- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03635242
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Post-treatment Healed Patients by Therapeutic Exercise
연구 개요
상태
상세 설명
The records are made simultaneously with the different evaluation equipment, accelerometer and pressure platform. The tests are performed in a control group of healthy subjects, and in an experimental group with DLC receiving a program of therapeutic exercise based and pain education based on neuroscience.
After the collection of the records, the behavior patterns in both groups are evaluated, the possible differences among them are established for the clinimetric indicators analyzed related to the postural control, as well as a characteristic of the sample.
Subsequently, through the evaluation after the intervention of the experimental group we will analyze the effect of a physiotherapy treatment based on the therapeutic exercise of motor control on parameters related to postural control and clinical variables (perceived pain, mechanosensitivity, disability and proprioceptive repositioning of the lumbar spine )
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Badajoz, 스페인, 06071
- Universidad de Extremadura
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- low back pain with painful perception on a daily or almost daily basis for more than three months of clinical course, with or without pain radiating to the lower extremities above the knee.
- not having metal implants in the spine
- own ability to read and write
- and access the study voluntarily.
Exclusion Criteria:
- vestibular disorders
- without severe visual impairment
- no medication intake with a potential effect on balance during the 90 days prior to data collection
- physiotherapy treatment 2 weeks before the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Control. no therapeutic program
The control group continued to perform their daily activities without changing any habit.
Group of healthy subjects Assessment of postural control through accelerometry and pressure platform
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The control group continued to perform their daily activities without changing any habit.
Group of healthy subjects Assessment of postural control through accelerometry and pressure platform
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실험적: Experimental. Therapeutic program
People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months. Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform |
People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months. Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
pressure platform and accelerometry
기간: 4 weeks
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Stay for 30 seconds each test on a pressure platform.
Accelerometer in the pelvis (center of mass), fixed by velcro tape.
Application of the Romberg test.
(Standing with open eyes and closed on stable and unstable surface).The unit of the accelerometer is mg (1 mg = 0.001) and the kinetic energy of the signal is measured in Julians x 10-6 The displacement unit of the pressure center of the platform is millimeters
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4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
weight
기간: 4 weeks
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Descriptive variable.
Its unit of measurement is Kilograms
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4 weeks
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Height
기간: 4 weeks
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Descriptive variable.
Its unit of measurement is meters
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4 weeks
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age
기간: 4 weeks
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Descriptive variable.
Its unit of measurement is years
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4 weeks
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EVA (Visual Analog Scale).
기간: 4 weeks
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Used for pain assessment in an analogical way, that is, by means of a line of 10 centimeters.
0 (absence of pain); 10 (maximum pain)
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4 weeks
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Algometry
기간: 4 weeks
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Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)
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4 weeks
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Joint Position Sense (JPS)
기간: 4 weeks
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Joint Position Sense (JPS) to evaluate the proprioceptive joint positioning of the lumbar spine with a digital goniometer at 30º flexion in standing and sitting
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4 weeks
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Roland Morris
기간: 4 weeks
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determine the degree of disability.
The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
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4 weeks
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Oswestry Disability Index
기간: 4 weeks
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The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability Scoring instructions For each section of the total possible score is 5: if the first statement is mark ed the section score = 0; if the last statement is marked, it = 5. |
4 weeks
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Pain Catastrophizing Scale (PCS)
기간: 4 weeks
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it measures the catastrophic thoughts before the pain, that is, the negative thought before the pain. In the PCS, people take the painful past experience as a reference and indicate the degree to which they experience certain thoughts and feelings. The PCS is composed of 13 items, on a Likert scale of 5 points that goes from 0 (never) to 4 (always). Higher scores indicate higher levels of catastrophism |
4 weeks
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The Tampa Kinesiofobia Scale (TSK)
기간: 4 weeks
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It is commonly used in clinical practice to quantify pain levels related to fear of activity or to a new injury in patients with back pain.
Patients with high levels of kinesiofobia are often considered at greater risk of developing long-term activity limitation and chronicity
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4 weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: Mª Dolores MD Apolo-Arenas, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- 연구 책임자: Luis LE Espejo-Antúnez, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- 수석 연구원: Alejandro Caña-Pino, PT,MSc, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
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 연구와 관련된 용어
기타 연구 ID 번호
- 08062018
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