만성 요통 환자의 운동, PNE 및 인지 훈련
특발성 만성 요통이 있는 개인의 통증 신경 과학 교육, 운동 및 인지 훈련: 3군 무작위 시험
This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).
연구 개요
상세 설명
This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education (PNE) will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).
It will have three arms of which will receive exercise, PNE and/or cognitive training for 8 weeks (Group I - exercise and PNE; Group II - exercise, PNE and cognitive training; Group III - cognitive training).
Participants will be assessed for pain characteristics, psychological, and cognitive aspects at baseline, post-intervention and at 3 months follow-up.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Aveiro District
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Aveiro, Aveiro District, 포르투갈
- University of Aveiro
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- have chronic idiopathic LBP
- report pain intensity of at least 2 out of 10 on the Numeric Pain Rating Scale
- 18 to 64 years old
- Be able to read, write and speak Portuguese
- Asses to personal computer and internet for those receiving cognitive training
Exclusion Criteria:
- individuals receiving any chronic treatment for their pain
- symptoms of peripheral nervous system pathology (e.g., motor weakness and sensory disturbance);
- a diagnosis of an ongoing neurological disease with peripheral or central nervous system involvement or relevant sequela;
- having a diagnosis of ongoing psychiatric disease
- having relevant cognitive impairment as assessed by Montreal Cognitive Assessment (MoCA).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention 1
Participants will receive exercise, PNE and online cognitive training sessions. |
Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education). |
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활성 비교기: Intervention 2
Participants will receive exercise and pain neuroscience education (PNE). |
Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education). |
|
활성 비교기: Intervention 3
Participants will receive online cognitive training sessions. |
Online sessions of cognitive training. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Numeric Pain Rating Scale Numeric Pain Rating Scale
기간: baseline
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Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable". |
baseline
|
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Numeric Pain Rating Scale Numeric Pain Rating Scale
기간: post-intervention - 8 weeks
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Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable". |
post-intervention - 8 weeks
|
|
Numeric Pain Rating Scale Numeric Pain Rating Scale
기간: 3 months follow-up
|
Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable". |
3 months follow-up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cognitive Function
기간: baseline
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Cognitive function will be assessed using the Brain on Track® (BoT), a self-administered computerized test that evaluates different cognitive domains. Each test has a virtually unlimited range score and considers the maximum number of correct answers that a person gives in a fixed period of time and higher scores represent higher cognitive performance. |
baseline
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Cognitive Function
기간: post-intervention - 8 weeks
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Cognitive function will be assessed using the Brain on Track® (BoT), a self-administered computerized test that evaluates different cognitive domains. Each test has a virtually unlimited range score and considers the maximum number of correct answers that a person gives in a fixed period of time and higher scores represent higher cognitive performance. |
post-intervention - 8 weeks
|
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Cognitive Function
기간: 3 months follow-up.
|
Cognitive function will be assessed using the Brain on Track® (BoT), a self-administered computerized test that evaluates different cognitive domains. Each test has a virtually unlimited range score and considers the maximum number of correct answers that a person gives in a fixed period of time and higher scores represent higher cognitive performance. |
3 months follow-up.
|
|
Roland Morris disability questionnaire
기간: baseline
|
The Roland Morris assesses disability caused by LBP. It has 24 statements, and the individual must tick those that relate to him that day. The total score ranges from "0" meaning no disability to "24" meaning maximum disability. |
baseline
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Roland Morris disability questionnaire
기간: post-intervention - 8 weeks
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The Roland Morris assesses disability caused by LBP. It has 24 statements, and the individual must tick those that relate to him that day. The total score ranges from "0" meaning no disability to "24" meaning maximum disability. |
post-intervention - 8 weeks
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Roland Morris disability questionnaire
기간: 3 months follow-up
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The Roland Morris assesses disability caused by LBP. It has 24 statements, and the individual must tick those that relate to him that day. The total score ranges from "0" meaning no disability to "24" meaning maximum disability. |
3 months follow-up
|
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Central sensitization Inventory
기간: baseline
|
The central sensitization inventory (CSI) assesses symptoms of central sensitization. The total score ranges from 0 to 100 points and to identify central sensitization in individuals, the recommended cut-off score is 40 points. |
baseline
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Central sensitization Inventory
기간: post-intervention - 8 weeks
|
The central sensitization inventory (CSI) assesses symptoms of central sensitization. The total score ranges from 0 to 100 points and to identify central sensitization in individuals, the recommended cut-off score is 40 points. |
post-intervention - 8 weeks
|
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Central sensitization Inventory
기간: 3 months follow-up
|
The central sensitization inventory (CSI)assesses symptoms of central sensitization. The total score ranges from 0 to 100 points and to identify central sensitization in individuals, the recommended cut-off score is 40 points. |
3 months follow-up
|
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Hospital Anxiety and Depression Scale (HADS)
기간: baseline
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HADS evaluates symptoms of anxiety and depression. The total scores range from 0 to 21 points with a 4-point Likert scale rating between "most of the times" and "not at all" with higher scores indicating higher levels of anxiety and depression. |
baseline
|
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Hospital Anxiety and Depression Scale (HADS)
기간: post-intervention - 8 weeks
|
HADS evaluates symptoms of anxiety and depression. The total scores range from 0 to 21 points with a 4-point Likert scale rating between "most of the times" and "not at all" with higher scores indicating higher levels of anxiety and depression. |
post-intervention - 8 weeks
|
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Hospital Anxiety and Depression Scale (HADS)
기간: 3 months follow-up.
|
HADS evaluates symptoms of anxiety and depression. The total scores range from 0 to 21 points with a 4-point Likert scale rating between "most of the times" and "not at all" with higher scores indicating higher levels of anxiety and depression. |
3 months follow-up.
