Musculoskeletal Diseases or ConditionsMUStressNCT06488547
Stress and Musculoskeletal Health in Employees
A study testing Diaphragmatic breathing (DF) and Progressive Muscle Relaxation (PMR) in people with Musculoskeletal Diseases or Conditions and Musculoskeletal Pain, run by University of Thessaly at 2 sites in Greece.
Trial summary
This study aims to evaluate potential correlation of stress as estimated by certain biological markers, namely saliva cortisol, Heart rate variability (HRV), Electromyography (EMG) with musculoskeletal system health status, and assess the impact of a stress management intervention..The intervention group will be… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases or Conditions, Musculoskeletal Pain, Musculoskeletal Health
- What is being tested?
- Diaphragmatic breathing (DF) and Progressive Muscle Relaxation (PMR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Writing and reading greek.
- Consent to provide their medical history.
- Consent to be measured with electronic devices.
Who cannot join
- Employees who are close to retirement (at least 2 years before) and those for whom any known factor may prevent them from completing the intervention (eg travel, transfer).
- Pregnancy.
- Pacemaker, history of seizures.
- Diagnosed musculoskeletal injury.
- Diagnosed diseases such as: osteoarthritis, autoimmune diseases (rheumatoid arthritis, lupus, etc.), stroke, myocardial infarction, malignant neoplasms, psychiatric disease, disability.
- Systematic reception of cortisone and anti-inflammatory treatment, up to at least three months before the intervention.
- Drugs or substances.
- Participation in another interventional program of musculoskeletal rehabilitation, physical therapy, stress management or health promotion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
The Endocrine Unit of the University of Athens
Athens, 11528
George Chrousos, Professor, +030 210 7290260 - 210 7290288, endokrinologiki@med.uoa.gr
- Recruiting
University of Thessaly
Larissa, Biopolis- Larissa, 41500
Victoria Papaxatzopoulou, Secretary, +30 2410 685702, gmed-didaktorika@med.uth.gr
Markos Sgantzos, Prof, +30 6944412554, sgantzos@med.uth.gr
About this study
Official title: Musculoskeletal Disorders and Stress Management, in Employees
This study aims to evaluate potential correlation of stress as estimated by certain biological markers, namely saliva cortisol, Heart rate variability (HRV), Electromyography (EMG) with musculoskeletal system health status, and assess the impact of a stress management intervention..The intervention group will be trained to apply two evidence based stress management techniques and they will be guided with tips and advice about musculoskeletal health.
Impact of the intervention upon measured stress related markers will be assessed.
Read the detailed description
The goal of this non-pharmacological randomized interventional study is to investigate work-related stress in relation to the musculoskeletal health of employees.
The primary purpose of this study is to investigate if stress management interventions in employees can improve self-reported musculoskeletal health problems or Medically Unexplained Symptoms (MUS), in relation with biomarkers of stress.
Secondary outcomes will include quality of life improvement and the number of absences from work, due to musculoskeletal conditions.
The main question aims to answer if specific stress management techniques can improve the self-reported musculoskeletal health of employees.
Researchers will compare the results between two groups (one participating in the the six (6) week program and the other not participating) to measure the effect size in the intervention group and between groups.
Participants from both groups will be measured twice (on week 1 and week 8) with the same self-report questionnaires and stress biomarkers, if possible. Especially for the intervention group a six-week stress management program will be applied. This will include the participation in one and a half hour consultation meetings about stress, musculoskeletal health, psychosocial work-related factors, and how to improve well-being and work/life satisfaction.
- Conditions
- Musculoskeletal Diseases or Conditions, Musculoskeletal Pain, Musculoskeletal Health, Stress, Work Related Stress, Occupation-related Stress Disorder
- Being tested
- Diaphragmatic breathing (DF), Progressive Muscle Relaxation (PMR)
- Keywords
- stress management, stress biomarkers, musculoskeletal health, work-related, biofeedback, saliva cortisol, HRV
- Medical subject headings
- Musculoskeletal Diseases, Musculoskeletal Pain, Occupational Stress, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathing (DF)Other
Diaphragmatic breathing (DF), also known as belly or abdominal breathing, is a technique that can teach people how to use their diaphragm correctly while breathing, in order to activate the parasympathetic branch of the autonomic nervous system and to control stress.
