Ignite Creation Date:
2025-12-18 @ 9:37 AM
Ignite Modification Date:
2025-12-18 @ 9:37 AM
Study NCT ID:
NCT06666478
Status:
None
Last Update Posted:
2024-10-30 00:00:00
First Post:
2024-10-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise While at Work Alleviates Work-Related Pain and Improves Mood in Workers
Sponsor:
None
Organization:
Study Overview
Official Title:
The Effectiveness of a Specific Exercise Program in Alleviating Work-Related Pain and Improving Mood in Various Occupational Populations
Status:
None
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Participants' Inclusion and Exclusion Criteria
The study was announced at a public hospital in Northern Greece and within private companies, as described below. Inclusion criteria required participants to be healthcare employees, office employees (both remote and daily commuting workers), or workers involved in manual cargo handling, heavy industry, or agricultural work. Eligible participants were aged up to 67 years, had more than one year of experience in their current position, and had a diagnosis of work-related nonspecific musculoskeletal pain. Healthcare employees were defined as those working in hospital settings, specifically as surgeons or nurses. Office employees were defined as individuals performing administrative tasks in a seated position, such as secretaries, clerks, or typists.
For the purposes of this study, "nonspecific musculoskeletal pain" was defined as pain that cannot be attributed to fractures, direct trauma, or systemic disease, and for which there is no evidence of root compression requiring surgical treatment.
Description of the Exercise Protocol
The exercise protocol begins in a seated position with spinal mobility exercises that mobilize the hips, lumbar spine, thoracic spine, and cervical spine, alongside progressive activation of the peripheral joints in the upper limbs. This is followed by multiaxial functional exercises for the trunk and upper limbs, incorporating various movements (e.g., lateral bending and twisting) that simulate positions assumed by employees during work tasks.
The subsequent exercises are performed in a standing position, focusing on stretching and mobilizing the joints and nervous tissue to promote relaxation and release. Emphasis is placed on coordination, fluid movement, and controlled breathing to help participants develop and maintain core stability while working. These principles are essential for individuals frequently exposed to physical stressors, enabling them to improve movement quality-specifically, smoothness, rhythm, and appropriate speed-thereby enhancing effectiveness with minimal exertion.
All exercises are conducted with full, rhythmic breathing: inhaling to oxygenate body tissues and exhaling to eliminate cellular waste. At the end of each session, participants engage in a specific diaphragmatic breathing relaxation technique.
Assessment Tools
Visual Analogue Scale (VAS) Pain intensity was assessed using the Visual Analogue Scale (VAS). Using a ruler, the score is determined by measuring the distance in millimeters on a 10-cm line between "no pain" and "severe pain," with a higher score indicating greater pain intensity.
Feeling Scale (FS) The Feeling Scale (FS) is an 11-point bipolar rating scale measuring current mood on a valence dimension. The scale ranges from -5 ("very bad") to +5 ("very good"), with intermediate points such as -3 ("bad"), -1 ("fairly bad"), 0 ("neutral"), +1 ("fairly good"), and +3 ("good").
Fatigue Scale The Fatigue Scale is an 11-item measure that distinguishes between mental fatigue (four items) and physical fatigue (seven items), capturing cognitive difficulties and physical tiredness, respectively. This scale uses a five-point rating system (1 = "never" to 5 = "always") and can produce a total fatigue score. It has demonstrated reliability, validity, and sensitivity to treatment changes.
Greek Modified Neck Disability Index (NDI) The Neck Disability Index (NDI) was used to measure functional disability due to neck pain. Widely regarded as the most valid tool for assessing neck pain-related disability, it consists of 10 questions covering the impact of neck pain on daily activities, including personal care, lifting, reading, working, driving, sleeping, and recreation, as well as on pain itself (e.g., intensity, headache, concentration). Each item is scored from 0 to 5, producing a total score ranging from 0 (no disability) to 50 (maximum disability). Higher scores indicate greater pain and functional disability. The Greek version of the NDI has high validity (Cronbach's alpha: 0.85) and excellent reliability (ICC: 0.93).
36-Item Short Form Health Survey (SF-36) The SF-36 is a widely used questionnaire assessing overall health and quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, social functioning, bodily pain, general health perceptions, vitality, and mental health. The SF-36 provides scores for each domain and summary scores for physical and mental health, and is commonly used in both clinical and research settings to evaluate patient-reported outcomes.
Modified Fingertip-to-Floor Distance Test This simple clinical test assesses spinal mobility, particularly in the lower back and hamstrings. The distance between the fingertips and the floor is measured as the participant bends forward as far as possible with knees straight and feet together. This test evaluates flexibility, range of motion, and any movement restrictions.
