Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?
28 de marzo de 2022 actualizado por: Saurab Sharma, Kathmandu University School of Medical Sciences
Effectiveness of TENS and Supervised Motor Control Exercises Compared To Unsupervised Exercises in Subjects With Chronic Low Back Pain: A Randomized Clinical Trial
The purpose of this study is to compare the added effects of TENS and Supervised Motor Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain and other outcomes.
Descripción general del estudio
Estado
Retirado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic low back pain (CLBP) is a common problem causing disability and high economic burden in globally as well as in Nepal.
There is no consensus on treatment of CLBP, however motor control exercises have good evidence on improvement in pain and disability in CLBP population, whereas transcutaneous electrical nerve stimulation (TENS) is a common treatment of choice with some evidence.
But, we do not know if supervising these motor control exercises (SMCE) and TENS have any added benefit over home exercise program (HEP) which is commonly prescribed mode of exercises.
We plan to conduct a three armed randomized control trial to answer this question to compare effects of SMCE, TENS and HEP versus SMCE and HEP versus HEP alone on disability and pain at two weeks and six months follow up.
Three way-mixed model analysis of Variance (ANOVA) will be used as the statistical test.
Appropriate post hoc analysis will be done to compare within group and between group differences.
Tipo de estudio
Intervencionista
Fase
- No aplica
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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Nonspecific Low back pain for more than 3 months with pain primarily localized between T12 and gluteal folds, if patients report that their pain is provoked and relieved with postures, movement and activities.
- Age between 18 to 65 years
- Male or female
- All educational backgrounds (educated or uneducated)
- Pain intensity more than 2/10 on NPRS and
- Disability of more than 20/100 on NODI
Exclusion Criteria:
- Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
Signs consistent with nerve root compression, this includes any one of the following:
- Reproduction of low back or leg pain with straight leg raise at less than 45 degrees
- Muscle weakness involving a major muscle group of the lower extremity
- Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
- Diminished or absent sensation to pinprick in any lower extremity dermatome
- Prior surgery to the lumbar spine or buttock
- Current pregnancy
- Past medical history of osteoporosis or spinal compression fracture
Participants who do not provide informed consent for the study
-
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 paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: TENS
Participants will receive Active-TENS along with SMCE and UHEP.
Six treatment sessions will be given over two weeks.
Total duration of the treatment session may last from 40 - 60 minutes.
|
Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes.
Otros nombres:
Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles. Initially participants will be taught how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities.
Otros nombres:
All the participants will receive the following treatments:
Otros nombres:
|
|
Experimental: SMCE
Participants will receive SMCE and UHEP.
Six sessions of supervised Motor control exercises will be provided over the period of two weeks.
|
Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles. Initially participants will be taught how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities.
Otros nombres:
All the participants will receive the following treatments:
Otros nombres:
|
|
Comparador activo: UHEP
Unsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session.
|
All the participants will receive the following treatments:
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Disability (Nepali version of Oswestry Disability Index (NODI)
Periodo de tiempo: 2 weeks
|
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal.
The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
|
2 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain intensity (Numerical Pain Rating Scale (NPRS)
Periodo de tiempo: 2 weeks
|
Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours.
|
2 weeks
|
|
Pain intensity (Numerical Pain Rating Scale (NPRS)
Periodo de tiempo: 6 months
|
Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours.
|
6 months
|
|
Disability (Nepali version of Oswestry Disability Index (NODI)
Periodo de tiempo: 6 months
|
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal.
The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
|
6 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in pain and disability (Global Rating of Change (GROC)
Periodo de tiempo: 2 weeks
|
Global Rating of Change (GROC) - The fifteen-point global rating scale will be used.
The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better).
Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
The global rating will be administered at the follow-up examinations only.
|
2 weeks
|
|
Changes in pain and disability (Global Rating of Change (GROC)
Periodo de tiempo: 6 months
|
Using Global rating of change (GROC)
|
6 months
|
|
Need for medication (using frequency and dosage and types of analgesics used)
Periodo de tiempo: 6 months
|
using frequency and dosage and types of analgesics used
|
6 months
|
|
Need for follow up (number of treatment sessions in past six months will be recorded)
Periodo de tiempo: 6 months
|
number of treatment sessions in past six months will be recorded
|
6 months
|
|
Adverse events
Periodo de tiempo: 6 months
|
numbers of adverse events are noted down using a questionnaire
|
6 months
|
|
Fear avoidance (Fear avoidance belief questionnaire (FABQ)
Periodo de tiempo: 6 months
|
Fear avoidance belief questionnaire (FABQ) - The FABQ is a 16-item scale that assesses the influence of fear avoidance behaviors on physical and work activities.
Each item is scored from 0-6 with possible scores ranging between 0-42 and higher scores representing increased fear-avoidance beliefs.
|
6 months
|
|
Pain Catastrophizing (Pain catastrophizing Scale (PCS)
Periodo de tiempo: 6 months
|
Pain catastrophizing Scale (PCS) - Nepali translation of PCS is a 13-item scale that assesses the pain catastrophizing.
Pain catastrophizing is an exaggerated, negative focus on pain and is related to psychological distress, pain severity, and other negative outcomes in pain population.
Participants responded to each item using a Likert-type scale from 0 ('not at all') to 4 ('all the time').
|
6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Saurab Sharma, MPT, Kathmandu University School of Medical Sciences, Nepal
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 (Anticipado)
1 de agosto de 2019
Finalización primaria (Anticipado)
1 de septiembre de 2020
Finalización del estudio (Anticipado)
1 de diciembre de 2020
Fechas de registro del estudio
Enviado por primera vez
15 de enero de 2015
Primero enviado que cumplió con los criterios de control de calidad
21 de enero de 2015
Publicado por primera vez (Estimar)
22 de enero de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
28 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KUSMS107/14
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
producto fabricado y exportado desde los EE. UU.
No
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