- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07564492
Whole-Body Vibration vs. Exercises for Chronic Neck Pain in Young Adults
Comparison of the Effects of Whole-Body Vibration and Exercise Interventions on Sensorimotor Function in Young Individuals With Chronic Neck Pain
Chronic neck pain is a prevalent issue among young adults, potentially impacting pain levels, range of motion, posture, balance, and daily functional activities. This study is designed to compare two distinct physical therapy interventions for young individuals diagnosed with chronic non-specific neck pain: Whole-Body Vibration (WBV), involving standing on a vibrating platform, and Sensorimotor Exercise (SME), which focuses on improving neck awareness, coordination, balance, and motor control.
The primary objective is to determine whether one of these therapeutic approaches is more effective than the other in enhancing neck-related sensorimotor function, reducing pain intensity, and improving overall functional capacity over a 4-week intervention period. The study population consists of male and female university students aged 18 to 30 years presenting with chronic neck pain. The investigators anticipate that while both intervention protocols may yield clinical benefits, the comparative results will demonstrate which method provides superior short-term improvements in pain management and cervical function.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Denizli
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Denizli, Denizli, Turecko (Türkiye), 20160
- Pamukkale University, Faculty of Physiotherapy and Rehabilitation.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Diagnosis of non-specific neck pain,
- Age of 18 years or older,
- History of neck pain for at least 3 months,
- Pain intensity score of 3 or higher on the Visual Analog Scale (VAS),
- Functional disability score of 5 or higher on the Neck Disability Index (NDI),
- Sufficient literacy to complete the assessment scales.
Exclusion Criteria:
- Diagnosis of disc herniation or spinal stenosis,
- History of spinal surgery or major trauma,
- Systemic conditions such as rheumatoid arthritis or advanced arthrosis,
- Neurological diseases or balance disorders,
- Severe pain in other body parts or recent lower extremity injuries.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Vibrace celého těla
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Participants received Whole-Body Vibration (WBV) training 3 days a week for a total of 4 weeks, totaling 12 sessions.
Each session consisted of 10 sets of vibration.
Each set involved 30 seconds of vibration followed by a 30-second rest period.
The training was performed on a Compex Winplate™ vibration platform at a frequency of 30 Hz and an amplitude of 4 mm.
Participants performed the exercises barefoot while maintaining various positions, starting from a static semi-squat (15° mini-squat) and progressing to more dynamic and advanced balance tasks across three levels.
Each session initially lasted 12-15 minutes and progressed to 20-25 minutes based on participant tolerance.
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Aktivní komparátor: Sensorimotor Training
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Participants underwent a structured and progressive sensorimotor exercise program conducted 3 days a week for a total of 4 weeks.
The protocol was tailored across three stages, with session durations increasing from an initial 12-15 minutes to 20 minutes.
Key components included oculomotor and eye-head coordination tasks using a laser pointer for gaze stability, as well as static and dynamic balance exercises that progressed from wide to narrow bases of support and from stable to unstable surfaces.
Additionally, the program incorporated deep neck flexor strengthening through precision-focused chin-tuck exercises using small exercise balls, and functional tasks such as squatting combined with laser pointer tracking.
Exercises progressed from 5-7 repetitions to 10-12 repetitions per session based on individual tolerance, with 1-3 minute rest intervals provided between sets.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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hange from Baseline in Functional Disability Score on the Neck Disability Index (NDI).
Časové okno: Baseline and at the end of treatment (4 weeks).
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The disability level of the participants related to neck pain was measured using the Neck Disability Index (NDI), which is the most widely used region-specific assessment tool.
Developed by Vernon and Mior, this questionnaire is valid, reliable, and sensitive for both acute and chronic conditions, including musculoskeletal neck pain, whiplash injury, and cervical radiculopathy.
The Turkish cultural adaptation, validity, and reliability were established by Aslan Telci et al.
The NDI consists of 10 sections, each scored from 0 to 5 (0 = no disability, 5 = most severe disability), covering pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep, and leisure activities.
Total scores range from 0 to 50, where higher scores indicate greater disability.
Disability levels are categorized as: 0-4 points (no disability), 5-14 points (mild), 15-24 points (moderate), 25-34 points (severe), and 35 or above (total).
The minimal clinically important difference.
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Baseline and at the end of treatment (4 weeks).
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Visual Analog Scale (VAS)
Časové okno: Baseline and at the end of treatment (4 weeks).
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Participants' pain perception was evaluated using the VAS, a tool widely utilized in clinical and scientific research that ranges from 0 to 10 points (0=no pain, 10=maximum pain).
Pain intensity was categorized according to the classification described, using the VAS scoring system, which is a validated and reliable scale for measuring musculoskeletal pain.
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Baseline and at the end of treatment (4 weeks).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Joint Position Sense Error (JPSE) test.
Časové okno: Baseline and at the end of treatment (4 weeks).
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For the evaluation of cervical Joint Position Sense (JPS), the CROM device was preferred as it is an effective, simple, and cost-efficient measurement tool, similar to its use in Range of Motion (ROM) assessment.
This ensured consistency across the evaluation environment, preparation phase, standardized measurement posture, device placement, and calibration.
The participants' cervical ROM in three planes was measured three times, and the arithmetic mean of these measurements served as the baseline for JPS assessment.
The target angle for the JPS test was then calculated as 65% of the average ROM for the respective cervical movement.
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Baseline and at the end of treatment (4 weeks).
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Cervical Range of Motion (CROM) device.
Časové okno: Baseline and at the end of treatment (4 weeks).
