- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02343315
Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?
Effectiveness of TENS and Supervised Motor Control Exercises Compared To Unsupervised Exercises in Subjects With Chronic Low Back Pain: A Randomized Clinical Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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.
Andere Namen:
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.
Andere Namen:
All the participants will receive the following treatments:
Andere Namen:
|
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.
Andere Namen:
All the participants will receive the following treatments:
Andere Namen:
|
Aktiver Komparator: 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:
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Disability (Nepali version of Oswestry Disability Index (NODI)
Zeitfenster: 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)
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2 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Pain intensity (Numerical Pain Rating Scale (NPRS)
Zeitfenster: 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)
Zeitfenster: 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.
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6 months
|
Disability (Nepali version of Oswestry Disability Index (NODI)
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Changes in pain and disability (Global Rating of Change (GROC)
Zeitfenster: 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)
Zeitfenster: 6 months
|
Using Global rating of change (GROC)
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6 months
|
Need for medication (using frequency and dosage and types of analgesics used)
Zeitfenster: 6 months
|
using frequency and dosage and types of analgesics used
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6 months
|
Need for follow up (number of treatment sessions in past six months will be recorded)
Zeitfenster: 6 months
|
number of treatment sessions in past six months will be recorded
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6 months
|
Adverse events
Zeitfenster: 6 months
|
numbers of adverse events are noted down using a questionnaire
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6 months
|
Fear avoidance (Fear avoidance belief questionnaire (FABQ)
Zeitfenster: 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.
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6 months
|
Pain Catastrophizing (Pain catastrophizing Scale (PCS)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Saurab Sharma, MPT, Kathmandu University School of Medical Sciences, Nepal
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KUSMS107/14
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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