NCT06666478

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
980

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

October 19, 2024

Last Update Submit

October 29, 2024

Conditions

Keywords

exercise at workspace

Outcome Measures

Primary Outcomes (7)

  • 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.

    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").

    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).

    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.

    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.

    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.

    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.

    From enrollment to the end of the treatment at 6 weeks and 2 weeks after the end of the treatment

Study Arms (2)

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.

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.

Interventions

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.

Exercise protocol at workspace

Eligibility Criteria

Age19 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Employment as nurses, doctors, or surgeons
  • Manual labor in distribution warehouses
  • Manual labor in heavy industry

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education, Sport Science and Occupational Therapy

Komotini, 69132, Greece

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anastasia Gr Beneka, Professor

    Democritus University of Thrace

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Physical Rehabilitation

Study Record Dates

First Submitted

October 19, 2024

First Posted

October 30, 2024

Study Start

January 8, 2024

Primary Completion

October 15, 2024

Study Completion

October 15, 2024

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Individual Participant Data will not be shared with anybody because of the Companies/Organizations GDPR policy. They are very sensitive with the GDPR.

Locations