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Active cervical flexion, extension, right-left rotation, and right-left lateral flexion were evaluated using the Baseline CROM Deluxe device.
The CROM device consists of two gravity-dependent goniometers and a head-mounted compass dial, allowing for range of motion (ROM) measurements across three anatomical planes.
During the assessments, participants were instructed to sit with their feet flat on the floor, hands resting on their thighs, and the pelvis in a neutral position.
For active movements, they were asked to move the head at a constant speed while keeping the back and shoulders stationary, followed by a 5-10 second rest in the neutral position after each movement.
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Baseline and at the end of treatment (4 weeks).
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Cervical Deep Neck Flexor Muscle Endurance Test.
Časové okno: Baseline and at the end of treatment (4 weeks).
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To assess the functional stability of the cervical region, the endurance of the deep flexor muscles, which play a critical role in stabilization, was evaluated using the Cervical Deep Neck Flexor Endurance Test.
Participants were positioned supine in a hook-lying position with their hands resting on their abdomen.
Before the assessment, the craniocervical flexion (chin tuck) movement was explained verbally and demonstrated by the researcher; a 5-minute rest period was provided following a brief practice trial to prevent muscle fatigue.
During the test, participants were instructed to perform craniocervical flexion, lift their heads approximately 2,5 cm off the surface, and maintain this position for as long as possible.
The duration for which the position was maintained was recorded in seconds.
The test was terminated if craniocervical flexion was lost, the head touched the surface, pain increased suddenly or severely, or if the participant requested to stop.
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Baseline and at the end of treatment (4 weeks).
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Gaze Stability Test
Časové okno: Baseline and at the end of treatment (4 weeks)
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To assess gaze stability, the Head-Eye Movement Control Test was conducted. For participant safety, the testing area was positioned in a corner of the room. A camera was mounted on a tripod at eye level at the center of a 1-meter equilateral triangle marked on the floor. Participants were seated in a neutral position and instructed to rotate their head as rapidly as possible to the right and left while maintaining visual fixation on the camera lens. Performance was scored using a 3-point scale:
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Baseline and at the end of treatment (4 weeks)
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The Single-leg Stance Test
Časové okno: Baseline and at the end of treatment (4 weeks).
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Static balance was assessed using the Single-Leg Stance (SLS) test, performed separately for the right and left lower extremities under both eyes-open and eyes-closed conditions.
Three trials were conducted for each condition, and the mean duration was recorded.
The test was terminated if the weight-bearing foot shifted from its original position, the non-weight-bearing foot touched the floor, the participant sought external support, or the maximum duration of 60 seconds was reached.
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Baseline and at the end of treatment (4 weeks).
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Y-Balance Test (YBT).
Časové okno: Baseline and at the end of treatment (4 weeks).
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Dynamic postural was assessed using the Y-Balance Test (YBT).
Reach distances were measured in three directions: anterior (ANT), posterolateral (PL), and posteromedial (PM).
To allow for data normalization, participants' leg length was measured from the anterior superior iliac spine (ASIS) to the medial malleolus.
Following six practice trials to minimize learning effects, the maximum reach of three successful trials in each direction was recorded and normalized to leg length to calculate a composite balance score.
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Baseline and at the end of treatment (4 weeks).
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head posture analysis.
Časové okno: Baseline and at the end of treatment (4 weeks).
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To evaluate the alignment of the cervical spine, participants' head posture was assessed by measuring the craniovertebral angle (CVA).
The CVA is defined as the angle formed between the horizontal plane and a line connecting the midpoint of the tragus of the ear to the C7 spinous process.
Measurements were conducted using the photogrammetry technique while participants were in a standing position.
For this purpose, a digital camera was positioned at a fixed point 1.5 meters from the participant at shoulder level.
After placing an anatomical marker on the C7 spinous process, participants were instructed to bring their heads into a neutral position through small flexion and extension movements and to look at a fixed point directly in front of them.
CVA values were calculated from photographs taken from the left lateral projection.
A decrease in the CVA value was recorded as an indicator of increased anterior head posture (forward head displacement).
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Baseline and at the end of treatment (4 weeks).
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Fremantle Neck Awareness Questionnaire (FreNAQ).
Časové okno: Baseline and at the end of treatment (4 weeks).
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Neck-specific body perception and awareness were evaluated using the Fremantle Neck Awareness Questionnaire (FreNAQ).
This 9-item scale assesses body image, proprioception, and perceptual distortions of the neck region.
Each item is scored on a 5-point Likert scale (0 = never, 4 = always), with higher total scores indicating greater body image distortion.
The Turkish version of the FreNAQ has been previously validated and demonstrated high reliability for individuals with neck pain.
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Baseline and at the end of treatment (4 weeks).
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Bournemouth Neck Pain Questionnaire(BNPQ).
Časové okno: Baseline and at the end of treatment (4 weeks)
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For a detailed evaluation of neck pain and its multidimensional impacts, the seven-item Bournemouth Neck Pain Questionnaire (BNPQ) was utilized to assess participants' pain intensity, as well as kinesiophobia, anxiety, depression, and coping abilities.
This scale provides a biopsychosocial assessment by covering four of the five components of the International Classification of Functioning, Disability and Health (ICF), as it assesses pain intensity over the past week, disability in daily and social activities, levels of anxiety and depression, kinesiophobia, and pain control abilities.
The BNPQ was selected for its ability to determine the comprehensive effects of neck pain, and its Turkish version has demonstrated validity and reliability (Cronbach's alpha = 0.865; ICC = 0.963).
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Baseline and at the end of treatment (4 weeks)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Další identifikační čísla studie
- E-60116787-020-664846
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