05. Within time: W3-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.
First measurment: EQ- visual analogue scale (VAS)
时间窗: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p\<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W0-W3 Between groups: EGR versus SGR. The results are shown for all variables in a table.
次要结局
- AROM° thoracolumbar- pelvic extension (TLPE)(Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).)
- AROM° isolated lumbar flexion(ILF)(Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).)
- Pain intensity flexion (0-10)(Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).)
- Pain intensity extension (0-10)(Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).)
- AROM° thoracolumbar-pelvic flexion (TLPF)(Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3) and week 7/ post measurement (W7).)
研究者
Robbert van Amstel
Physical therapist, Master of science and manual therapist student
Vrije Universiteit Brussel