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Comparison of the Effect of Spine Grade I and II Manipulation and a PNE Video on Brainwaves: Pilot Study

26 juli 2022 uppdaterad av: Dr. Rob Sillevis,, Florida Gulf Coast University

The Effect of Low-grade Spinal Oscillations Compared to a Pain Neuroscience Education Video on Electroencephalogram (EEG) Brain Activity on Individuals With Chronic Spine Pain: Pilot Study. WITH CHRONIC SPINE PAIN: PILOT STUDY

The purpose of this study is to determine the effect of the use of a pain neuroscience educational video instruction on brainwave activity and compare this to the effects of a grade I & II PA spinal oscillations of the spine using EEG in individuals with chronic pain.

Studieöversikt

Detaljerad beskrivning

This quasi-experimental pilot study compared differences in brainwave activity in subjects with chronic spinal pain following PA spinal oscillations and after viewing a 5-minute pain neuroscience educational video.

In this within subject's design all subjects were given the two interventions on two different days. To prevent the order of the intervention to influence the study results the subjects were randomized into two different groups, A and B. Group A received PA spinal oscillations on their first visit and. Group B's underwent the opposite and watched a pain neuroscience education video on their first visit and received PA spinal oscillations on their first visit. Both sessions and interventions were lead and performed by the Doctor of Physical Therapy student under the direct supervision of the lead physical therapist, who is manually trained and holds a Cranio-Facial Certification. In order to standardize the location of the PA spinal oscillation intervention so brain activity and response can be properly compared, C7, T4 and L4 were identified and marked with a pen prior to any measures. Identification of L4 was achieved by placing hands on the subject's iliac crests with thumbs pointing toward one another. Keeping hands straight and parallel to the floor, thumbs will move medially, landing on L4.25 To identify C7, the subject was taken through cervical extension, where C6 will disappear and C7 remains in place.26 Once C7 was located, the spinous processes were palpated and counted until the level of T4, which was marked. Various factors can affect the reliability of this process, such as subject obesity, therapist experience, and anatomical differences.25 Studies show reliability for this method to be low.25,26 However, these studies, as with most, use a small sample size and only using one palpatory landmark for each level examined.25,26 To standardize variables, the methods above were used in conjunction with palpation of surrounding vertebrae. To measure brain wave activity during this study the 14-lead Emotiv EPOC portable EEG headset was used. Each participant wore the headset throughout the measurement and was in a seated position. After the EEG headset was placed properly and connection with the system had been appropriately established the subjects remained seated in a quiet room for three minutes to accommodate to the room environment before the first EEG measurement. After this, a 1-minute EEG recording was taken. This measurement served as the participant's baseline measurement. Group A subjects then received a grade I & II spinal oscillations of three identified segments (C7, T4, and L4), 1 minute per segment for a total of 3 minutes. Directly following this a second 1-minute EEG recording was taken. On the subsequent visit, group A again underwent the three-minute seated accommodation period with the EEG headset on, followed by a 1 minute baseline EEG measurement prior to watching a 5 minute pain neuroscience educational video Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI. A 1-minute EEG recording was taken during the first minute of the video and again during the last minute of the video. Immediately after watching the pain neuroscience educational video a 1-minute EEG recording was taken. The measurement protocol for group B was the same, but in reversed order. They watched the pain neuroscience educational video at their first visit and the PA spinal oscillations on their next visit.

Studietyp

Interventionell

Inskrivning (Faktisk)

20

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Indiana
      • Merrillville, Indiana, Förenta staterna, 46410
        • Integrated therapy Practice PC

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

Subjects in this study were males and female between the ages of 20 to 65 years with chronic lower back pain (> 3 months). Exclusion Criteria:

Exclusion Criteria:

were not meeting the age requirement having pain less than three months having conditions that would be a contraindication for the grade I-II PA spinal oscillations Those with known neurological conditions making EEG measures unreliable.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: PNE group
5 minute video :Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI.
Watching pain neuroscience education video
Low grade PA manipulation on the cervical, thoracic and lumbar spine
Aktiv komparator: Manipulation group
PA grade I-II oscillation on C7, T4 and L4
Watching pain neuroscience education video
Low grade PA manipulation on the cervical, thoracic and lumbar spine

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
EEG power in alpha, delta, gamma, and theta waves
Tidsram: 4- 10 seconds measures of all wave bands in one session measures
alpha, delta, gamma, and theta waves brain wave measures
4- 10 seconds measures of all wave bands in one session measures

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 juni 2020

Primärt slutförande (Faktisk)

2 augusti 2020

Avslutad studie (Faktisk)

1 januari 2022

Studieregistreringsdatum

Först inskickad

6 maj 2021

Först inskickad som uppfyllde QC-kriterierna

26 maj 2021

Första postat (Faktisk)

1 juni 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 juli 2022

Senast verifierad

1 juli 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2020-30

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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