Effects of Workstation Ergonomics and Physiotherapy in Cervicogenic Headache.

NCT ID: NCT05827185

Last Updated: 2023-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervicogenic Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study includes ergonomic modifications group (EMG; n=24), physiotherapy group (PTG; n=24), and ergonomic modifications combined with physiotherapy group (EPG; n=24) and, control group (CNG; n=24)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Ergonomic modifications group (EMG)

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.

Group Type EXPERIMENTAL

Ergonomic modifications

Intervention Type BIOLOGICAL

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 (7 items related to office chair, 9 items related to office desk, 8 items related to keyboard and mouse, 5 items related to computer screen, 3 items related to telephone and 5 items related to the office environment -) and it has a good reliability and validity. 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.

Physiotherapy group (PTG)

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.

Group Type EXPERIMENTAL

Physiotherapy

Intervention Type BIOLOGICAL

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. To perform the C1-C2 cervical spine manipulation (CSM) the participant was instructed to lie in a face-up position with upper and lower extremities kept aside relaxed. The head was kept in a neutral position and the treating therapist stands at the patient's head side and holds the chin of the patient with the right side hand. The therapist left hand holds the posterior aspect of the head and does two to three free rotatory movements. Afterwards, the therapist did HVLAT technique in either the right or left direction based upon the symptoms informed by the patient.

Ergonomic modifications combined with physiotherapy group (EPG)

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.

Group Type EXPERIMENTAL

Ergonomic modifications and Physiotherapy

Intervention Type BIOLOGICAL

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. After assessment required modifications were done in the chair, desk, keyboard, mouse, computer screen, telephone and the office environment.

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.

Control group (CNG)

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.

Group Type SHAM_COMPARATOR

Patient education

Intervention Type BIOLOGICAL

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.

Interventions

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Ergonomic modifications

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 (7 items related to office chair, 9 items related to office desk, 8 items related to keyboard and mouse, 5 items related to computer screen, 3 items related to telephone and 5 items related to the office environment -) and it has a good reliability and validity. 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.

Intervention Type BIOLOGICAL

Physiotherapy

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. To perform the C1-C2 cervical spine manipulation (CSM) the participant was instructed to lie in a face-up position with upper and lower extremities kept aside relaxed. The head was kept in a neutral position and the treating therapist stands at the patient's head side and holds the chin of the patient with the right side hand. The therapist left hand holds the posterior aspect of the head and does two to three free rotatory movements. Afterwards, the therapist did HVLAT technique in either the right or left direction based upon the symptoms informed by the patient.

Intervention Type BIOLOGICAL

Ergonomic modifications and Physiotherapy

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. After assessment required modifications were done in the chair, desk, keyboard, mouse, computer screen, telephone and the office environment.

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.

Intervention Type BIOLOGICAL

Patient education

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Gopal Nambi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gopal Nambi, PhD

Role: PRINCIPAL_INVESTIGATOR

Prince Sattam bin Abdulaziz University, Al Kharj, Saudi Arabia

Locations

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Dr. Gopal Nambi

Al Kharj, Riyadh Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Nambi G, Alghadier M, Pakkir Mohamed SH, Vellaiyan A, Ebrahim EE, Sobeh DE, Kashoo FZ, Albarakati AJA, Alshahrani NA, Eswaramoorthi V. 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. Front Public Health. 2024 Nov 28;12:1438591. doi: 10.3389/fpubh.2024.1438591. eCollection 2024.

Reference Type DERIVED
PMID: 39697289 (View on PubMed)

Other Identifiers

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RHPT/019/082

Identifier Type: -

Identifier Source: org_study_id

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