- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07813871
Effect of Cervical Force Control Training on Force Sense and Steadiness in Chronic Non-Specific Neck Pain
Chronic non-specific neck pain (CNSNP) is a very common issue among young adults, often linked to poor posture, prolonged screen time, and sedentary habits. This persistent pain can change how the neck muscles work and control movement. The purpose of this study is to investigate whether a specific type of rehabilitation-called "cervical force control training"-can help improve how well people can feel and control their neck muscle strength, and whether this reduces their pain and improves their daily function.
Researchers will invite young adults (18 to 24 years old) who have had neck pain for at least 3 months to participate. Participants will be randomly divided into two groups:
Force Control Training Group: Will receive a new training program that uses a handheld dynamometer with a screen to help them practice holding steady, precise neck muscle contractions with visual feedback.
Conventional Exercise Group: Will receive a standard physical therapy program consisting of neck muscle stretches and shoulder-blade strengthening exercises.
Both groups will perform their exercises 3 times a week for 8 weeks. Researchers will measure participants' neck muscle steadiness, pain levels, and neck disability before the program starts, right after the 8-week program ends, and again at a 3-month follow-up to evaluate the long-lasting effects.
Přehled studie
Postavení
Detailní popis
Chronic non-specific neck pain (CNSNP) involves persistent cervical pain without an identifiable structural pathology. Recent evidence suggests that CNSNP is closely associated with sensorimotor control deficits, including impaired proprioception and diminished force steadiness (the neuromuscular ability to produce and sustain precise submaximal force levels with minimal fluctuations). While conventional exercises improve strength and reduce pain, they often neglect the fine-motor precision and sensorimotor integration necessary for optimal neck function.
This randomized controlled trial (RCT) is designed to investigate the effect of cervical force control training compared to conventional neck exercises on force sense, force steadiness, pain intensity, and functional disability in young adults (18-24 years) with CNSNP.
Following baseline assessments for maximum voluntary isometric contraction (MVIC), force sense, and force steadiness (quantified by the coefficient of variation) using a Handheld Dynamometer (HHD), as well as clinical measures (VAS for pain, NDI for disability), eligible participants will be randomized into two groups:
Experimental Group (Force Control Training):
Participants will undergo an 8-week targeted training program (3 sessions/week, 30-40 mins each). The protocol utilizes submaximal isometric contractions with visual feedback via an HHD device paired with an application. The program progresses systematically through three phases: Phase 1 (Calibration & Reference at MVIC), Phase 2 (Acquisition using descending submaximal intensities 25% to 10% MVIC with continuous visual tracking), and Phase 3 (Retention & Transfer involving faded/no feedback and complex dual-tasking, such as auditory monitoring or arithmetic).
Control Group (Conventional Exercise Training):
Participants will undergo an 8-week program (3 sessions/week, 30 mins each) consisting of standard cervical stretching (upper trapezius and levator scapulae) and scapular strengthening/stabilization exercises (e.g., side-lying external rotation, side-lying forward flexion, prone extension, and push-up plus). Resistance will be tailored based on gender and body weight.
Re-evaluations will be conducted immediately post-intervention (at 8 weeks) and at a 3-month follow-up. The study aims to establish whether integrating specific force-control tasks offers superior benefits in restoring sensorimotor function and alleviating symptoms in patients with CNSNP compared to conventional rehabilitation alone.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Mohamed M Refaey, M.Sc.
- Telefonní číslo: 00201030290667
- E-mail: mohamed_salama@pt.kfs.edu.eg
Studijní záloha kontaktů
- Jméno: Refaey
- E-mail: mohamed_salama@pt.kfs.edu.eg
Studijní místa
-
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt
- Faculty of Physical Therapy
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Kontakt:
- Mohamed M Refaey, M.Sc.
- Telefonní číslo: 00201030290667
- E-mail: mohamed_salama@pt.kfs.edu.eg
-
Vrchní vyšetřovatel:
- Mohamed M Refaey, M.Sc.
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Patients diagnosed with Chronic Non-Specific Neck Pain (CNSNP) lasting >= 3 months.
- Body mass index (BMI) between 18.5 and 29.9 kg/m² (non-obese).
- Pain intensity >= 30 mm on the Visual Analogue Scale (VAS).
- Neck disability ranging from mild to moderate (10% to 48%) on the Neck Disability Index (NDI).
- Able to perform isometric contractions with visual feedback.
Exclusion Criteria:
- Shoulder/upper limb fractures or replacement (<12 months), or moderate-severe shoulder osteoarthritis (OA).
- Cervical radiculopathy/myelopathy, peripheral neuropathy, vestibular disorders, or history of stroke/Transient Ischemic Attack (TIA).
- Upper limb pathology (tendinopathy, capsulitis), thoracic outlet syndrome, or fibromyalgia.
