Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP
11 febbraio 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
3
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Florida
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Gainesville, Florida, Stati Uniti, 32610-0154
- University of Florida
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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 40 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
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: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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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Comparatore fittizio: 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.
Altri nomi:
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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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fMRI during testing of pain changes from approximately Day 3 and Day 5
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Intensity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Mark D Bishop, PhD, University of Florida
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
1 febbraio 2015
Completamento primario (Effettivo)
1 maggio 2017
Completamento dello studio (Effettivo)
1 maggio 2017
Date di iscrizione allo studio
Primo inviato
24 febbraio 2015
Primo inviato che soddisfa i criteri di controllo qualità
24 febbraio 2015
Primo Inserito (Stima)
2 marzo 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 febbraio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 febbraio 2021
Ultimo verificato
1 febbraio 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB201300827-N
- 3R01AT006334-02S1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
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