- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07582705
Measuring Reliability of Spine Mobilization in Low Back Pain
This observational study aims to learn how to measure joint motion and tissue response when pressure is applied to the back and examine how the nervous system responds to the applied pressure. This pressure or mobilization technique is a standard care but we currently do not have a method to measure this technique. Through this study, we hope to validate a tool that allows physical therapists to measure the pressure applied during spinal mobilization.
Participants will be asked to:
- Receive spinal mobilization
- Participate in pain threshold testing
- Answer questionnaires
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Kansas
-
Kansas City, Kansas, Yhdysvallat, 66103
- University of Kansas Medical Center
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Healthy individuals without current or recent history (within 6 months) of low back pain
- 18-70 years of age
- BMI between 18.5-29.9
- Ability to read and understand English
- For those with chronic low back pain: 1) low back pain more than 3 months and 2) a minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days
Exclusion Criteria:
- Any signs or symptoms of lumbar pathology (as reported by the participant during interview such as low back pain, or lower limb neurological signs)
- History of any spinal surgery
- Lumbar/sacral conditions reported by the subject such as spondylolithesis, spina bifida or spinal fracture
- Bony pathology such as osteoporosis or rheumatoid arthritis as reported by the participant
- Pregnancy
- Spine cancer
- BMI >30
- Unable to lay on stomach
- Resting blood pressure more than 160/90 mmHg
- Currently taking blood thinning medications
- Uncontrolled diabetes
- A medical exclusion from having blood pressure taken such as a peripheral neuropathy
- Low signal to noise ratio fNIRS signal during calibration/setup
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
Healthy Participants
Spinal mobilization
|
The application of manual pressure to stiff spinal segments to improve mobility and control pain.
|
|
Chronic Low Back Pain Participants
Spinal mobilization
|
The application of manual pressure to stiff spinal segments to improve mobility and control pain.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system.
Aikaikkuna: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The amount of joint motion for a given grade as measured by the laboratory methods and from the lumbar mobilization feedback system.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Applied forces as measured by the laboratory methods and lumbar mobilization feedback system
Aikaikkuna: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The magnitude of force produced by the clinician for each grade as measured by the laboratory methods and lumbar mobilization feedback system
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Tissue resistance as measured by laboratory methods and the lumbar mobilization feedback system
Aikaikkuna: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The degree of stiffness of the joint measured as measured by laboratory methods and the lumbar mobilization feedback system
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Change in muscle activation as measured by electromyography
Aikaikkuna: Change from Baseline (day1) to immediately post-treatment (day 1)
|
Differences in recorded electromyography (EMG) activity before and after administration of the intervention
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Change in pain threshold as measured by quantitative sensory testing.
Aikaikkuna: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The following tests will be used to test sensation threshold before and after grade I - IV mobilization/clinician: pressure pain threshold, conditioned pain modulation, and temporal summation.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Brain functional connectivity as measured by functional near infrared spectroscopy
Aikaikkuna: Change from Baseline (day1) to immediately post-treatment (day 1)
|
Functional near infrared spectroscopy (fNIRS) is a portable, non-invasive, and inexpensive brain imaging method of monitoring cerebral hemodynamic activity.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- STUDY00148661
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