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TAMPA Scale of Kinesiophobia
기간: baseline
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The Tampa scale measures the fear of movement related to chronic LBP. The short version has 13 items in a 4-point Likert scale rating between "strongly disagree" and "strongly agree". The total scores range from 0 to 52 points with higher levels indicating higher fear of movement. |
baseline
|
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TAMPA Scale of Kinesiophobia
기간: post-intervention - 8 weeks
|
The Tampa scale measures the fear of movement related to chronic LBP. The short version has 13 items in a 4-point Likert scale rating between "strongly disagree" and "strongly agree". The total scores range from 0 to 52 points with higher levels indicating higher fear of movement. |
post-intervention - 8 weeks
|
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TAMPA Scale of Kinesiophobia
기간: 3 months follow-up.
|
The Tampa scale measures the fear of movement related to chronic LBP. The short version has 13 items in a 4-point Likert scale rating between "strongly disagree" and "strongly agree". The total scores range from 0 to 52 points with higher levels indicating higher fear of movement. |
3 months follow-up.
|
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Pain Catastrophizing Scale
기간: Baseline
|
The Pain Catastrophizing Scale (PCS) assess catastrophic thinking related to pain. It has 13 statements on a 5-point scale ranging from 0 meaning "not at all" and 4 meaning "all the time". The total score ranges from 0 to 52 with higher scores indicating higher levels of catastrophizing. |
Baseline
|
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Pain Catastrophizing Scale
기간: post-intervention - 8 weeks
|
The Pain Catastrophizing Scale (PCS) assess catastrophic thinking related to pain. It has 13 statements on a 5-point scale ranging from 0 meaning "not at all" and 4 meaning "all the time". The total score ranges from 0 to 52 with higher scores indicating higher levels of catastrophizing. |
post-intervention - 8 weeks
|
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Pain Catastrophizing Scale
기간: 3 months follow-up.
|
The Pain Catastrophizing Scale (PCS) assess catastrophic thinking related to pain. It has 13 statements on a 5-point scale ranging from 0 meaning "not at all" and 4 meaning "all the time". The total score ranges from 0 to 52 with higher scores indicating higher levels of catastrophizing. |
3 months follow-up.
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Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
기간: baseline
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The scale assess the difficulties with sleep onset and maintenance and the quality and depth of sleep during the last month and considering a normal week. Total score ranges from 0 to 28 points and higher scores are associated with poor quality of sleep. |
baseline
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Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
기간: post-intervention - 8 weeks
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The scale assess the difficulties with sleep onset and maintenance and the quality and depth of sleep during the last month and considering a normal week. Total score ranges from 0 to 28 points and higher scores are associated with poor quality of sleep. |
post-intervention - 8 weeks
|
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Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
기간: 3 months follow-up.
|
The scale assess the difficulties with sleep onset and maintenance and the quality and depth of sleep during the last month and considering a normal week. Total score ranges from 0 to 28 points and higher scores are associated with poor quality of sleep. |
3 months follow-up.
|
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Two-point discrimination
기간: baseline
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Two-point discrimination is used to assess cortical reorganization. |
baseline
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Two-point discrimination
기간: post-intervention - 8 weeks
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Two-point discrimination is used to assess cortical reorganization. |
post-intervention - 8 weeks
|
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Two-point discrimination
기간: 3 months follow-up
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Two-point discrimination is used to assess cortical reorganization. |
3 months follow-up
|
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Patient's Global Impression of Change (PGIC)
기간: post-intervention - 8 weeks
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PGIC evaluates the perception of improvement associated with the intervention. Participants are instructed to select on a scale from 1 ("No change or condition worsened") to 7 ("Much better, and with a considerable improvement that made all the difference") the statement that best reflected the impact of the intervention on their condition. |
post-intervention - 8 weeks
|
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Patient's Global Impression of Change (PGIC)
기간: 3 months follow-up.
|
PGIC evaluates the perception of improvement associated with the intervention. Participants are instructed to select on a scale from 1 ("No change or condition worsened") to 7 ("Much better, and with a considerable improvement that made all the difference") the statement that best reflected the impact of the intervention on their condition. |
3 months follow-up.
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Anabela Silva, PhD, School of Health Sciences, University of Aveiro
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- RCTCognitiveTraining
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data are not publicly available due to ethical and privacy restrictions of the approved study protocol. An anonymized analysis dataset may be made available to qualified researchers upon reasonable request to the principal investigator and subject to approval by the Ethics and Deontology Council of the University of Aveiro.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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