Cervicogenic HeadachePhase 2NCT05827185
Effects of Workstation Ergonomics and Physiotherapy in Cervicogenic Headache.
A Phase 2 study testing Ergonomic modifications, Physiotherapy and Ergonomic modifications and Physiotherapy in people with Cervicogenic Headache, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Ergonomic modifications, Physiotherapy and Ergonomic modifications and Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2020to 28 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- Ergonomic modifications, Physiotherapy, Ergonomic modifications and Physiotherapy, Patient education
- Keywords
- Workstation, Ergonomics, Physiotherapy, Randomized control trial, Office workers
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic modificationsBiological
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.
PhysiotherapyBiological
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 PhysiotherapyBiological
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 educationBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Ergonomic modifications |
| 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. Receives: Biological: Physiotherapy |
| 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. Receives: Biological: Ergonomic modifications and Physiotherapy |
| 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. Receives: Biological: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
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.
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.
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.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 May 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gopal Nambi, Prince Sattam Bin Abdulaziz University
- Investigators
- Gopal Nambi, PhD, Principal investigator, Prince Sattam bin Abdulaziz University, Al Kharj, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827185
- Sponsor's protocol ID
- RHPT/019/082
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data can be obtained through contacting the corresponding author.
Publications
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.
PubMed 39697289
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05827185
- Acronym / sponsor ID
- RHPT/019/082
- Conditions
- Cervicogenic Headache
- Keywords
- Workstation, Ergonomics, Physiotherapy, Randomized control trial, Office workers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Ergonomic modifications group (EMG) | Experimental | Biological: Ergonomic modificationsA 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. |
| Physiotherapy group (PTG) | Experimental | Biological: PhysiotherapyFirst 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. |
| Ergonomic modifications combined with physiotherapy group (EPG) | Experimental | Biological: Ergonomic modifications and PhysiotherapyA 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. |
| Control group (CNG) | Sham comparator | Biological: Patient educationParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergonomic modificationsA 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. | Biological | Ergonomic modifications group (EMG) |
| PhysiotherapyFirst 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. | Biological | Physiotherapy group (PTG) |
| Ergonomic modifications and PhysiotherapyA 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. | Biological | Ergonomic modifications combined with physiotherapy group (EPG) |
| Patient educationParticipants 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 | Control group (CNG) |
Primary outcome
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
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
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
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
16 secondary outcomes
CgH pain intensity
Time frame: Baseline
CgH pain intensity
Time frame: 4 weeks
CgH pain intensity
Time frame: 8 weeks
CgH pain intensity
Time frame: 6 months
CgH disability
Time frame: Baseline
CgH disability
Time frame: 4 weeks
CgH disability
Time frame: 8 weeks
CgH disability
Time frame: 6 months
Cervical flexion-rotation test (FRT)
Time frame: Baseline
Cervical flexion-rotation test (FRT)
Time frame: 4 weeks
Cervical flexion-rotation test (FRT)
Time frame: 8 weeks
Cervical flexion-rotation test (FRT)
Time frame: 6 months
Work ability
Time frame: Baseline
Work ability
Time frame: 4 weeks
Work ability
Time frame: 8 weeks
Work ability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Derived from this study: PubMed 39697289Nambi 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.
- Individual participant dataSharing planned: Yes. The data can be obtained through contacting the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gopal Nambi, PhD principal investigator
Prince Sattam bin Abdulaziz University, Al Kharj, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ergonomic modifications, Physiotherapy and Ergonomic modifications and Physiotherapy in people with Cervicogenic Headache, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CgH frequency (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05827185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.