Progressive Muscle Relaxation (PMR)Other
Progressive Muscle Relaxation (PMR) is a technique that is helpful in the reduction of stress.
PMR by alternately tensing and relaxing different muscle groups in the body helps participants to become more aware of physical sensations and can be particularly helpful to muscle tension and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Stress Managemenet Group | Experimental | Participants will be instructed and trained with two stress management techniques (Diaphragmatic Breathing- DB and Progressive Muscle Relaxation-PMR), along with biofeedback training in diaphragmatic breathing.
During the eight weeks of the program, participants in the intervention group will receive information regarding stress, work-related stress factors, musculoskeletal health and disorders, the Medically Unexplained Symptoms-MUS, occupational psychosocial hazards, lifestyle habits (healthy diet, sedentary life, sleep, hygiene).
Moreover, participants will be informed about how to manage stress related factors at the workplace, and its symptoms, through lifestyle modifications along with ergonomic guidance at work and in relation with their musculoskeletal health, the psychosocial hazards at work and their body response to work-related stress. Receives: Other: Diaphragmatic breathing (DF); Other: Progressive Muscle Relaxation (PMR) |
| Control Group-CG | No intervention | Participants will receive only information regarding ergonomic practices and tips able to be appilied at the workplace. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV)
Heart Rate Variability (HRV) has been widely used as an indicator for work-related stress. It measures the variation in time between each heartbeat and is controlled by the autonomic nervous system.
Measured: 8 weeks
Saliva cortisol
Salivary cortisol has been used as an indicator for stress. Pre-post intervention differences between diurnal circadian rhythm in the saliva cortisol of the participants will be measured, in order to evaluate the efficiency of the intervention upon homeostatic load.
Measured: 8 weeks
Musculoskeletal symptoms
Musculoskeletal symptoms will be assessed with the Nordic Musculoskeletal Questionnaire (NMQ). NMQ is a standardized questionnaire for the assessment of musculoskeletal problems in nine different body regions (neck, shoulders, upper back, elbows, wrist/hands, lower back, hips/thighs, knees, ankles/feet). General questions include 40 forced-choice items where responders could indicate if they had musculoskeletal problems (aches, pain, discomfort) in the last 12 months or seven days. Additional questions ask the participants to report if the musculoskeletal problems had led to inability to perform daily tasks and normal activities.
Work-related stress can lead to physical strain, which in turn can lead to musculoskeletal tension and disorders. Musculoskeletal disorders (MSDs) are a common type of occupational diseases and have become the main cause of absenteeism and early retirement in the working population.
Measured: 8 weeks
Secondary outcomes (1)
Sort Form Health Survey questionnaire (SF-36)
Quality of life will be measured with the Short Form survey (SF-36) self-report questionnaire. SF-36 provides comprehensive information of an individual health status and assesses eight domains of health such as: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/ fatigue (vitality), Emotional wellbeing, Social functioning, Pain, and General health. It provides valuable insights into participants' perceived health status and overall quality of life. All questions are scored on a scale from 0 to 100, reflecting a range from lowest to highest possible quality of life.
Scoring the SF-36 involves a two-step process. At first each question must be pre- coded with a numeric value which is then recorded according to a scoring key and then the second step involves averaging the recorded values from items within the same scale to compute the total scale score.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Diseases or ConditionsStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Model description
- interventional group and control group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- University of Athens
- Responsible party
- Principal investigator, Eleni Zigkiri, University of Thessaly
- Investigators
- Eleni Zigkiri, PhD (c), Principal investigator, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488547
- Sponsor's protocol ID
- 2224/14-04-2022
- Acronym
- MUStress
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nakao M. Work-related stress and psychosomatic medicine. Biopsychosoc Med. 2010 May 26;4(1):4. doi: 10.1186/1751-0759-4-4.
PubMed 20504368Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.
PubMed 28478782Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.
PubMed 25101026Eatough EM, Way JD, Chang CH. Understanding the link between psychosocial work stressors and work-related musculoskeletal complaints. Appl Ergon. 2012 May;43(3):554-63. doi: 10.1016/j.apergo.2011.08.009. Epub 2011 Sep 23.
