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临床试验/NCT05827185
NCT05827185已完成2 期

Combined and Isolated Effects of Workstation Ergonomics and Physiotherapy in Improving Cervicogenic Headache and Work Ability in Office Workers - A Single-blinded, Randomized Controlled Study.

Prince Sattam Bin Abdulaziz University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
96
试验地点
1
主要终点
CgH frequency

研究概览

简要总结

Cervicogenic headache (CgH) is a distinct form of headache and accounts for 17.8% of all headaches and the prevalence rate is between 0.4% and 20%. A guide to health and safety in the office handbook by common wealth of Australia (2008) suggested the ergonomic guidance and interventions for preventing and treating musculoskeletal disorder (MSD) injuries in the office workers. Also, It has been estimated that 34% of US citizens receive some sort of physiotherapy for CgH each year. However, no studies have compared and investigated the combined and individual effects of workstation ergonomics, physiotherapy and patient education for improving cervicogenic headache and work ability in office workers.

详细描述

Cervicogenic headache (CgH) is a distinct form of headache and accounts for 17.8% of all headaches and the prevalence rate is between 0.4% and 20%. A guide to health and safety in the office handbook by common wealth of Australia (2008) suggested the ergonomic guidance and interventions for preventing and treating musculoskeletal disorder (MSD) injuries in the office workers. Also, It has been estimated that 34% of US citizens receive some sort of physiotherapy for CgH each year. However, no studies have compared and investigated the combined and individual effects of workstation ergonomics, physiotherapy and patient education for improving cervicogenic headache and work ability in office workers.

Therefore, our study objective was intended to compare and investigate the combined and individual effects of workstation ergonomics, physiotherapy and patient education in improving cervicogenic headache and work ability in office workers. This randomized clinical trial hypothesized that there is a difference in primary and secondary outcome measures between workstation ergonomics, physiotherapy and patient education for improving cervicogenic headache and work ability in office workers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Because of the experimental nature of the study methodology, it was not feasible to blind the treating therapist as well as the participants included in the study. The therapists who assessed the outcome variables at baseline, 4-weeks, 8-weeks, and 6-months were blinded. Therefore, the therapist providing the treatment and the therapist measuring the data were different individuals. In addition, the outcome-measuring therapist continued to be masked to the participant's groups at all-time intervals. Also, participants were asked not to discuss their treatment details with their peers or the outcome-measuring therapist.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged between 18-60 years Working in the computer ≥ 32 hrs/week Suffering from Cervicogenic Headache (>3 months) Pain intensity ≥3 on a numerical pain rating scale (NPRS), Cervicogenic Headache resulting from pain in the neck followed by headache, Limited neck movements, Neck muscle spasm, Consent to participate in the study

排除标准

  • •Other primary headaches such as migraine and tension-type headaches (TTH), Whiplash injuries, Participants who show signs of the five 'D's' (dizziness, drop attacks, dysarthria, dysphagia, diplopia) Who have signs of the three 'N's (nystagmus, nausea, other neurological symptoms (cord compression or nerve root involvement), Contraindications to physio therapy (Congenital anomalies, tumor, degenerative and inflammatory arthritis, osteoporosis, dislocation, fractures, and steroid intake), Underwent previous head and neck surgeries, Had physiotherapy or other complementary therapies in the last three months

研究组 & 干预措施

Ergonomic modifications group (EMG)

Experimental

A blinded therapist used an observation-based ergonomics assessment check list for office workers to check the status of office environment, which usually took 40 - 45 minutes to complete. It consists of 5 domains. After assessment required modifications were done in the chair, desk, keyboard, mouse, computer screen, telephone and the office environment. Ergonomic education and instructions were also given on an individual basis as per the report of the assessment.

干预措施: Ergonomic modifications (Biological)

Physiotherapy group (PTG)

Experimental

First of all, hydro collator pack was applied over the neck region for 10 minutes to relax the muscles of the neck region. Then the therapist located the sites of abnormal changes in each vertebra and then cervical manipulation was given. If any participant reported any new red flag signs or showed no signs for manipulation, such as no pain or musculoskeletal dysfunction, then the procedure was not performed.

干预措施: Physiotherapy (Biological)

Ergonomic modifications combined with physiotherapy group (EPG)

Experimental

A blinded therapist used an observation-based ergonomics assessment check list for office workers to check the status of office environment, which usually took 40 - 45 minutes to complete. It consists of 5 domains. After assessment required modifications were done in the chair, desk, keyboard, mouse, computer screen, telephone and the office environment. Ergonomic education and instructions were also given on an individual basis as per the report of the assessment.

First of all, hydro collator pack was applied over the neck region for 10 minutes to relax the muscles of the neck region. Then the therapist located the sites of abnormal changes in each vertebra and then cervical manipulation was given. If any participant reported any new red flag signs or showed no signs for manipulation, such as no pain or musculoskeletal dysfunction, then the procedure was not performed.

干预措施: Ergonomic modifications and Physiotherapy (Biological)

Control group (CNG)

Sham Comparator

Participants in the CNG group received the patient education through an experienced physiotherapist and each session lasting for 30 minutes for 4 weeks. According to each individual patients' abilities the therapist educated them to improve the health literacy regarding the condition. The therapist educated them about the benefits of self-care activities, maintaining good posture, stay active and doing active movements and stretching muscles for preventing the health related musculoskeletal injuries at the workstation. Also, life style modifications were taught to the patients to prevent further deterioration of the condition.

干预措施: Patient education (Biological)

结局指标

主要结局

CgH frequency

时间窗: 6 months

It is a self-administered outcome variable where the patient enters his CgH pain experience in a medical log book every evening to find the number of painful days in 4-weeks

CgH frequency

时间窗: Baseline

It is a self-administered outcome variable where the patient enters his CgH pain experience in a medical log book every evening to find the number of painful days in 4-weeks

CgH frequency

时间窗: 4 weeks

It is a self-administered outcome variable where the patient enters his CgH pain experience in a medical log book every evening to find the number of painful days in 4-weeks

CgH frequency

时间窗: 8 weeks

It is a self-administered outcome variable where the patient enters his CgH pain experience in a medical log book every evening to find the number of painful days in 4-weeks

次要结局

  • CgH pain intensity(6 months)
  • CgH disability(6 months)
  • Cervical flexion-rotation test (FRT)(6 months)
  • Work ability(6 months)
  • CgH pain intensity(Baseline)
  • CgH pain intensity(4 weeks)
  • CgH pain intensity(8 weeks)
  • CgH disability(Baseline)
  • CgH disability(4 weeks)
  • CgH disability(8 weeks)
  • Cervical flexion-rotation test (FRT)(Baseline)
  • Cervical flexion-rotation test (FRT)(4 weeks)
  • Cervical flexion-rotation test (FRT)(8 weeks)
  • Work ability(Baseline)
  • Work ability(4 weeks)
  • Work ability(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gopal Nambi

Associate Professor

Prince Sattam Bin Abdulaziz University

研究点 (1)

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