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

11 de octubre de 2018 actualizado por: Robbert van Amstel, Vrije Universiteit Brussel

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.

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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Peter P Vaes, PhD
  • Número de teléfono: +32 +322 477 43 26
  • Correo electrónico: pvaes@vub.be

Ubicaciones de estudio

  • Bélgica
    • Brussels
      • Jette, Brussels, Bélgica, 1090
        • Reclutamiento
        • Peter Vaes
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 60 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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).
Otro: Intervención de fisioterapia

En el grupo experimental (EGR), se utilizará el método de tratamiento 4MTOR® para LBP. Este 4MTOR® utiliza los siguientes pasos en un árbol de decisión: Prueba T1 (examen fisioterapéutico), activación T2 (técnicas manuales), vendaje T3 (cinta elástica) y entrenamiento T4 (ejercicios de rehabilitación médica).

Los participantes en el SGR recibieron una intervención fisioterapéutica multimodal sham como intervención de control, en la que se aplicó la técnica Sham. Las intervenciones consistieron en combinar intervenciones manuales Sham, cintas elásticas según Kaze32 y Terapia de Práctica Basada en la Evidencia (Anexo III). El protocolo en el SGR sigue pasos similares: prueba, grabación, activación y entrenamiento como el 4MTOR®.
Comparador falso: 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®.
Otro: Intervención de fisioterapia

En el grupo experimental (EGR), se utilizará el método de tratamiento 4MTOR® para LBP. Este 4MTOR® utiliza los siguientes pasos en un árbol de decisión: Prueba T1 (examen fisioterapéutico), activación T2 (técnicas manuales), vendaje T3 (cinta elástica) y entrenamiento T4 (ejercicios de rehabilitación médica).

Los participantes en el SGR recibieron una intervención fisioterapéutica multimodal sham como intervención de control, en la que se aplicó la técnica Sham. Las intervenciones consistieron en combinar intervenciones manuales Sham, cintas elásticas según Kaze32 y Terapia de Práctica Basada en la Evidencia (Anexo III). El protocolo en el SGR sigue pasos similares: prueba, grabación, activación y entrenamiento como el 4MTOR®.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
First measurment: Quality of life, EQ-5D-3L-index
Periodo de tiempo: 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.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3)
Second measurment: Quality of life, EQ-5D-3L-index
Periodo de tiempo: 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.
Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
Third measurment: Quality of life, EQ-5D-3L-index
Periodo de tiempo: 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.
Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
Fourth measurment: Quality of life, EQ-5D-3L-index
Periodo de tiempo: 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.
Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)
First measurment: EQ- visual analogue scale (VAS)
Periodo de tiempo: 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.
Time Frame: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
Second measurment: EQ- visual analogue scale (VAS)
Periodo de tiempo: 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.
Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
Third measurment: EQ- visual analogue scale (VAS)
Periodo de tiempo: 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.
Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
Fourth measurment: EQ- visual analogue scale (VAS)
Periodo de tiempo: 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.
Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
AROM° thoracolumbar-pelvic flexion (TLPF)
Periodo de tiempo: 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.
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 (TLPE)
Periodo de tiempo: 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.
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(ILF)
Periodo de tiempo: 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.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
Pain intensity flexion (0-10)
Periodo de tiempo: 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.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
Pain intensity extension (0-10)
Periodo de tiempo: 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.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Vrije Universiteit Brussel

Colaboradores

The EuroQol Research Foundation
This research is supported by the Fysio Science Institute® and is a non-profit institution.
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.

Investigadores

  • Director de estudio: Peter P Vaes, PhD, University of Brussels, faculty of Rehabilitation science and physical therapy, faculty of Pharmacy and medicine, Brussels, Belgium

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de octubre de 2017

Finalización primaria (Anticipado)

31 de diciembre de 2018

Finalización del estudio (Anticipado)

31 de diciembre de 2018

Fechas de registro del estudio

Enviado por primera vez

2 de octubre de 2017

Primero enviado que cumplió con los criterios de control de calidad

12 de octubre de 2017

Publicado por primera vez (Actual)

13 de octubre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de octubre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

11 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • EBP4MTOR02

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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