- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07605013
Mobilization Techniques for Nonspecific Neck Pain: Effects on Cervical Endurance and Function
Comparison of Different Mobilization Techniques on Cervical Muscle Endurance and Functional Performance in Patients With Nonspecific Neck Pain
This clinical study investigates the comparative effects of two manual therapy mobilization techniques, Positional Release Technique (PRT) and Instrument-Assisted Soft Tissue Mobilization (İASTM), on cervical muscle endurance and functional performance in individuals with nonspecific neck pain. Nonspecific neck pain is a common musculoskeletal condition among office workers and students, often associated with poor posture, prolonged sitting, and repetitive strain. It leads to reduced muscle endurance, impaired functional capacity, and decreased quality of life. Early and effective management strategies are essential to prevent chronicity and disability.
A total of 51 participants will be recruited and randomly assigned into three groups: Group 1 will receive PRT combined with a standardized home exercise program, Group 2 will receive İASTM combined with the same home exercise program, and Group 3 will serve as the control group receiving only conventional home exercise. The interventions will be delivered over a period of 4 weeks, with three sessions per week, under the supervision of trained physiotherapists. The home exercise program includes stretching, strengthening, and posture correction exercises designed to support cervical spine health.
The primary outcomes of the study are cervical muscle endurance and functional performance, measured using validated clinical tests. Secondary outcomes include pain intensity assessed by the Visual Analog Scale (VAS), functional disability measured by the Neck Disability Index (NDI), health-related quality of life assessed by the SF-12 questionnaire, and work-related performance indicators. Assessments will be conducted at baseline and after 4 weeks of intervention. Randomization and blinding procedures will be applied to minimize bias, and standardized protocols will ensure consistency across groups.
The main objective of this study is to determine whether the early application of PRT or İASTM, in combination with home exercise, provides superior improvements in cervical muscle endurance, pain reduction, and functional outcomes compared to exercise alone. By comparing these two mobilization techniques, the study aims to contribute evidence-based knowledge to physiotherapy practice and guide clinicians in selecting effective manual therapy approaches for nonspecific neck pain. The findings are expected to support clinical decision-making, improve patient care, and enhance rehabilitation strategies for individuals suffering from neck pain in occupational and daily life contexts.
Přehled studie
Postavení
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: GUNEY SHIRVANOVA, BSc PT
- Telefonní číslo: +994515765931
- E-mail: guneyshirvanova@ogr.iuc.edu.tr
Studijní záloha kontaktů
- Jméno: YILDIZ ANALAY AKBABA, Prof.Dr
- Telefonní číslo: +902124115284 +905323774013
- E-mail: yildizanalay@iuc.edu.tr
Studijní místa
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Istanbul, Turecko (Türkiye), 34098
- Nábor
- Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Healthy Living Laboratory
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Kontakt:
- GUNEY SHIRVANOVA, BSc PT
- Telefonní číslo: +994515765931
- E-mail: guneyshirvanova@ogr.iuc.edu.tr
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Kontakt:
- YILDIZ ANALAY AKBABA, Prof.Dr
- Telefonní číslo: +902124115284 +905323774013
- E-mail: yildizanalay@iuc.edu.tr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Healthy individuals aged 18-40 years
- Individuals working at a desk job (office or remote) for at least 6 hours per day
- Physically active individuals with no neck pain (NPRS score 0-2)
- Voluntary consent to participate in the study
Exclusion Criteria:
- History of neck trauma, surgery, or any cardiovascular, metabolic, neurological, or rheumatoid arthritis condition within the last 6 months
- Participation in a manual therapy or physiotherapy program within the last 6 months
- Presence of severe malignancy, rheumatoid arthritis, or cardiovascular disease
- Pregnancy or breastfeeding
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: Positional Release Technique Group (PRT Group)
Participants receive Positional Release Technique sessions three times per week for four weeks (12 sessions total, 45-60 minutes each).
The intervention focuses on upper trapezius and sternocleidomastoid trigger points, combined with home exercises including stretching, chin tuck endurance, and scapular stabilization.
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The Positional Release Technique involves passive positioning of the cervical spine to relieve muscle tension at trigger points.
Each position is held for 90 seconds and repeated three times per session.
Participants receive 12 sessions over 4 weeks (3 sessions per week, 45-60 minutes each).
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Experimentální: Instrument-Assisted Soft Tissue Mobilization Group (İASTM Group)
Participants receive Instrument-Assisted Soft Tissue Mobilization three times per week for four weeks (12 sessions total, 45-60 minutes each).
Stainless steel tools are used at 30-60° angles along muscle fibers.
Home exercises include stretching, chin tuck endurance, and scapular stabilization.
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Instrument-Assisted Soft Tissue Mobilization uses stainless steel tools applied at 30-60° angles along muscle fibers to reduce soft tissue restrictions.
Each area is treated for 60-90 seconds, with total manual contact lasting 8-12 minutes per session.
Participants receive 12 sessions over 4 weeks (3 sessions per week, 45-60 minutes each).
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Aktivní komparátor: Control Group (Exercise Only)
Participants perform only home exercise programs three times per week for four weeks (45-60 minutes each).
Exercises include stretching, chin tuck endurance, and scapular stabilization.
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Participants perform only home exercise programs three times per week for four weeks (45-60 minutes each session).
Exercises include static stretching of the upper trapezius, levator scapula, and scalene muscles (30 seconds × 3 sets), chin tuck endurance exercise (10 seconds × 10 repetitions), and scapular stabilization strengthening (3 sets × 10-15 repetitions).
Exercises are guided by video instructions and mobile reminders.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Neck Disability Index (NDI)
Časové okno: Baseline and 4 weeks after intervention.
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The Neck Disability Index (NDI) is a validated, patient-reported questionnaire consisting of 10 items that assess neck-related disability in daily life.
The domains include pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreational activities.
Each item is scored on a 0-5 scale, resulting in a total score ranging from 0 to 50.
A score of 0 indicates no disability, while a score of 50 indicates maximum disability.
Scores are typically converted into percentages (0-100%), with lower scores reflecting better functional status and higher scores reflecting greater disability.
The NDI is widely used in clinical trials as a primary outcome measure for neck pain and has demonstrated strong reliability, validity, and responsiveness to change.
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Baseline and 4 weeks after intervention.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: GUNEY SHIRVANOVA, BSc PT, Istanbul University-Cerrahpasa, Department of Physical Therapy and Rehabilitation
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
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026/19 (Ethics Committee Approval from RTEU Non-Interventional Clinical Research Ethics Committee)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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