Comparative Effects of Kinesio Taping on Cervical Pain in Climacteric Women (KT-Cerv-W)
Comparative Study on the Effect of Kinesio Taping in Climacteric Women With Nonspecific Cervical Pain: ARandomized Clinical Trial.
This randomized controlled clinical trial aims to evaluate the effects of neuromuscular taping on cervical pain and health-related quality of life in climacteric women with non-specific chronic neck pain. Two taping techniques ("Y-strip" and "star-shape") will be compared with a control group receiving no intervention.
Participants will be randomly allocated to one of three groups following concealed allocation. The interventions will be applied to the cervicodorsal region (centered at C7) by an experienced physiotherapist over a 3-week period, with taping changes performed weekly. A 4-week total follow-up period will be included.
Primary and secondary outcomes will assess pain intensity, pressure pain threshold, cervical disability, cranio-cervical angle, pain perception, body satisfaction, and health-related quality of life. Measurements will be collected at baseline, weekly during the intervention, and at one-week post-intervention follow-up.
The study is designed to provide evidence on the effectiveness and feasibility of two non-invasive neuromuscular taping approaches in the management of chronic non-specific cervical pain in middle-aged women.
Přehled studie
Postavení
Detailní popis
This randomized controlled clinical trial is designed to investigate the effects of neuromuscular taping on pain, functional outcomes, and health-related quality of life in climacteric women with non-specific chronic cervical pain. The study compares two different neuromuscular taping applications ("Y-strip" and "star-shape") with a no-intervention control group.
Eligible participants will be women aged 45-65 years with non-specific cervical pain lasting more than three months, presenting mechanical pain characteristics and without clinical signs of specific pathology. After screening and baseline assessment, participants will be randomly allocated to one of the three study groups using a computer-generated randomization sequence with allocation concealment via sealed opaque envelopes.
Interventions will be applied to the cervicodorsal region, centered at the C7 vertebra, by an experienced physiotherapist following standardized protocols. The "Y-strip" technique will target the posterior cervical extensor muscles with directional and cross-taping components, while the "star-shape" technique will consist of four I-strips applied in a radial configuration over the cervicodorsal region. Tape will be replaced every 7 days during a 3-week intervention period. Participants in the control group will continue their usual daily activities without intervention.
Outcome measures will be assessed at five time points: baseline, week 1, week 2, week 3, and one-week post-intervention follow-up (week 4). The primary outcome is cervical pain intensity measured using an 11-point Numerical Rating Scale. Secondary outcomes include pressure pain threshold (measured in cervical and suboccipital muscles using algometry), cranio-cervical angle (assessed in seated and standing positions), neck disability (Neck Disability Index), pain perception (McGill Pain Questionnaire), body satisfaction and self-perception, and health-related quality of life (SF-8 Health Survey).
Pressure pain threshold data will be obtained through three repeated measurements per site and averaged for analysis, including a composite bilateral muscle score. The SF-8 will provide physical and mental component summaries of health status.
The study will employ a blinded outcome assessor, intention-to-treat analysis, and standardized measurement procedures. Participants will be blinded to group allocation, and medication use will not be restricted, although it will be recorded throughout the study period.
This trial aims to provide high-quality evidence regarding the clinical effectiveness of neuromuscular taping as a conservative intervention for chronic non-specific cervical pain and to determine whether different taping configurations produce differential therapeutic effects.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Gemma Victoria Espi Lopez, PhD
- Telefonní číslo: +34651948635
- E-mail: gemma.espi@uv.es
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Female participants aged 45-65 years Non-specific musculoskeletal or osteoarticular cervical pain lasting more than 3 months Mechanical neck pain characteristics (pain influenced by movement or posture; absence of persistent non-mechanical nocturnal pain) Ability to understand the study procedures and provide written informed consent No clinical history or signs suggestive of specific cervical pathology
Exclusion Criteria:
Presence of any red flags Recent cervical trauma History of cancer or presence of constitutional symptoms (e.g., unexplained weight loss, fever, systemic malaise) Signs of infection or immunosuppression-related pain Active inflammatory disease Suspected vascular origin of symptoms (e.g., vertigo with cervical rotation, diplopia, dysarthria, vertebrobasilar symptoms, arterial dissection signs) Severe neurological involvement (e.g., progressive radiculopathy or signs of myelopathy) Relevant findings in previous imaging studies attributable to pain (routine imaging not required; only existing studies will be reviewed) Cervical surgery within the past 12 months Severe systemic diseases affecting the musculoskeletal system
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: Skupina 3
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Experimentální: Arm 1
Participants will be allocated to neuromuscular taping using a "Y-strip" configuration applied to the cervicodorsal region.
