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

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ClinicalTrials.gov Identifier: NCT03309540
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
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.
The EuroQol Research Foundation
This research is supported by the Fysio Science Institute® and is a non-profit institution.
Information provided by (Responsible Party):
Robbert van Amstel, Vrije Universiteit Brussel

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 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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Physiotherapy Quality of Life Range of Motion Pain Intensity Other: Physioterapy intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Level of evidence 1b, One way, RMANOVA, mixed, Pilot RCT, design
Masking: Single (Participant)
Masking Description: University of Brussels Medical expertise and rehabilitation center IJsselstein
Primary Purpose: Treatment
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.
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).

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®.


Sham Comparator: 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®.

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®.





Primary Outcome Measures :
  1. First measurment: Quality of life, EQ-5D-3L-index [ Time Frame: 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.


  2. Second measurment: Quality of life, EQ-5D-3L-index [ Time Frame: Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7) ]

    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.


  3. Third measurment: Quality of life, EQ-5D-3L-index [ Time Frame: Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7) ]

    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.


  4. Fourth measurment: Quality of life, EQ-5D-3L-index [ Time Frame: Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12) ]

    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.


  5. First measurment: EQ- visual analogue scale (VAS) [ Time Frame: Time Frame: 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.

  6. Second measurment: EQ- visual analogue scale (VAS) [ Time Frame: Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7) ]
    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.

  7. Third measurment: EQ- visual analogue scale (VAS) [ Time Frame: Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7) ]
    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.

  8. Fourth measurment: EQ- visual analogue scale (VAS) [ Time Frame: Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12) ]
    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.


Secondary Outcome Measures :
  1. AROM° thoracolumbar-pelvic flexion (TLPF) [ Time Frame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12) ]

    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.


  2. AROM° thoracolumbar- pelvic extension (TLPE) [ Time Frame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12) ]

    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.


  3. AROM° isolated lumbar flexion(ILF) [ Time Frame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12) ]

    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.


  4. Pain intensity flexion (0-10) [ Time Frame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12) ]

    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.


  5. Pain intensity extension (0-10) [ Time Frame: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12) ]

    . 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309540


Contacts
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Contact: Robbert R.N. Amstel, MSc 0611763830 ext +31 Robbert.Van.Amstel@vub.be
Contact: Peter P Vaes, PhD +322 477 43 26 ext +32 pvaes@vub.be

Locations
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Belgium
Peter Vaes Recruiting
Jette, Brussels, Belgium, 1090
Contact: Robbert R.N. van Amstel, MSc    0611763830 ext +31    Robbert.Van.Amstel@vub.be   
Sponsors and Collaborators
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.
The EuroQol Research Foundation
This research is supported by the Fysio Science Institute® and is a non-profit institution.
Investigators
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Study Director: Peter P Vaes, PhD University of Brussels, faculty of Rehabilitation science and physical therapy, faculty of Pharmacy and medicine, Brussels, Belgium

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Responsible Party: Robbert van Amstel, Master of science, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03309540     History of Changes
Other Study ID Numbers: EBP4MTOR02
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robbert van Amstel, Vrije Universiteit Brussel:
Low back/lumbar spine
Multimodal Physical therapy
Quality of life
Range of Motion
Pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms