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Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?

28 marzo 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Ritirato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. 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.
  2. Age between 18 to 65 years
  3. Male or female
  4. All educational backgrounds (educated or uneducated)
  5. Pain intensity more than 2/10 on NPRS and
  6. Disability of more than 20/100 on NODI

Exclusion Criteria:

  1. 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.)

  2. Signs consistent with nerve root compression, this includes any one of the following:

    1. Reproduction of low back or leg pain with straight leg raise at less than 45 degrees
    2. Muscle weakness involving a major muscle group of the lower extremity
    3. Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
    4. Diminished or absent sensation to pinprick in any lower extremity dermatome
  3. Prior surgery to the lumbar spine or buttock
  4. Current pregnancy
  5. Past medical history of osteoporosis or spinal compression fracture

  6. Participants who do not provide informed consent for the study

    -

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: TENS

Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes.

  • Equipment- TENS (CEFAR Basic TENS Machine)
  • Electrodes- Four channel electrode to cover the site of pain
  • Site of electrode placement- will be decided by the physical therapist to best suit or cover the area of pain based on complaints of patient based on the body chart.
  • Intensity- the intensity will be increased progressively until maximum tolerable intensity is reached. This stimulation may cause visible muscle contraction. This type of current is also referred to as Motor-level TENS, which is effective for chronic pain. The intensity will not be increased beyond 25 milli Amperes if no sensation is perceived by the patient.
  • Frequency- 5 Hertz
  • Duration- 30 minutes
Altri nomi:
  • stimolazione nervosa elettrica transcutanea
  • stimolazione elettrica transcutanea
  • transcutenous nerve stimulation
  • Low TENS
  • Motor level TENS
Altro: SMCE

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.

Altri nomi:
  • esercizi di stabilità del core
  • spinal stabilization exercises
  • Supervised motor control exercises
Altro: UHEP

All the participants will receive the following treatments:

  1. Unsupervised home exercise program- which includes series of motor control exercises along with specific exercises including stretching exercises based on impairments.
  2. Education in terms of body mechanics, ergonomics advises and educational leaflet in the form of Nepali version of Back book which includes, evidence based advises about back pain self-management, advice to remain active. Treating physical therapist will educate all the participants in the first intervention session.
  3. Participants will not be asked to not take the "over the counter" analgesics including Acetaminophen or Non-inflammatory anti-inflammatory drugs (ibuprofen).
Altri nomi:
  • home exercise program
  • Unsupervised home exercise program
Sperimentale: SMCE
Participants will receive SMCE and UHEP. Six sessions of supervised Motor control exercises will be provided over the period of two weeks.
Altro: SMCE

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.

Altri nomi:
  • esercizi di stabilità del core
  • spinal stabilization exercises
  • Supervised motor control exercises
Altro: UHEP

All the participants will receive the following treatments:

  1. Unsupervised home exercise program- which includes series of motor control exercises along with specific exercises including stretching exercises based on impairments.
  2. Education in terms of body mechanics, ergonomics advises and educational leaflet in the form of Nepali version of Back book which includes, evidence based advises about back pain self-management, advice to remain active. Treating physical therapist will educate all the participants in the first intervention session.
  3. Participants will not be asked to not take the "over the counter" analgesics including Acetaminophen or Non-inflammatory anti-inflammatory drugs (ibuprofen).
Altri nomi:
  • home exercise program
  • Unsupervised home exercise program
Comparatore attivo: 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.
Altro: UHEP

All the participants will receive the following treatments:

  1. Unsupervised home exercise program- which includes series of motor control exercises along with specific exercises including stretching exercises based on impairments.
  2. Education in terms of body mechanics, ergonomics advises and educational leaflet in the form of Nepali version of Back book which includes, evidence based advises about back pain self-management, advice to remain active. Treating physical therapist will educate all the participants in the first intervention session.
  3. Participants will not be asked to not take the "over the counter" analgesics including Acetaminophen or Non-inflammatory anti-inflammatory drugs (ibuprofen).
Altri nomi:
  • home exercise program
  • Unsupervised home exercise program

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disability (Nepali version of Oswestry Disability Index (NODI)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain intensity (Numerical Pain Rating Scale (NPRS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in pain and disability (Global Rating of Change (GROC)
Lasso di tempo: 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)
Lasso di tempo: 6 months
Using Global rating of change (GROC)
6 months
Need for medication (using frequency and dosage and types of analgesics used)
Lasso di tempo: 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)
Lasso di tempo: 6 months
number of treatment sessions in past six months will be recorded
6 months
Adverse events
Lasso di tempo: 6 months
numbers of adverse events are noted down using a questionnaire
6 months
Fear avoidance (Fear avoidance belief questionnaire (FABQ)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Kathmandu University School of Medical Sciences

Investigatori

  • Investigatore principale: Saurab Sharma, MPT, Kathmandu University School of Medical Sciences, Nepal

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 agosto 2019

Completamento primario (Anticipato)

1 settembre 2020

Completamento dello studio (Anticipato)

1 dicembre 2020

Date di iscrizione allo studio

Primo inviato

15 gennaio 2015

Primo inviato che soddisfa i criteri di controllo qualità

21 gennaio 2015

Primo Inserito (Stima)

22 gennaio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KUSMS107/14

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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