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Neuromuscular taping will be applied over the cervicodorsal region centered at C7.
A Y-shaped tape will be placed over the posterior cervical extensor muscles with approximately 15-25% tension, plus an additional perpendicular I-strip over the mid-cervical region (C3-C6).
Application will be performed in specific cervical positions to optimize muscle targeting.
The tape will be replaced every 7 days.
The intervention period will last 3 weeks, followed by 1 week of follow-up without intervention.
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Experimentální: Arm 2
Participants will be allocated to neuromuscular taping using a "star-shape" configuration applied to the cervicodorsal region.
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Neuromuscular taping will be applied over the cervicodorsal region centered at C7. Four I-strips will be placed with approximately 25% tension forming a star-shaped configuration over the treatment area.
The tape will be replaced every 7 days.
The intervention period will last 3 weeks, followed by 1 week of follow-up without intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cervical pain intensity
Časové okno: Baseline, week 1, week 2, week 3, and week 4 (follow-up)
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Cervical pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst imaginable pain.
Participants will rate their average cervical pain over the previous week.
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Baseline, week 1, week 2, week 3, and week 4 (follow-up)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pressure pain threshold (PPT)
Časové okno: Baseline, week 1, week 2, week 3, and week 4 (follow-up)
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Pressure pain threshold will be measured bilaterally in the upper trapezius, levator scapulae, and suboccipital muscles using a digital algometer (Wagner FDK 20).
Three measurements per site will be recorded and averaged.
A composite score will be calculated.
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Baseline, week 1, week 2, week 3, and week 4 (follow-up)
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Cranio-cervical angle
Časové okno: Baseline, week 3, and week 4 (follow-up)
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The cranio-cervical angle will be measured in seated and standing positions as the angle between a line from C7 to the tragus and a horizontal reference line through C7.
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Baseline, week 3, and week 4 (follow-up)
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Neck disability
Časové okno: Baseline, week 3, and week 4 (follow-up)
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The Neck Disability Index (NDI) is a 10-item questionnaire assessing self-reported disability related to cervical pain.
Higher scores indicate greater disability.
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Baseline, week 3, and week 4 (follow-up)
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Pain perception
Časové okno: Baseline, week 3, and week 4 (follow-up)
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McGill Pain Questionnaire (short form).
Pain perception will be assessed using the short-form McGill Pain Questionnaire, including Pain Rating Index (PRI), Present Pain Intensity (PPI), Number of Words Chosen (NWC), and Visual Analog Scale (VAS).
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Baseline, week 3, and week 4 (follow-up)
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Body satisfaction and self-perception
Časové okno: Baseline, week 3, and week 4 (follow-up)
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Body Satisfaction and Global Self-Perception Questionnaire (QSCPGSe).
This questionnaire evaluates vitality, aesthetic perception, cognitive discomfort, and affective discomfort.
Higher scores indicate greater body satisfaction.
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Baseline, week 3, and week 4 (follow-up)
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Health-related quality of life
Časové okno: Baseline, week 3, and week 4 (follow-up)
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SF-8 Health Survey.
The SF-8 assesses eight domains of health-related quality of life (general health, physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, and mental health).
Physical (PCS) and mental (MCS) summary scores will be derived.
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Baseline, week 3, and week 4 (follow-up)
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Spolupracovníci a vyšetřovatelé
Sponzor
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
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