Musculoskeletal PainNCT06666478
Exercise While at Work Alleviates Work-Related Pain and Improves Mood in Workers
A study testing Exercise protocol at workspace in people with Musculoskeletal Pain, run by Anastasia Beneka at 1 site in Greece.
Trial summary
The goal of this clinical trial is to learn if specific exercise protocol while at work works to treat musculoskeletal pain such as neck pain, back pain, or shoulders' pain in adults workers. It will also learn about the effectiveness of this exercise protocol in improving their mood while working. Read more about this study
- Who is it for?
- Ages 19 to 67 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Exercise protocol at workspace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 1 siteGreece
- Study dates
- 8 Jan 2024to 15 Oct 2024
- Phase
- Interventional
- 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 19 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-67
- experienced either persistent or recurrent pain or discomfort in the neck and/or upper back (back) and/or lower back and/or shoulders at least twice during the three months prior to the start of the study
- The average intensity of pain/discomfort over the last three months, measured on a ten-point numerical pain scale, needed to be between 3-7, where 0 corresponds to "no pain" and 10 corresponds to "unbearable pain."
- Job requiring long hours of sedentary work using computers or other technologies
- Job requiring long hours of bending and lifting weights
- Job requiring long hours in a standing position
Show all 9Show fewer
- Employment as nurses, doctors, or surgeons
- Manual labor in distribution warehouses
- Manual labor in heavy industry
Who cannot join
- significant coexisting respiratory, cardiovascular, vascular, oncological, neoplastic, rheumatological, neurological, or psychiatric disease, severe metabolic disorders, or neuromuscular disorders
- any health issues that prevented them from exercising or had received medical recommendations to exercise only under supervision
- if they were taking prescribed medication or undergoing any treatment (e.g., physical therapy) related to their discomfort in the spine or had another serious orthopedic issue
- individuals with a history of spinal surgery or those who had undergone any other major surgery in the past year
- Those with significant herniated discs, severe scoliosis, severe spondylolisthesis, ankylosing spondylitis, congenital spinal deformities, whiplash injuries, sciatica with pain intensity equal to or greater than that in the lower back, and upper limb pain with intensity equal to or greater than that in the neck were also excluded.
- Individuals with phlebitis or those who were pregnant
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physical Education, Sport Science and Occupational Therapy
Komotini, 69132
About this study
Official title: The Effectiveness of a Specific Exercise Program in Alleviating Work-Related Pain and Improving Mood in Various Occupational Populations
The goal of this clinical trial is to learn if specific exercise protocol while at work works to treat musculoskeletal pain such as neck pain, back pain, or shoulders' pain in adults workers. It will also learn about the effectiveness of this exercise protocol in improving their mood while working. The main questions it aims to answer are:
- Does exercise while at work help in alleviating pain due to physical exertion?
- Does exercise while at work help in improving mood in workers? Researchers will compare the exercise group to a control group (no guided exercise during the intervention period) to see if exercise works to treat pain due to physical exertion in various working populations.
Read more
Participants will:
- Apply a specific exercise protocol adjusted to their workplace and their job's profile for 2 months with a frequency of 3 times per week
- Fill in questionnaires about their pain, mood state, fatigue scale, functional activities level (SF36), Neck disability Index at the beginning of the study, the end of the study and 2 weeks after the end.
Read the detailed description
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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Exercise protocol at workspace
- Keywords
- exercise at workspace
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise protocol at workspaceOther
The exercise protocol at Workspace begins in a sitting position with spinal mobility exercises that mobilize the hips, lumbar spine, thoracic spine, and cervical spine, accompanied by progressive activation of the peripheral joints in the upper limbs. This is followed by multiaxial functional exercises for the trunk and upper limbs, which combine various movements (e.g., lateral bending and twisting) that simulate the positions employees assume while working.
Subsequently, exercises are performed in an upright position, focusing on stretching and mobilizing the joints and nervous tissue to promote relaxation and release. Coordination, fluid movement, and controlled breathing are emphasized to help workers develop and maintain a stable core while on the job. These principles are essential for workers who are frequently exposed to stressors and physical exertion, as they seek to improve the quality of their movements-namely, smoothness, rhythm, and appropriate speed-while at work.
| Study group | Role | What they receive |
|---|---|---|
| Exercise protocol at workspace | Experimental | The exercise protocol at Workspace begins in a sitting position with spinal mobility exercises that mobilize the hips, lumbar spine, thoracic spine, and cervical spine, accompanied by progressive activation of the peripheral joints in the upper limbs. This is followed by multiaxial functional exercises for the trunk and upper limbs, which combine various movements (e.g., lateral bending and twisting) that simulate the positions employees assume while working.
Subsequently, exercises are performed in an upright position, focusing on stretching and mobilizing the joints and nervous tissue to promote relaxation and release. Coordination, fluid movement, and controlled breathing are emphasized to help workers develop and maintain a stable core while on the job. These principles are essential for workers who are frequently exposed to stressors and physical exertion, as they seek to improve the quality of their movements-namely, smoothness, rhythm, and appropriate speed-while at work. Receives: Other: Exercise protocol at workspace |
| Control group | No intervention | Description: Control group. No exercise intervention. A printed document containing general guidelines for pain management and prevention of pain will be provided, in accordance with international guidelines for non-pharmacological interventions in the prevention of chronic non-specific spinal pain, along with recommended exercises for posture improvement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
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.
Measured: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
Feeling Scale
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").
Measured: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
Neck Disability Index
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).
Measured: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
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.
Measured: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
Short-Form Health Survey 36 - 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.
Measured: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
Modified Fingertip-to-Floor Distance Test, Spinal Lateral Flexion
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.
Measured: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
Lateral Spinal Flexion Range of Motion
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.
