Effects of Workstation Ergonomics and Physiotherapy in Cervicogenic Headache.

Cervicogenic Headache Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827185
• Other study ID #: RHPT/019/082
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: Prince Sattam Bin Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Saudi Arabia	Dr. Gopal Nambi	Al Kharj	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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