PubMed 21944295Buscemi V, Chang WJ, Liston MB, McAuley JH, Schabrun SM. The Role of Perceived Stress and Life Stressors in the Development of Chronic Musculoskeletal Pain Disorders: A Systematic Review. J Pain. 2019 Oct;20(10):1127-1139. doi: 10.1016/j.jpain.2019.02.008. Epub 2019 Feb 22.
PubMed 30797962Maina G, Palmas A, Bovenzi M, Filon FL. Salivary cortisol and psychosocial hazards at work. Am J Ind Med. 2009 Mar;52(3):251-60. doi: 10.1002/ajim.20659.
PubMed 19023870Wang J, Zhu L, Song L, Zhou Z, Chan W, Li G, Zhou L, Xiao J, Lian Y. A cohort study on the association between changing occupational stress, hair cortisol concentration, and hypertension. PLoS One. 2023 May 17;18(5):e0285623. doi: 10.1371/journal.pone.0285623. eCollection 2023.
PubMed 37196014
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Disorders and Stress Management, in Employees
- ClinicalTrials.gov ID
- NCT06488547
- Acronym / sponsor ID
- MUStress / 2224/14-04-2022
- Conditions
- Musculoskeletal Diseases or Conditions, Musculoskeletal Pain, Musculoskeletal Health, Stress, Work Related Stress, Occupation-related Stress Disorder
- Keywords
- stress management, stress biomarkers, musculoskeletal health, work-related, biofeedback, saliva cortisol, HRV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- University of Athens
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jul 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.
This study aims to evaluate potential correlation of stress as estimated by certain biological markers, namely saliva cortisol, Heart rate variability (HRV), Electromyography (EMG) with musculoskeletal system health status, and assess the impact of a stress management intervention..The intervention group will be trained to apply two evidence based stress management techniques and they will be guided with tips and advice about musculoskeletal health.
Impact of the intervention upon measured stress related markers will be assessed.
Detailed description
The goal of this non-pharmacological randomized interventional study is to investigate work-related stress in relation to the musculoskeletal health of employees.
The primary purpose of this study is to investigate if stress management interventions in employees can improve self-reported musculoskeletal health problems or Medically Unexplained Symptoms (MUS), in relation with biomarkers of stress.
Secondary outcomes will include quality of life improvement and the number of absences from work, due to musculoskeletal conditions.
The main question aims to answer if specific stress management techniques can improve the self-reported musculoskeletal health of employees.
Researchers will compare the results between two groups (one participating in the the six (6) week program and the other not participating) to measure the effect size in the intervention group and between groups.
Participants from both groups will be measured twice (on week 1 and week 8) with the same self-report questionnaires and stress biomarkers, if possible. Especially for the intervention group a six-week stress management program will be applied. This will include the participation in one and a half hour consultation meetings about stress, musculoskeletal health, psychosocial work-related factors, and how to improve well-being and work/life satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- interventional group and control group
| Arm | Type | Receives |
|---|---|---|
| Stress Managemenet Group | Experimental | Other: Diaphragmatic breathing (DF), Other: Progressive Muscle Relaxation (PMR)Participants will be instructed and trained with two stress management techniques (Diaphragmatic Breathing- DB and Progressive Muscle Relaxation-PMR), along with biofeedback training in diaphragmatic breathing. During the eight weeks of the program, participants in the intervention group will receive information regarding stress, work-related stress factors, musculoskeletal health and disorders, the Medically Unexplained Symptoms-MUS, occupational psychosocial hazards, lifestyle habits (healthy diet, sedentary life, sleep, hygiene). Moreover, participants will be informed about how to manage stress related factors at the workplace, and its symptoms, through lifestyle modifications along with ergonomic guidance at work and in relation with their musculoskeletal health, the psychosocial hazards at work and their body response to work-related stress. |
| Control Group-CG | No intervention | –Participants will receive only information regarding ergonomic practices and tips able to be appilied at the workplace. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Writing and reading greek.
- Consent to provide their medical history.
- Consent to be measured with electronic devices.
Key exclusion criteria (8 listed)
- Employees who are close to retirement (at least 2 years before) and those for whom any known factor may prevent them from completing the intervention (eg travel, transfer).
- Pregnancy.
- Pacemaker, history of seizures.
- Diagnosed musculoskeletal injury.
- Diagnosed diseases such as: osteoarthritis, autoimmune diseases (rheumatoid arthritis, lupus, etc.), stroke, myocardial infarction, malignant neoplasms, psychiatric disease, disability.
