Effect of Physiotherapeutic Interventions on Quality of Life in Patients With Chronic Low Back Pain. (Study 2) (CLBP)
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Robbert R.N. Amstel, MSc
- 电话号码：+31 0611763830
- 邮箱：Robbert.Van.Amstel@vub.be
研究联系人备份
- 姓名：Peter P Vaes, PhD
- 电话号码：+32 +322 477 43 26
- 邮箱：pvaes@vub.be
学习地点
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Brussels
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Jette、Brussels、比利时、1090
- 招聘中
- Peter Vaes
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接触：
- Robbert R.N. van Amstel, MSc
- 电话号码：+31 0611763830
- 邮箱：Robbert.Van.Amstel@vub.be
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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). |
在实验组 (EGR) 中，4MTOR® 治疗方法将用于 LBP。 此 4MTOR® 在决策树中使用以下步骤：T1 测试（物理治疗检查）、T2 触发（手动技术）、T3 贴扎（弹性胶带）和 T4 训练（医疗康复练习）。 SGR 的参与者接受了假的多模式物理治疗干预作为对照干预，其中应用了假技术。 干预措施包括结合模拟人工干预、根据 Kaze32 和循证实践疗法（附录 III）使用橡皮筋。 SGR 中的协议遵循类似的步骤：与 4MTOR® 类似的测试、录音、触发和培训。 |
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假比较器：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®. |
在实验组 (EGR) 中，4MTOR® 治疗方法将用于 LBP。 此 4MTOR® 在决策树中使用以下步骤：T1 测试（物理治疗检查）、T2 触发（手动技术）、T3 贴扎（弹性胶带）和 T4 训练（医疗康复练习）。 SGR 的参与者接受了假的多模式物理治疗干预作为对照干预，其中应用了假技术。 干预措施包括结合模拟人工干预、根据 Kaze32 和循证实践疗法（附录 III）使用橡皮筋。 SGR 中的协议遵循类似的步骤：与 4MTOR® 类似的测试、录音、触发和培训。 |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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First measurment: Quality of life, EQ-5D-3L-index
大体时间：Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3)
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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. |
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3)
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Second measurment: Quality of life, EQ-5D-3L-index
大体时间：Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
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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. |
Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
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Third measurment: Quality of life, EQ-5D-3L-index
大体时间：Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
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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-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table. |
Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
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Fourth measurment: Quality of life, EQ-5D-3L-index
大体时间：Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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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: W7-W12 Between groups: EGR versus SGR. The results are shown for all variables in a table. |
Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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First measurment: EQ- visual analogue scale (VAS)
大体时间：Time Frame: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
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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.
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Time Frame: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
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Second measurment: EQ- visual analogue scale (VAS)
大体时间：Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
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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.
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Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
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Third measurment: EQ- visual analogue scale (VAS)
大体时间：Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
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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-W7 Between groups: EGR versus SGR.
The results are shown for all variables in a table.
|
Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
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Fourth measurment: EQ- visual analogue scale (VAS)
大体时间：Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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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: W7-W12 Between groups: EGR versus SGR.
The results are shown for all variables in a table.
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Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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AROM° thoracolumbar-pelvic flexion (TLPF)
大体时间：Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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AROM° Thoracolumbar-pelvic flexion. The inclinometer placed on L1 / T12 with the tape between the inclinometer arcus and was set to 0°. During the test, the investigator kept the inclinometer on L1 / T12 while instructing the subject to bend forward with the arms in hanging position. The changes in our variables will be analyzed within time and between groups. Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05. |
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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AROM° thoracolumbar- pelvic extension (TLPE)
大体时间：Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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AROM° Thoracolumbar-pelvic extension. The inclinometer placed on L1 / T12 with the tape between the inclinometer arcus and was set to 0 °. During the test, the investigator kept the inclinometer on L1 / T12 while instructing the subject to put his hands on his pelvis and bend backward. The changes in our variables will be analyzed within time and between groups. Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05. |
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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AROM° isolated lumbar flexion(ILF)
大体时间：Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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AROM° Isolated lumbar flexion test. The inclinometer was moved to labeled S1 / S2 and the inclinometer was set to 0 °. During the test, the investigator held the inclinometer on S1 / S2 while instructing the subject to bend forward. The formula ∑▒〖T12/L1〗 - S1/S2 was used. The changes in our variables will be analyzed within time and between groups. Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05. |
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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Pain intensity flexion (0-10)
大体时间：Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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Before the participant gave a PI number to the active flexion or extension, the VRS scale was shown. Thereafter the movement was performed as described in the protocol. After completing the active flexion or extension, the participant gave a VRS score regarding the PI. The changes in our variables will be analyzed within time and between groups. Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05. |
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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Pain intensity extension (0-10)
大体时间：Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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. Before the participant gave a PI number to the active flexion or extension, the VRS scale was shown. Thereafter the movement was performed as described in the protocol. After completing the active flexion or extension, the participant gave a VRS score regarding the PI. The changes in our variables will be analyzed within time and between groups. Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05. |
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
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合作者和调查者
合作者
调查人员
- 研究主任：Peter P Vaes, PhD、University of Brussels, faculty of Rehabilitation science and physical therapy, faculty of Pharmacy and medicine, Brussels, Belgium
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
生活质量的临床试验
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Swansea University完全的
-
Yale-NUS College完全的
-
Scripps Translational Science Institute完全的
物理治疗干预的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人