- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07576556
Mindfulness Plus Supervised Rehabilitation vs Supervised Rehabilitation Alone for Chronic Neck Pain in Office Workers
Effect of Mindfulness Combined With Supervised Rehabilitation Versus Supervised Rehabilitation Alone in Office Workers With Chronic Neck Pain: Protocol for a Randomized Controlled Trial
The goal of this clinical trial is to learn if adding mindfulness to supervised rehabilitation exercises improves outcomes in office workers with chronic neck pain. It will also evaluate the impact of this combined approach on psychosocial factors and quality of life. The main questions it aims to answer are:
Does mindfulness combined with supervised exercises reduce neck pain intensity more than supervised exercises alone? Does the combined intervention improve neck-related disability, psychosocial outcomes, and quality of life?
Researchers will compare a mindfulness-based intervention plus supervised rehabilitation exercises to supervised rehabilitation exercises alone to determine whether the combined approach provides additional benefit.
Participants will:
Be randomly assigned to receive either mindfulness plus supervised exercises or supervised exercises alone for 8 weeks Attend weekly 60-minute mindfulness sessions (experimental group only) and twice-weekly supervised exercise sessions Undergo assessments at the beginning and at the end of the intervention period
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Amr Chaabeni, MD
- 전화번호: +21626729316
- 이메일: amrch97@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Office workers aged 18 years or older
- diagnosed with chronic neck pain for more the three months
Exclusion Criteria:
- history of neck surgery
- history of cervical trauma
- history of neurological disorders affecting the neck or upper extremities
- currently receiving other treatments for neck pain, such as injections or surgical interventions
- Participants with significant psychiatric disorders that could interfere with study participation or adherence to the intervention
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: Mindfulness arm
Participants in the intervention group will follow an 8-week supervised program combining mindfulness training and therapeutic exercise.
The intervention includes one weekly 60-minute mindfulness session and two supervised exercise sessions (each lasting 30 minutes), delivered by a trained professional according to a standardized protocol.
Mindfulness sessions will be conducted in small groups and incorporate structured practices including mindful breathing, body scanning, guided imagery, and relaxation techniques.
Mindful breathing focuses on sustained, non-judgmental attention to the breath to enhance present-moment awareness and modulate pain perception.
Body scanning involves systematic attention to body regions to increase awareness of sensations and tension.
Guided imagery and relaxation techniques (e.g., progressive muscle relaxation, meditation) aim to promote relaxation and reduce pain-related distress
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Mindfulness training incorporates structured practices such as mindful breathing, body scanning, guided imagery, and relaxation techniques.
Mindful breathing focuses on sustained, non-judgmental attention to the breath to enhance present-moment awareness and modulate pain perception.
Body scanning involves systematic attention to body regions to increase awareness of physical sensations and tension.
Guided imagery and relaxation techniques, including progressive muscle relaxation and meditation, aim to promote relaxation and reduce pain-related distress.
다른 이름들:
The program will focus on standardized stretching, strengthening, and postural exercises commonly prescribed in routine musculoskeletal rehabilitation. Stretching exercises will target the cervical region and will include neck flexion, extension, and lateral flexion stretches, each performed in a seated upright position, held for 30 seconds, and repeated three times per direction. Strengthening exercises will emphasize cervical muscle activation and endurance and will include neck retraction exercises (chin pull-back) and isometric neck strengthening performed against manual resistance in flexion, extension, and lateral directions, with standardized hold times and repetitions. Postural exercises will focus on cervical and scapular alignment and will include chin tucks and shoulder blade squeezes, performed with controlled holds and repeated sets.
다른 이름들:
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활성 비교기: Control arm
Participants in the control group will follow an 8-week supervised conventional exercise program consisting of two sessions per week, each lasting 30 minutes, delivered according to a standardized protocol.
The program includes stretching, strengthening, and postural exercises commonly used in musculoskeletal rehabilitation.
Stretching targets the cervical region (flexion, extension, lateral flexion), with each stretch held for 30 seconds and repeated three times.
Strengthening focuses on cervical muscle activation and endurance through neck retraction and isometric exercises against manual resistance in multiple directions.
Postural exercises emphasize cervical and scapular alignment, including chin tucks and scapular retraction performed with controlled holds.
All sessions are supervised, and participants continue their usual occupational activities.
|
The program will focus on standardized stretching, strengthening, and postural exercises commonly prescribed in routine musculoskeletal rehabilitation. Stretching exercises will target the cervical region and will include neck flexion, extension, and lateral flexion stretches, each performed in a seated upright position, held for 30 seconds, and repeated three times per direction. Strengthening exercises will emphasize cervical muscle activation and endurance and will include neck retraction exercises (chin pull-back) and isometric neck strengthening performed against manual resistance in flexion, extension, and lateral directions, with standardized hold times and repetitions. Postural exercises will focus on cervical and scapular alignment and will include chin tucks and shoulder blade squeezes, performed with controlled holds and repeated sets.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Neck pain using the VAS
기간: at participant enrollment (baseline) and ending immediately after the 8-week intervention
|
Neck pain intensity is the primary outcome, assessed using the Visual Analogue Scale (VAS).
Participants rate their pain on a 100-mm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (100), with higher scores indicating greater pain intensity.
|
at participant enrollment (baseline) and ending immediately after the 8-week intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Neck Disability Index (NDI)
기간: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The NDI consists of 10 items (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation), each scored from 0 to 5, yielding a total score between 0 and 50.
Higher scores indicate greater disability.
the NDI have a strong internal consistency, high test-retest reliability, and sensitivity to clinical change.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
|
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Fear of movement using the Tampa Scale for Kinesiophobia
기간: at participant enrollment (baseline) and ending immediately after the 8-week intervention
|
The Tampa Scale for Kinesiophobia (TSK) will be employed to evaluate participants' fear of movement and re-injury.
The scale consists of 17 items, each rated from 1 to 4, with higher scores indicating greater kinesiophobia.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Pain catastrophizing
기간: at participant enrollment (baseline) and ending immediately after the 8-week intervention
|
Catastrophic thinking will be assessed with the Pain Catastrophizing Scale (PCS).
This instrument evaluates the extent to which individuals engage in catastrophic thoughts related to their pain.
it consists of 13 items, each ranging from 0 (not at all) to 4 (all the time).
Higher scores indicate greater levels of catastrophizing.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Perceived stress
기간: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The Perceived Stress Scale (PSS) evaluates the perception of stress in individuals and is essential for understanding how mindfulness interventions may reduce stress levels among participants.
the PSS measures perceived stress over the past month.
it includes 10 items each rated from 0 (never) to 4 (very often).
Higher scores indicate greater perceived stress.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADs)
기간: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The HADS is a validated instrument widely used in both hospital and general populations to evaluate psychological distress, which is particularly relevant in the context of chronic pain.
It consists of 14 items divided into two subscales, anxiety and depression, with 7 items each from 0 to 3. higher subscale scores reflect more severe symptoms of anxiety or depression.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
기간: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The PSQI is a validated self-report instrument that evaluates sleep quality and disturbances over the past month.
It comprises 19 items with a score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Health-related quality of life using the SF-12
기간: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The SF-12 evaluates overall well-being by capturing both physical and mental health dimensions.
It provides two standardized summary scores: the Physical Component Score (PCS) and the Mental Component Score (MCS), each range from 0 to 100, with higher scores indicating better health status.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- MINDEX-NECK-RCT-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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