- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07562737
Neck Pain in Office Workers
Effect Of Short Neck-Stretching Exercise Breaks On Neck Pain And Related Factors In Office Workers
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study investigates the effectiveness of brief exercise breaks of different durations (2, 5, and 7 minutes) in managing chronic non-specific neck pain among office workers. Neck pain is highly prevalent in individuals exposed to prolonged computer use and static postures, and it is associated with reduced quality of life, decreased work productivity, and increased occupational strain. Although exercise-based interventions are recommended, adherence to traditional home programs remains low, highlighting the need for simple and time-efficient strategies.
The study was designed as a 12-week, double-blind, randomized controlled trial. Participants with chronic non-specific neck pain and are randomly assigned to one of three intervention groups (2-, 5-, or 7-minute exercise programs) or a control group. We plan to enroll at least 120 participants.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Lt-44221
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Kaunas, Lt-44221, Litva, 44221
- Department of health promotion and rehabilitation
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Office workers engaged in sedentary work for at least 6 hours per day.
Exclusion Criteria:
- individuals with a specific neck diagnosis or acute neck pain.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 2 min exercise
Participants of this arm have uing work hours to complete 2 min exercise programme each hour
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Participants are required to perform the exercises during working hours, once every hour throughout the workday.
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Aktivní komparátor: 5 min exercise
Participants of this arm have uing work hours to complete 5 min exercise programme each hour
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Participants in this group are required to perform the 5 min duration exercises during working hours, once every hour throughout the workday.
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Aktivní komparátor: 7 min exercise
Participants in this group are required to perform the 7 min duration exercises during working hours, once every hour throughout the workday.
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Participants in this group are required to perform the 7 minn duration exercises during working hours, once every hour throughout the workday.
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Žádný zásah: Controls
participants of this group will not get any intervention
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Neck Disability Index
Časové okno: Pre-post intervention (12 week)
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The questionnaire consists of 10 items, each scored from 0 to 5. The total score is interpreted as a percentage, where 0 points or 0% indicates no ac-tivity limitation, and 50 points or 100% indicates complete activity limitation.
The NDI is a reliable and valid tool for assessing patients with neck pain, with intraclass correlation coefficients ranging from 0.50 to 0.98.
Patients scoring between 0-4 points (0-8%) are considered to have no disability, 5-14 points (10-28%) mild disability, 15-24 points (30-48%) moderate disability, 25-34 points (50-64%) severe disability, and 35-50 points (70-100%) complete disability
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Pre-post intervention (12 week)
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Postural stability
Časové okno: Pre-post intervention (12 week)
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Postural stability is assessed using the Biodex Balance System (BBS; Biodex Medical Systems Inc., Shirley, NY, USA), a validated computerized platform widely used to quantify balance performance and neuromuscular control in both healthy and clinical populations.
Participants stood barefoot on the dynamic platform, with foot placement standardized by the system to ensure consistency across trials.
They were instructed to maintain an upright posture with hands on the hips and to focus on a monitor positioned in front of them, which provided real-time visual feedback, enabling continuous monitoring and voluntary correction of postural sway (Biodex Medical Systems, 2020).Outcome measures automatically recorded by the BBS included the Overall Stability Index), Anterior-Posterior Stability Index, Medial-Lateral Stability Index, Overall Sway Index, Anterior-Posterior Sway Index, Medial-Lateral Sway Index, and Time-in-Zones percentages.
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Pre-post intervention (12 week)
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Bilateral Coordination
Časové okno: Pre-post (12 wek)
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Bilateral coordination are assessed using the Bilateral Comparison Test module of the Biodex Balance System (BBS), which evaluates static postural sway and interlimb symmetry under controlled conditions [24, 25]. Participants performed a single trial consisting of a 10-second single-leg stance on the left leg followed immediately by a 10-second single-leg stance on the right leg. All trials were conducted barefoot, with hands placed on the hips, while the platform remained static to isolate static balance control. The BBS automatically generate the following outcome measures: Overall Left and Right Sway Indices, Overall Interlimb Difference, Anterior-Posterior (A/P) Left and Right Sway Indices, A/P Interlimb Difference, and Medial-Lateral (M/L) Left and Right Sway Indices, as well as M/L Interlimb Difference (Supplementary Figure 2). Lower sway index values indicate better postural stability, reflecting reduced body sway. Smaller interlimb differences indicate greater bilateral symme |
Pre-post (12 wek)
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Manual dexterity performance (Purdue Pegboard Test)
Časové okno: Pre-post (12 week)
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The Purdue Pegboard Test Model #32020A was used to assess unimanual and bimanual finger and hand dexterity performance among office workers with neck pain.