- Received neck-specific physiotherapy within the last 3 months.
- Severe osteoporosis, uncontrolled diabetes (HbA1c >9%), or active infection/inflammation.
- Cervical injections or surgery within the last 6 months.
- Inability to follow 2-step instructions.
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 |
|---|---|
|
Experimentální: Experimental Group: Force Control Training
Patients in this group will receive an 8-week cervical force control training program (3 sessions/week).
The training involves submaximal isometric neck contractions using visual feedback via a Handheld Dynamometer, progressing from simple feedback-assisted holds to complex dual-task exercises.
|
An 8-week program (3 sessions/week, 30-40 mins each) utilizing submaximal isometric neck contractions with visual feedback via a Handheld Dynamometer.
The protocol progresses through three phases: initial calibration, acquisition using descending target intensities (25% to 10% MVIC) with continuous visual tracking, and retention/transfer using faded or no feedback combined with dual-tasking (e.g., auditory monitoring or arithmetic).
|
|
Aktivní komparátor: Active Comparator: Conventional Exercise Training
Patients in this group will receive an 8-week conventional exercise program (3 sessions/week).
The program includes standard cervical stretching (upper trapezius and levator scapulae) and scapular strengthening and stabilization exercises.
|
An 8-week program (3 sessions/week, 30 mins each) consisting of standard cervical stretching for the upper trapezius and levator scapulae muscles, alongside scapular strengthening and stabilization exercises (e.g., side-lying external rotation, side-lying forward flexion, prone extension, and push-up plus).
Resistance is tailored based on patient gender and body weight.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cervical Force Sense
Časové okno: Baseline, 8 weeks (immediately post-intervention), and 3-month follow-up
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Assessed using a Handheld Dynamometer (HHD) during force reproduction tasks.
It is measured by calculating the absolute error between a target submaximal force and the reproduced force without visual feedback.
Lower error values indicate better force sense and proprioception.
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Baseline, 8 weeks (immediately post-intervention), and 3-month follow-up
|
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Cervical Force Steadiness
Časové okno: Baseline, 8 weeks (immediately post-intervention), and 3-month follow-up
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Evaluated by calculating the Coefficient of Variation (CoV) of force during submaximal isometric cervical contractions using a Handheld Dynamometer (HHD).
Lower CoV percentages indicate better force steadiness and neuromuscular control.
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Baseline, 8 weeks (immediately post-intervention), and 3-month follow-up
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Neck Functional Disability (Neck Disability Index - NDI)
Časové okno: Baseline, 8 weeks (immediately post-intervention), and 3-month follow-up
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A 10-item patient-completed questionnaire assessing how neck pain affects the ability to manage everyday life activities.
Total scores range from 0 to 50, which can be expressed as a percentage (0-100%).
Higher scores indicate greater patient-rated functional disability.
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Baseline, 8 weeks (immediately post-intervention), and 3-month follow-up
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Pain Intensity (Visual Analogue Scale - VAS)
Časové okno: Baseline, 8 weeks (immediately post-intervention), and 3-month follow-up
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Pain intensity is assessed using a 100-mm horizontal line, anchored by "no pain" at 0 mm and "worst imaginable pain" at 100 mm.
Lower scores indicate a lower level of pain.
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Baseline, 8 weeks (immediately post-intervention), and 3-month follow-up
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12.
- Vaillancourt DE, Slifkin AB, Newell KM. Inter-digit individuation and force variability in the precision grip of young, elderly, and Parkinson's disease participants. Motor Control. 2002 Apr;6(2):113-28. doi: 10.1123/mcj.6.2.113.
- Arvanitidis M, Falla D, Sanderson A, Martinez-Valdes E. Does pain influence control of muscle force? A systematic review and meta-analysis. Eur J Pain. 2025 Feb;29(2):e4716. doi: 10.1002/ejp.4716. Epub 2024 Aug 23.
- Vannebo KT, Iversen VM, Fimland MS, Mork PJ. Test-retest reliability of a handheld dynamometer for measurement of isometric cervical muscle strength. J Back Musculoskelet Rehabil. 2018;31(3):557-565. doi: 10.3233/BMR-170829.
- Zaidi, S., Khan, S. A., Zaki, S., Sundus, H., Alam, M. F., & Nuhmani, S. (2025). Effectiveness of sensorimotor training on pain, cervical joint position sense, range of motion, balance, and disability in chronic neck pain: A systematic review. Heliyon, 11(10), Article e43409.
- Muceli S, Farina D, Kirkesola G, Katch F, Falla D. Reduced force steadiness in women with neck pain and the effect of short term vibration. J Electromyogr Kinesiol. 2011 Apr;21(2):283-90. doi: 10.1016/j.jelekin.2010.11.011. Epub 2010 Dec 30.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
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
- P.T.REC/012/006579
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