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Mindfulness Plus Supervised Rehabilitation vs Supervised Rehabilitation Alone for Chronic Neck Pain in Office Workers

2026年5月2日 更新者:Anis Jellad、University of Monastir

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

研究概览

研究类型

介入性

注册 (估计的)

48

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的: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
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.
其他名称:
  • 认知行为疗法
  • 行为疗法

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.

其他名称:
  • 复原
有源比较器: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.

其他名称:
  • 复原

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Neck pain using the VAS
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Neck Disability Index (NDI)
大体时间:at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Fear of movement using the Tampa Scale for Kinesiophobia
大体时间: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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Pain catastrophizing
大体时间: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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Perceived stress
大体时间:at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADs)
大体时间:at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
大体时间:at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Health-related quality of life using the SF-12
大体时间:at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年5月2日

首先提交符合 QC 标准的

2026年5月2日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月8日

上次提交的符合 QC 标准的更新

2026年5月2日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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