This test was recognized as a reliable and valid tool for fine motor skills assessment and can be used for assessment in case of a variety of neurological disorders.
The three test batteries were performed: 1) dominant hand; 2) non dominant hand; 3) both hands.
The test procedures were performed according to the Purdue Pegboard Test User Instructions.
The board was placed on a table in front of the subject comfortably sitting on a chair.
The top right and left cups were filled with 25 pins in each to equal a total of 50 pins.
Before performing the test the subject was instructed: "This is a test to see how quickly and accurately you can work with your hands.
Before you begin each battery of the test, you will be told what to do and then you will have an opportunity to practice.
Be sure you understand exactly what to do.
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Pre-post (12 week)
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Miotonometry
Časové okno: Pre-post (12 week)
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Muscle tone was assessed using a myotonometer.
The tone of the upper trapezius muscle was measured with a Myoton PRO device (Myoton AS, Tallinn, Estonia).
This method allows for a simple and noninvasive evaluation of the mechanical properties of muscles and demonstrates high reliability, with an intra-rater correlation coefficient ranging from 0.94 to 0.99.
Participants were seated on a chair with back support with both hands resting on their thighs and looked straight ahead during the measurements.
Measurements were performed on the upper trapezius muscle bilaterally (right and left) at the midpoint of the line connecting the spinous process of the C7 vertebra and the acromion of the scapula.
Three biomechanical parameters were recorded: muscle tone (Hz), elasticity (logarithmic decrement), and stiffness (N/m).
During the measurement, the skin was preloaded with a force of 0.18 N, followed by five mechanical impulses of 0.4 N applied at 15-second interval
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Pre-post (12 week)
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Neck pain
Časové okno: pre and post intervention (12 week)
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Numeric pain scale. Participants rate their pain on a scale from 0 to 10, where: 0 = no pain,10 = worst imaginable pain |
pre and post intervention (12 week)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Age
Časové okno: Once- pre intervention
|
in years
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Once- pre intervention
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Body Composition
Časové okno: Pre-post (12 week)
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Body height was measured using a wall-mounted stadiometer equipped with a centimeter scale.
Body composition was assessed using a bioelectrical impedance analyzer (TANITA BC 240 SMA, Tanita, Tokyo, Japan).
The body composition parameters evaluated in this study included fat mass (kg and %), fat-free mass (kg and %), and muscle mass (kg and %).
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Pre-post (12 week)
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Sleep Quality (Numeric Scale)
Časové okno: pre-post (12 week)
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Sleep quality was assessed using a numeric rating scale. Participants rated their overall sleep quality on a scale from 0 to 10, where 0 indicated very poor sleep and 10 indicated excellent sleep. Higher scores reflect better perceived sleep quality. The SQS is a self-administered questionnaire that incorporates a discretizing VAS. The questionnaire instructions direct the respondent to rate the overall quality of sleep over a 7-day recall period on a discretizing VAS, whereby the respondent marks an integer score from 0 to 10, according to the following five categories: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent |
pre-post (12 week)
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Minnesota Satisfaction Questionnaire
Časové okno: Pre-post (12 week)
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The MSQ-Short Form consists of 20 items assessing intrinsic (12 items) and extrinsic (8 items) job satisfaction.
Items are rated on a 5-point Likert scale from 1 (very dissatisfied) to 5 (very satisfied).
The global satisfaction score is calculated by averaging all item scores.
The neutral score is 3; scores above 3 indicate high job satisfaction, while scores below 3 indicate low job satisfaction.
The maximum total score is 100, representing the highest possible job satisfaction.
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Pre-post (12 week)
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Hand Grip Strength
Časové okno: Pre-post (12 week)
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Grip strength was measured using a Saehan SH5001 hand dynamometer (Germany).
Measurements for both the dominant and non-dominant hands were taken.
The maximum grip strength was recorded in kilograms (kg).
Three measurements were taken with 15 seconds of rest between each trial, and the average result was recorded
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Pre-post (12 week)
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Short Form-36 Health Surve
Časové okno: Pr-post (12 week)
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is a widely used patient-reported questionnaire designed to assess health-related quality of life (HRQoL) in both clinical and general populations.
It consists of 36 items covering eight health domains: Physical functioning Role limitations due to physical health Bodily pain General health perceptions Vitality (energy/fatigue) Social functioning Role limitations due to emotional problems Mental health Each domain is scored on a scale from 0 to 100, where higher scores indicate better health status and functioning.
The SF-36 provides two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
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Pr-post (12 week)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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