Effects of Workstation Ergonomics and Physiotherapy in Cervicogenic Headache.

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.

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.

Study Overview

• Status: Completed
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Biological: Ergonomic modifications; Biological: Physiotherapy; Biological: Ergonomic modifications and Physiotherapy; Biological: Patient education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Kharj, Riyadh, Saudi Arabia, 11942
      • Dr. Gopal Nambi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: 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.
Experimental: 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.	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.
Experimental: 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.	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.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CgH frequency	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	Baseline
CgH frequency	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 weeks
CgH frequency	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	8 weeks
CgH frequency	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CgH pain intensity	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.	Baseline
CgH pain intensity	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 weeks
CgH pain intensity	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.	8 weeks
CgH pain intensity	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.	6 months
CgH disability	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).	Baseline
CgH disability	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).	4 weeks
CgH disability	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 weeks
CgH disability	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 months
Cervical flexion-rotation test (FRT)	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.	Baseline
Cervical flexion-rotation test (FRT)	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.	4 weeks
Cervical flexion-rotation test (FRT)	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.	8 weeks
Cervical flexion-rotation test (FRT)	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.	6 months
Work ability	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).	Baseline
Work ability	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).	4 weeks
Work ability	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).	8 weeks
Work ability	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).	6 months

Collaborators and Investigators

• Sponsor: Prince Sattam Bin Abdulaziz University
• Investigators: Principal Investigator: Gopal Nambi, PhD, Prince Sattam bin Abdulaziz University, Al Kharj, Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Physiotherapy; Ergonomics; Randomized control trial; Office workers; Workstation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: RHPT/019/082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data can be obtained through contacting the corresponding author.
• IPD Sharing Time Frame: Within one week
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No