The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Muscle Thickness of the Sacral Multifidi, Lumbar Motion, and Self-Reported Pain
The purpose of this experiment is to determine the effects of a non-thrust manipulation procedure on muscle function, spinal mobility, and pain level on those experiencing low back pain (LBP) in a sample of individuals who identify English as their primary language. The rationale for this language criterion is provided in Section 9:F of this application. Muscle function will be measured via the muscle thickness of a deep spinal stabilizing muscle (multifidus, MF) while in both a resting state and during a maximum voluntary contraction (MVC). Spinal mobility will be measured as the active range of motion of both forward and backward trunk bending. Pain level will be a self-report measure recorded during rest and active range of motion.
Hypothesis 1: A non-thrust manipulation procedure will increase the thickness of the sacral multifidus both at rest and during a maximum voluntary contraction
Hypothesis 2: A non-thrust manipulation procedure will result in greater low back active range of motion.
Hypothesis 3: A non-thrust manipulation procedure will result in a reduction in the participant's self-reported pain levels both at rest and during active range of motion movements.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Reading, Pennsylvania, 미국, 19606
- Alvernia University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants are individuals with current complaint of low back pain, defined as pain that is present in the region from just below the rib cage to just below the buttocks.
- Participants will be 18 years of age or older
- Participants must be experiencing an episode of low back pain at the present time that is at any level on a Numerical Pain Rating Scale & Pain Diagram (NPRS) from 1-10
- Participants must demonstrate the ability to maintain standing and prone postures for several minutes at a time and perform lumbar active range of motion in a standing position
- Participants must report the presence of their low back pain during performance of active forward and/or backward bending in standing
- Participants must demonstrate the ability to communicate in conversational English, that includes speaking, reading, and writing.
Exclusion Criteria:
- Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
- Participants with known or suspected pregnancy
Participants with confirmed diagnosis of any of the following conditions:
- Central nervous system disorder
- Rheumatoid Arthritis
- Spinal Fracture
- Spondyloarthropathy (i.e., Ankylosing Spondylitis)
- Tumor or infection of the spine
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Lumbar Manipulation Group
Group that receives experimental lumbar non-thrust manipulation
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Lumbar non-thrust manipulation is a passive movement that is performed with a rhythm and a grade in a manner in which the patient is able to prevent the technique from being performed.
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가짜 비교기: Sham Manipulation Group
Group that receives sham lumbar non-thrust manipulation
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Lumbar non-thrust manipulation without force applied
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Sacral Multifidus Muscle Thickness
기간: Change from Pre to immediately Post Manipulation/Sham
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Rehabilitation Ultrasound Images of Sacral Multifidus muscle thickness at rest and during a maximal isometric contraction
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Change from Pre to immediately Post Manipulation/Sham
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in Lumbar Active Range of Motion
기간: Change from Pre to immediately Post Manipulation/Sham
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Inclinometry of Lumbar Active Range of Motion in Standing
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Change from Pre to immediately Post Manipulation/Sham
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Changes in Low Back Pain
기간: Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
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Visual Analogue Scale of Low Back Pain (0-10 scale with 0=least pain, 10=worst pain)
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Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
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Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)
기간: Change from Baseline to 24-48 hours post session
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)
기간: Change from Baseline to 24-48 hours post session
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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Changes in Global Rating of Change (-7 to +7 scale, -7=a very great deal worse, +7=a very great deal better)
기간: Change from Baseline to 24-48 hours post session
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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공동 작업자 및 조사자
수사관
- 연구 의자: Joshua Cleland, PhD, Nova Southeastern University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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