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Набор по приглашению NCT06965920

Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control

Наблюдательное Spine Condition Low Back Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Spine Condition, Low Back Pain. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.

Подробное описание

Objective This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.

Methods:

All patients who can stand without severe pain (able to stand normally at a 7 or below on qualitative analog visual pain scale \[QVAS\]) will be invited to participate. The goal is to recruit 150 participants from approximately 10 chiropractic practices. Volunteers will be given an informed consent document to read and if eligible and willing to participate will sign the informed consent document. At baseline and each subsequent testing visit, participants will complete the following:

* a numerical pain rating index (0-10) for each of the following: headache, neck pain, mid back pain and low back pain * Keele STarT Back Screening Tool * Assessment of Balance Confidence Questionnaire (ABC-6) * Posture testing via force plate: Modified Test of Sensory Integration and Balance (MCTSIB), Single leg stance, limits of stability, * Timed up and go and 5 times sit to stand tests The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.

The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.

Первичные конечные точки

  • Modified Test of Sensory Integration and Balance (MCTSIB) score [Срок оценки: From enrollment to end of 4 weeks and 8 weeks of treatment]
Вторичные конечные точки (7)
  • Numerical pain rating scale (0-10) on neck pain, mid-back pain, and low back pain [Срок оценки: From enrollment to end of 4 weeks and 8 weeks of treatment]
  • Limits of balance while standing on a force plate [Срок оценки: From enrollment to end of 4 weeks and 8 weeks of treatment]
  • path length of center of pressure while standing on a single leg stance [Срок оценки: From enrollment to end of 4 weeks and 8 weeks of treatment]
  • Timed up and Go test in seconds [Срок оценки: From enrollment to end of 4 weeks and 8 weeks of treatment]
  • time to Sit-to-stand test for 5 repetetions [Срок оценки: From enrollment to end of 4 weeks and 8 weeks of treatment]
  • • Keele STaRT Back [Срок оценки: From enrollment to end of 4 weeks and 8 weeks of treatment]
  • • Assessment of Balance Confidence Questionnaire (ABC-6) [Срок оценки: From enrollment to end of 4 weeks and 8 weeks of treatment]

Критерии участия

Критерии включения

  • New patients with spinal pain,
  • Patients will be between 18-100 years of age.
  • All patients with spinal pain who - can safely stand and perform the basic parameters of the test at a 7 or below on qualitative visual analog scale (QVAS) on pain will be invited to participate.

Критерии исключения

-Patients unable to stand normally with more than a 7 / 10 on the QVAS.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Keiser University Spine care clinic — West Palm Beach

Идентификаторы

NCT: NCT06965920 · IRB000NV23MG145

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