Measured: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start8 Jan 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anastasia Beneka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anastasia Beneka, Democritus University of Thrace
- Investigators
- Anastasia Gr Beneka, Professor, Principal investigator, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666478
- Sponsor's protocol ID
- 15010/133
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared with anybody because of the Companies/Organizations GDPR policy. They are very sensitive with the GDPR.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Specific Exercise Program in Alleviating Work-Related Pain and Improving Mood in Various Occupational Populations
- ClinicalTrials.gov ID
- NCT06666478
- Acronym / sponsor ID
- 15010/133
- Conditions
- Musculoskeletal Pain
- Keywords
- exercise at workspace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- Anastasia BenekaUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 30 Oct 2024 (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.
The goal of this clinical trial is to learn if specific exercise protocol while at work works to treat musculoskeletal pain such as neck pain, back pain, or shoulders' pain in adults workers. It will also learn about the effectiveness of this exercise protocol in improving their mood while working. The main questions it aims to answer are:
- Does exercise while at work help in alleviating pain due to physical exertion?
- Does exercise while at work help in improving mood in workers? Researchers will compare the exercise group to a control group (no guided exercise during the intervention period) to see if exercise works to treat pain due to physical exertion in various working populations.
Participants will:
- Apply a specific exercise protocol adjusted to their workplace and their job's profile for 2 months with a frequency of 3 times per week
- Fill in questionnaires about their pain, mood state, fatigue scale, functional activities level (SF36), Neck disability Index at the beginning of the study, the end of the study and 2 weeks after the end.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise protocol at workspace | Experimental | Other: Exercise protocol at workspaceThe exercise protocol at Workspace begins in a sitting position with spinal mobility exercises that mobilize the hips, lumbar spine, thoracic spine, and cervical spine, accompanied by progressive activation of the peripheral joints in the upper limbs. This is followed by multiaxial functional exercises for the trunk and upper limbs, which combine various movements (e.g., lateral bending and twisting) that simulate the positions employees assume while working. Subsequently, exercises are performed in an upright position, focusing on stretching and mobilizing the joints and nervous tissue to promote relaxation and release. Coordination, fluid movement, and controlled breathing are emphasized to help workers develop and maintain a stable core while on the job. These principles are essential for workers who are frequently exposed to stressors and physical exertion, as they seek to improve the quality of their movements-namely, smoothness, rhythm, and appropriate speed-while at work. |
| Control group | No intervention | –Description: Control group. No exercise intervention. A printed document containing general guidelines for pain management and prevention of pain will be provided, in accordance with international guidelines for non-pharmacological interventions in the prevention of chronic non-specific spinal pain, along with recommended exercises for posture improvement. |
Who may qualify
- Ages
- 19 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 19-67
- experienced either persistent or recurrent pain or discomfort in the neck and/or upper back (back) and/or lower back and/or shoulders at least twice during the three months prior to the start of the study
- The average intensity of pain/discomfort over the last three months, measured on a ten-point numerical pain scale, needed to be between 3-7, where 0 corresponds to "no pain" and 10 corresponds to "unbearable pain."
- Job requiring long hours of sedentary work using computers or other technologies
- Job requiring long hours of bending and lifting weights
Key exclusion criteria (6 listed)
- significant coexisting respiratory, cardiovascular, vascular, oncological, neoplastic, rheumatological, neurological, or psychiatric disease, severe metabolic disorders, or neuromuscular disorders
- any health issues that prevented them from exercising or had received medical recommendations to exercise only under supervision
- if they were taking prescribed medication or undergoing any treatment (e.g., physical therapy) related to their discomfort in the spine or had another serious orthopedic issue
- individuals with a history of spinal surgery or those who had undergone any other major surgery in the past year
- Those with significant herniated discs, severe scoliosis, severe spondylolisthesis, ankylosing spondylitis, congenital spinal deformities, whiplash injuries, sciatica with pain intensity equal to or greater than that in the lower back, and upper limb pain with intensity equal to or greater than that in the neck were also excluded.
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 |
|---|---|---|
| Exercise protocol at workspaceThe exercise protocol at Workspace begins in a sitting position with spinal mobility exercises that mobilize the hips, lumbar spine, thoracic spine, and cervical spine, accompanied by progressive activation of the peripheral joints in the upper limbs. This is followed by multiaxial functional exercises for the trunk and upper limbs, which combine various movements (e.g., lateral bending and twisting) that simulate the positions employees assume while working. Subsequently, exercises are performed in an upright position, focusing on stretching and mobilizing the joints and nervous tissue to promote relaxation and release. Coordination, fluid movement, and controlled breathing are emphasized to help workers develop and maintain a stable core while on the job. These principles are essential for workers who are frequently exposed to stressors and physical exertion, as they seek to improve the quality of their movements-namely, smoothness, rhythm, and appropriate speed-while at work. | Other | Exercise protocol at workspace |
Primary outcome
Visual Analogue Scale
Time frame: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
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
Time frame: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
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").
Neck Disability Index
Time frame: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
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).
Fatigue Scale
Time frame: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
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.
Short-Form Health Survey 36 - SF-36
Time frame: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
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, Spinal Lateral Flexion
Time frame: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
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 Range of Motion
Time frame: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment
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.
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 30 Oct 2024.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared with anybody because of the Companies/Organizations GDPR policy. They are very sensitive with the GDPR.
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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.
Anastasia Gr Beneka, Professor principal investigator
Democritus University of Thrace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise protocol at workspace in people with Musculoskeletal Pain, run by Anastasia Beneka at 1 site in Greece.
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 9 inclusion and 6 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 30 Oct 2024. 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 Greece. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Visual Analogue Scale (time frame: From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2024.