Effect of Physiotherapeutic Interventions on Quality of Life in Patients With Chronic Low Back Pain. (Study 2)

Quality of Life Clinical Trial

— CLBP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03309540
• Other study ID #: EBP4MTOR02
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2018
• Source: Vrije Universiteit Brussel
• Contact: Robbert R.N. Amstel, MSc
• Phone: 0611763830
• Email: Robbert.Van.Amstel[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Pain
• Pain Intensity
• Physiotherapy
• Quality of Life
• Range of Motion

Intervention

Other:
• Physioterapy 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). 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®.

Locations

Country	Name	City	State
Belgium	Peter Vaes	Jette	Brussels

Sponsors (5)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Committee of Medical Ethics University Hospital University of Brussels, B.U.N. 143201627110., Ethias liability policy: 45.147.458, insurance for the experiment on human subjects., EuroQol Research Foundation's registration for using the questionnaire EQ5D3L, This research is supported by the Fysio Science Institute® and is a non-profit institution.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First measurment: Quality of life, EQ-5D-3L-index	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 pWithin 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)
Primary	Second measurment: Quality of life, EQ-5D-3L-index	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 pWithin 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)
Primary	Third measurment: Quality of life, EQ-5D-3L-index	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 pWithin 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)
Primary	Fourth measurment: Quality of life, EQ-5D-3L-index	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 pWithin 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)
Primary	First measurment: EQ- visual analogue scale (VAS)	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	Time Frame: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
Primary	Second measurment: EQ- visual analogue scale (VAS)	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	Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
Primary	Third measurment: EQ- visual analogue scale (VAS)	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	Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
Primary	Fourth measurment: EQ- visual analogue scale (VAS)	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	Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)
Secondary	AROM° thoracolumbar-pelvic flexion (TLPF)	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	Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
Secondary	AROM° thoracolumbar- pelvic extension (TLPE)	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	Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
Secondary	AROM° isolated lumbar flexion(ILF)	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	Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
Secondary	Pain intensity flexion (0-10)	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	Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
Secondary	Pain intensity extension (0-10)	. 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	Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)