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 |
|---|---|---|
| Diaphragmatic breathing (DF)Diaphragmatic breathing (DF), also known as belly or abdominal breathing, is a technique that can teach people how to use their diaphragm correctly while breathing, in order to activate the parasympathetic branch of the autonomic nervous system and to control stress. | Other | Stress Managemenet Group |
| Progressive Muscle Relaxation (PMR)Progressive Muscle Relaxation (PMR) is a technique that is helpful in the reduction of stress. PMR by alternately tensing and relaxing different muscle groups in the body helps participants to become more aware of physical sensations and can be particularly helpful to muscle tension and relaxation. | Other | Stress Managemenet Group |
Primary outcome
Heart Rate Variability (HRV)
Time frame: 8 weeks
Heart Rate Variability (HRV) has been widely used as an indicator for work-related stress. It measures the variation in time between each heartbeat and is controlled by the autonomic nervous system.
Saliva cortisol
Time frame: 8 weeks
Salivary cortisol has been used as an indicator for stress. Pre-post intervention differences between diurnal circadian rhythm in the saliva cortisol of the participants will be measured, in order to evaluate the efficiency of the intervention upon homeostatic load.
Musculoskeletal symptoms
Time frame: 8 weeks
Musculoskeletal symptoms will be assessed with the Nordic Musculoskeletal Questionnaire (NMQ). NMQ is a standardized questionnaire for the assessment of musculoskeletal problems in nine different body regions (neck, shoulders, upper back, elbows, wrist/hands, lower back, hips/thighs, knees, ankles/feet). General questions include 40 forced-choice items where responders could indicate if they had musculoskeletal problems (aches, pain, discomfort) in the last 12 months or seven days. Additional questions ask the participants to report if the musculoskeletal problems had led to inability to perform daily tasks and normal activities. Work-related stress can lead to physical strain, which in turn can lead to musculoskeletal tension and disorders. Musculoskeletal disorders (MSDs) are a common type of occupational diseases and have become the main cause of absenteeism and early retirement in the working population.
1 secondary outcome
Sort Form Health Survey questionnaire (SF-36)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Results publication: PubMed 20504368Nakao M. Work-related stress and psychosomatic medicine. Biopsychosoc Med. 2010 May 26;4(1):4. doi: 10.1186/1751-0759-4-4.
- Results publication: PubMed 28478782Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.
- Results publication: PubMed 25101026Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.
- Results publication: PubMed 21944295Eatough EM, Way JD, Chang CH. Understanding the link between psychosocial work stressors and work-related musculoskeletal complaints. Appl Ergon. 2012 May;43(3):554-63. doi: 10.1016/j.apergo.2011.08.009. Epub 2011 Sep 23.
- Results publication: PubMed 30797962Buscemi V, Chang WJ, Liston MB, McAuley JH, Schabrun SM. The Role of Perceived Stress and Life Stressors in the Development of Chronic Musculoskeletal Pain Disorders: A Systematic Review. J Pain. 2019 Oct;20(10):1127-1139. doi: 10.1016/j.jpain.2019.02.008. Epub 2019 Feb 22.
- Results publication: PubMed 19023870Maina G, Palmas A, Bovenzi M, Filon FL. Salivary cortisol and psychosocial hazards at work. Am J Ind Med. 2009 Mar;52(3):251-60. doi: 10.1002/ajim.20659.
- Results publication: PubMed 37196014Wang J, Zhu L, Song L, Zhou Z, Chan W, Li G, Zhou L, Xiao J, Lian Y. A cohort study on the association between changing occupational stress, hair cortisol concentration, and hypertension. PLoS One. 2023 May 17;18(5):e0285623. doi: 10.1371/journal.pone.0285623. eCollection 2023.
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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.
Eleni Zigkiri, PhD (c) principal investigator
University of Thessaly
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing (DF) and Progressive Muscle Relaxation (PMR) in people with Musculoskeletal Diseases or Conditions and Musculoskeletal Pain, run by University of Thessaly at 2 sites 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleni Zigkiri, PhD (c) (+30 6878180765, ezigkiri@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) (time frame: 8 weeks). The study lists 3 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 NCT06488547, which also lists 7 linked publications.
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 5 Jul 2024.