Lateral Spinal Flexion Lateral Spinal Flexion is a clinical assessment used to measure spinal range of motion during sideways bending. The test evaluates the ability to flex the spine laterally in both directions, helping identify any movement restrictions, imbalances, or asymmetries.
The study was announced at a public hospital in Northern Greece and within private companies, as described below. Inclusion criteria required participants to be healthcare employees, office employees (both remote and daily commuting workers), or workers involved in manual cargo handling, heavy industry, or agricultural work. Eligible participants were aged up to 67 years, had more than one year of experience in their current position, and had a diagnosis of work-related nonspecific musculoskeletal pain. Healthcare employees were defined as those working in hospital settings, specifically as surgeons or nurses. Office employees were defined as individuals performing administrative tasks in a seated position, such as secretaries, clerks, or typists.
For the purposes of this study, "nonspecific musculoskeletal pain" was defined as pain that cannot be attributed to fractures, direct trauma, or systemic disease, and for which there is no evidence of root compression requiring surgical treatment.
Description of the Exercise Protocol
The exercise protocol begins in a seated position with spinal mobility exercises that mobilize the hips, lumbar spine, thoracic spine, and cervical spine, alongside progressive activation of the peripheral joints in the upper limbs. This is followed by multiaxial functional exercises for the trunk and upper limbs, incorporating various movements (e.g., lateral bending and twisting) that simulate positions assumed by employees during work tasks.
The subsequent exercises are performed in a standing position, focusing on stretching and mobilizing the joints and nervous tissue to promote relaxation and release. Emphasis is placed on coordination, fluid movement, and controlled breathing to help participants develop and maintain core stability while working. These principles are essential for individuals frequently exposed to physical stressors, enabling them to improve movement quality-specifically, smoothness, rhythm, and appropriate speed-thereby enhancing effectiveness with minimal exertion.
All exercises are conducted with full, rhythmic breathing: inhaling to oxygenate body tissues and exhaling to eliminate cellular waste. At the end of each session, participants engage in a specific diaphragmatic breathing relaxation technique.
Assessment Tools
Visual Analogue Scale (VAS) Pain intensity was assessed using the Visual Analogue Scale (VAS). Using a ruler, the score is determined by measuring the distance in millimeters on a 10-cm line between "no pain" and "severe pain," with a higher score indicating greater pain intensity.
Feeling Scale (FS) The Feeling Scale (FS) is an 11-point bipolar rating scale measuring current mood on a valence dimension. The scale ranges from -5 ("very bad") to +5 ("very good"), with intermediate points such as -3 ("bad"), -1 ("fairly bad"), 0 ("neutral"), +1 ("fairly good"), and +3 ("good").
Fatigue Scale The Fatigue Scale is an 11-item measure that distinguishes between mental fatigue (four items) and physical fatigue (seven items), capturing cognitive difficulties and physical tiredness, respectively. This scale uses a five-point rating system (1 = "never" to 5 = "always") and can produce a total fatigue score. It has demonstrated reliability, validity, and sensitivity to treatment changes.
Greek Modified Neck Disability Index (NDI) The Neck Disability Index (NDI) was used to measure functional disability due to neck pain. Widely regarded as the most valid tool for assessing neck pain-related disability, it consists of 10 questions covering the impact of neck pain on daily activities, including personal care, lifting, reading, working, driving, sleeping, and recreation, as well as on pain itself (e.g., intensity, headache, concentration). Each item is scored from 0 to 5, producing a total score ranging from 0 (no disability) to 50 (maximum disability). Higher scores indicate greater pain and functional disability. The Greek version of the NDI has high validity (Cronbach's alpha: 0.85) and excellent reliability (ICC: 0.93).
36-Item Short Form Health Survey (SF-36) The SF-36 is a widely used questionnaire assessing overall health and quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, social functioning, bodily pain, general health perceptions, vitality, and mental health. The SF-36 provides scores for each domain and summary scores for physical and mental health, and is commonly used in both clinical and research settings to evaluate patient-reported outcomes.
Modified Fingertip-to-Floor Distance Test This simple clinical test assesses spinal mobility, particularly in the lower back and hamstrings. The distance between the fingertips and the floor is measured as the participant bends forward as far as possible with knees straight and feet together. This test evaluates flexibility, range of motion, and any movement restrictions.
Lateral Spinal Flexion Lateral Spinal Flexion is a clinical assessment used to measure spinal range of motion during sideways bending. The test evaluates the ability to flex the spine laterally in both directions, helping identify any movement restrictions, imbalances, or asymmetries.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: