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Completed

NCT Number: NCT05827185

Effects of Workstation Ergonomics and Physiotherapy in Cervicogenic Headache.

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.

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Key information

Conditions

Cervicogenic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Traumatic Headache

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ergonomic modifications

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

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 and Physiotherapy

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.

Patient education

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.

Primary outcomes

  1. CgH frequency

    Time frame: 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

  2. CgH frequency

    Time frame: 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

  3. CgH frequency

    Time frame: 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

  4. CgH frequency

    Time frame: 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

Secondary outcomes

  1. CgH pain intensity

    Time frame: Baseline

    The pain intensity of CgH was assessed using an 11-point numerical pain rating scale (NPRS). Patients rated their typical level of pain status during the previous week on a 10 cm horizontal line, with one end 0 representing "no pain" and the other end 10 representing "worst pain imaginable.

  2. CgH pain intensity

    Time frame: 4 weeks

    The pain intensity of CgH was assessed using an 11-point numerical pain rating scale (NPRS). Patients rated their typical level of pain status during the previous week on a 10 cm horizontal line, with one end 0 representing "no pain" and the other end 10 representing "worst pain imaginable.

  3. CgH pain intensity

    Time frame: 8 weeks

    The pain intensity of CgH was assessed using an 11-point numerical pain rating scale (NPRS). Patients rated their typical level of pain status during the previous week on a 10 cm horizontal line, with one end 0 representing "no pain" and the other end 10 representing "worst pain imaginable.

  4. CgH pain intensity

    Time frame: 6 months

    The pain intensity of CgH was assessed using an 11-point numerical pain rating scale (NPRS). Patients rated their typical level of pain status during the previous week on a 10 cm horizontal line, with one end 0 representing "no pain" and the other end 10 representing "worst pain imaginable.

  5. CgH disability

    Time frame: Baseline

    The Headache Impact Test (HIT) questionnaire is a valid and reliable instrument to assess the level of disability in CgH patients. It consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The score categories are no or mild disability (49 or less), moderate disability (50-55), severe disability (56-59), and complete disability (60-78).

  6. CgH disability

    Time frame: 4 weeks

    The Headache Impact Test (HIT) questionnaire is a valid and reliable instrument to assess the level of disability in CgH patients. It consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The score categories are no or mild disability (49 or less), moderate disability (50-55), severe disability (56-59), and complete disability (60-78).

  7. CgH disability

    Time frame: 8 weeks

    The Headache Impact Test (HIT) questionnaire is a valid and reliable instrument to assess the level of disability in CgH patients. It consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The score categories are no or mild disability (49 or less), moderate disability (50-55), severe disability (56-59), and complete disability (60-78).

  8. CgH disability

    Time frame: 6 months

    The Headache Impact Test (HIT) questionnaire is a valid and reliable instrument to assess the level of disability in CgH patients. It consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The score categories are no or mild disability (49 or less), moderate disability (50-55), severe disability (56-59), and complete disability (60-78).

  9. Cervical flexion-rotation test (FRT)

    Time frame: Baseline

    The cervical flexion-rotation test is done with the patient in a supine lying position. The therapist passively maintains the patient's neck into full flexion to relax the structures of the middle and lower cervical spine, then the patient's head is passively rotated in each direction while the flexed position is maintained and the range of motion is measured.

  10. Cervical flexion-rotation test (FRT)

    Time frame: 4 weeks

    The cervical flexion-rotation test is done with the patient in a supine lying position. The therapist passively maintains the patient's neck into full flexion to relax the structures of the middle and lower cervical spine, then the patient's head is passively rotated in each direction while the flexed position is maintained and the range of motion is measured.

  11. Cervical flexion-rotation test (FRT)

    Time frame: 8 weeks

    The cervical flexion-rotation test is done with the patient in a supine lying position. The therapist passively maintains the patient's neck into full flexion to relax the structures of the middle and lower cervical spine, then the patient's head is passively rotated in each direction while the flexed position is maintained and the range of motion is measured.

  12. Cervical flexion-rotation test (FRT)

    Time frame: 6 months

    The cervical flexion-rotation test is done with the patient in a supine lying position. The therapist passively maintains the patient's neck into full flexion to relax the structures of the middle and lower cervical spine, then the patient's head is passively rotated in each direction while the flexed position is maintained and the range of motion is measured.

  13. Work ability

    Time frame: Baseline

    It was measured by Work Ability Index (WAI), which consists of 7 items such as: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. It ranges from 7 to 49 points and 4 categories such as; poor (7 - 27), moderate (28 -36), good (37-43) and excellent (44-49).

  14. Work ability

    Time frame: 4 weeks

    It was measured by Work Ability Index (WAI), which consists of 7 items such as: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. It ranges from 7 to 49 points and 4 categories such as; poor (7 - 27), moderate (28 -36), good (37-43) and excellent (44-49).

  15. Work ability

    Time frame: 8 weeks

    It was measured by Work Ability Index (WAI), which consists of 7 items such as: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. It ranges from 7 to 49 points and 4 categories such as; poor (7 - 27), moderate (28 -36), good (37-43) and excellent (44-49).

  16. Work ability

    Time frame: 6 months

    It was measured by Work Ability Index (WAI), which consists of 7 items such as: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. It ranges from 7 to 49 points and 4 categories such as; poor (7 - 27), moderate (28 -36), good (37-43) and excellent (44-49).

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2023
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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