- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07671196
Validity and Reliability of Arabic Version of Extended Aberdeen Spine Pain Scale
The goal of this observational study is to determine whether the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) is a valid and reliable tool for assessing spine-related pain and functional disability in Arabic-speaking adults with nonspecific spinal pain.
The main questions it aims to answer are:
- Is the Arabic version of the EASPS a valid instrument for evaluating spine-related pain and disability among Arabic-speaking patients?
- Is the Arabic version of the EASPS a reliable instrument with acceptable internal consistency and test-retest reliability?
Participants will:
- Complete the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS).
- Complete the Arabic version of the Short Form-36 (SF-36) questionnaire to assess construct validity.
- Participate in the cultural adaptation and validation process of the Arabic EASPS.
- A subgroup of participants will complete the Arabic EASPS again after 7 days to assess test-retest reliability.
연구 개요
상세 설명
Spinal pain, including cervical, thoracic, and lumbar pain, is one of the most common musculoskeletal disorders worldwide and is associated with significant disability, reduced quality of life, and increased healthcare utilization. Accurate assessment of spinal pain and its impact on functional activities is essential for clinical decision-making, monitoring treatment outcomes, and conducting research. Patient-reported outcome measures provide a practical and efficient method for evaluating pain severity and disability; however, the availability of culturally adapted and validated assessment tools for Arabic-speaking populations remains limited.
The Extended Aberdeen Spine Pain Scale (EASPS) is a multidimensional self-administered questionnaire designed to assess pain intensity, functional limitations, and disability related to the cervical, thoracic, and lumbar regions of the spine. The instrument has demonstrated acceptable psychometric properties in its original English version and has been culturally adapted into other languages. However, an Arabic version has not yet been developed or validated.
The purpose of this prospective observational study is to translate, culturally adapt, and evaluate the validity and reliability of the Arabic version of the Extended Aberdeen Spine Pain Scale among Arabic-speaking adults with nonspecific spinal pain. The translation and cross-cultural adaptation process will follow internationally accepted guidelines and will include forward translation, reconciliation, backward translation, expert committee review, and cognitive debriefing with representatives of the target population.
A total of 300 Arabic-speaking adults aged 18 to 45 years with nonspecific cervical, thoracic, or lumbar spinal pain will be recruited. Participants will complete the Arabic version of the EASPS and the validated Arabic version of the Short Form-36 (SF-36) Health Survey. Construct validity will be assessed by examining the relationship between EASPS scores and SF-36 outcomes. Face and content validity will be evaluated by expert panels consisting of healthcare professionals and language specialists. Exploratory factor analysis will be conducted to investigate the underlying factor structure of the questionnaire.
Reliability testing will include assessment of internal consistency using Cronbach's alpha coefficient and test-retest reliability using intraclass correlation coefficients (ICC). A subgroup of participants will complete the Arabic EASPS for a second time after a seven-day interval, provided that no significant clinical changes occur during that period.
The findings of this study are expected to provide a culturally appropriate, valid, and reliable Arabic version of the Extended Aberdeen Spine Pain Scale, facilitating the assessment of spinal pain and disability in clinical practice and research settings across Arabic-speaking populations.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Giza, 이집트
- Cairo University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adults aged 18-45 years.
- Both sexes.
- Diagnosed with nonspecific spinal pain (cervical, thoracic, or lumbar).
- Arabic is a primary spoken and written language.
- Ability to provide informed consent.
Inclusion criteria for experts:
- Their experiences aren't less than ten years or at least master's degree in physical therapy.
- Major part of their work is with the Arabic population.
- They are fluent in Arabic and English language.
- Both genders were included.
Exclusion Criteria:
- History of spinal surgery.
- Neurological deficits or serious pathology (e.g., cancer, infection).
- Cognitive impairment or psychiatric conditions preventing questionnaire completion.
- Undergoing active treatment changes during test-retest interval.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Arabic-Speaking Adults with Nonspecific Spinal Pain
This cohort consists of Arabic-speaking adults aged 18 to 45 years diagnosed with nonspecific spinal pain affecting the cervical, thoracic, and/or lumbar regions of the spine.
Participants will complete the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) and the Arabic version of the SF-36 questionnaire.
A subgroup of participants will complete the Arabic EASPS again after 7 days to evaluate test-retest reliability as part of the psychometric validation process.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Arabic Version of the Extended Aberdeen Spine Pain Scale (EASPS)
기간: Baseline and 7 Days
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The Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) will be used to assess spine-related pain and disability.
The questionnaire contains 30 items covering pain, physical impairment, and functional disability.
Responses are summed and converted to a score ranging from 0 to 100, with higher scores indicating greater disability.
The measure will be used to evaluate the validity and reliability of the Arabic version of the instrument.
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Baseline and 7 Days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Arabic Version of the Short Form-36 Health Survey (SF-36)
기간: Baseline
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The Arabic version of the SF-36 questionnaire will be administered to assess construct validity of the Arabic EASPS.
The SF-36 evaluates health-related quality of life across physical and mental health domains.
The SF-36 yields domain scores ranging from 0 to 100, with higher scores indicating better health status and functioning.
Correlations between SF-36 scores and EASPS scores will be analyzed to determine construct validity.
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Baseline
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공동 작업자 및 조사자
스폰서
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
기타 연구 ID 번호
- P.T.REC/012/006036
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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