Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP
11. Februar 2021 aktualisiert von: University of Florida
CENTRAL MECHANISMS OF BODY BASED INTERVENTION FOR MUSCULOSKELETAL LOW BACK PAIN: Feasibility Assessment of Neurophysiological Measurement in Veterans With Low Back Pain
This is study testing the feasibility of collecting neurophysiological measures of outcome related to body-based interventions for low back pain.
The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the interventions.
Participants will be randomly assigned to either spinal manipulation or therapeutic touch groups.
Participants will attend two practice sessions prior to the first data collection.
There will be two follow-up assessments.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
Participants will be enrolled from VA pain clinical at the North Florida/South George VA Medical Center.
The investigators will collect functional magnetic resonance imaging data of resting state and pain-related events (i.i. during thermal pain sensitivity testing, as well as psychophysical data to determine pain sensitivity. Pain sensitivity will be measured using thermal and mechanical stimuli. These data will be collected before and after the interventions, in addition to two follow-up sessions after intervention.
In addition, clinical measures of pain intensity in the low back, as well as trunk range of motion and strength will also be collected.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
3
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Florida
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Gainesville, Florida, Vereinigte Staaten, 32610-0154
- University of Florida
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 40 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- complaints of current back pain that they rate at least 40 on a 101-point numeric rating scale
- Participants must able to understand written and spoken English
Exclusion Criteria:
- currently receiving treatment for LBP or have received SMT for LBP in the past year
- Quebec Task Force on Spinal Disorders (QTFSD) to identify patients with pre-existing nerve root compression, spinal stenosis, or post-surgery
- any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches)
- any contraindication to MRI
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Spinal manipulation
Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain .
The SMT will be performed four times (two times on each side) in a 5-minute period.
In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
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Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain .
The SMT will be performed four times (two times on each side) in a 5-minute period.
In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
Both groups will receive an fMRI.
Andere Namen:
Both groups will receive an Pain Sensitivity Testing
Both groups will receive Questionnaires
Both groups will receive testing on physical impairment.
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Schein-Komparator: Therapeutic touch
Participants in this group will lie prone.
The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table.
This group accounts for effects of time and personal contact.
The amount of "hands-on" contact will be equivalent between groups.
Both groups will be given the same verbal instructions regarding the techniques performed.
In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
|
Both groups will receive an fMRI.
Andere Namen:
Both groups will receive an Pain Sensitivity Testing
Both groups will receive Questionnaires
Both groups will receive testing on physical impairment.
Participants in this group will lie prone.
The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table.
This group accounts for effects of time and personal contact.
The amount of "hands-on" contact will be equivalent between groups.
Both groups will be given the same verbal instructions regarding the techniques performed.
In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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fMRI during testing of pain changes from approximately Day 3 and Day 5
Zeitfenster: Change from approximately Day 3 and Day 5
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Change from approximately Day 3 and Day 5
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fMRI during quite rest changes from approximately Day 3 and Day 5
Zeitfenster: Change from approximately Day 3 and Day 5
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Change from approximately Day 3 and Day 5
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Pain Sensitivity Testing changes from Day 3, Day 4 and Day 5
Zeitfenster: Change from Day 3, Day 4 and Day 5
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This measure thermal threshold and tolerance using continuous heat stimulus delivered to the participants' dominant arm.
The stimulus will start at 35°C and will be increased at a rate of 0.5°C with participants terminating the stimulus when the temperature reached pain threshold ("when the sensation first transitions from heat to pain") and tolerance ("when the sensation becomes so strong you want to remove it from your skin").
Threshold and tolerance measures will also be collected using mechanical pressure applied using a Fischer Dolorimeter.
During Dolorimeter testing, force is slowly increased until the subject indicates that the sensation changes from pressure to pain.
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Change from Day 3, Day 4 and Day 5
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pain Intensity
Zeitfenster: Change from Day 3, Day 4 and Day 5
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Pain visual analog scale is a 10cm long line.
The line is anchored at one end with 'none' or 'not bad at all' and at the other with 'worst imaginable.' Participants are asked to rate their pain at rest by placing a mark along the 10cm line.
Participants will also rate pain during active trunk range of motion using the same scale.
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Change from Day 3, Day 4 and Day 5
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McGill Pain Questionnaire-2
Zeitfenster: Change from Day 3, Day 4 and Day 5
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This is 22-item questionnaire that asks participants to describe the intensity of varies qualities of the pain that he or she is experiencing; for example, throbbing or itching.
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Change from Day 3, Day 4 and Day 5
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Physical Impairment
Zeitfenster: Change from Day 3, Day 4 and Day 5
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A physical impairment scale consists of 7 different examination procedures that assess lumbar and hip range of motion, muscle performance of trunk musculature, and response to palpation.
Scores is 0 - 8, Range is 0 is no impairment and 8 is completely impaired.
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Change from Day 3, Day 4 and Day 5
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Oswestry Disability Questionnaire (ODQ)
Zeitfenster: Change from Day 3, Day 4 and Day 5
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The ODQ has a range of 0 (no disability due to back pain) to 100 (completely disabled due to back pain), so higher scores indicate higher disability from LBP.
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Change from Day 3, Day 4 and Day 5
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Mark D Bishop, PhD, University of Florida
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2015
Primärer Abschluss (Tatsächlich)
1. Mai 2017
Studienabschluss (Tatsächlich)
1. Mai 2017
Studienanmeldedaten
Zuerst eingereicht
24. Februar 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. Februar 2015
Zuerst gepostet (Schätzen)
2. März 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Februar 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. Februar 2021
Zuletzt verifiziert
1. Februar 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB201300827-N
- 3R01AT006334-02S1 (US NIH Stipendium/Vertrag)
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