- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07629141
Muscle Position and Dry Needling Efficacy
The Importance of Muscle Position in the Effectiveness of Dry Needling Technique
Currently, no previous studies have investigated how the position of a muscle before dry needling may influence the outcome and effectiveness of the treatment.
This study aims to demonstrate whether the position of the upper trapezius muscle during dry needling treatment influences the outcome of that treatment in subjects with neck pain.
A total of 46 participants with chronic neck pain will be recruited and randomly assigned to two groups: a dry needling group with the muscle in a stretched position and a dry needling group with the muscle in a shortened position. A total of two treatment sessions will be performed, separated by a 7-day interval. The primary outcome measure will be the intensity of neck and head pain, measured using the visual analog scale (VAS). Other variables to be measured include the cervical disability index, kinesiophobia, and catastrophizing (using a self-completion questionnaire), as well as participants' expectations and post-needling pain.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Daniel Pecos-Martin, PhD
- Telefonní číslo: 34918855142
- E-mail: daniel.pecos@uah.es
Studijní místa
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Madrid
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Alcalá de Henares, Madrid, Španělsko, 28805
- Physioterapy and Pain center research
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Alcalá de Henares, Madrid, Španělsko, 2805
- Clinical University Physiotherapy and pain
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age between 18 and 65 years
- Neck pain lasting more than 3 months
- Current neck pain greater than 3/10 on the VAS (Visual Analog Scale)
- Presence of active trigger points in the upper trapezius muscle, meeting the following criteria: Painful point within a taut band whose palpation reproduces the patient's symptoms.
Exclusion Criteria:
- Neck pain with a medical diagnosis (fractures, arthritis, fibromyalgia, etc.)
- Radicular pain (paresthesia, burning, electric shocks)
- Whiplash or any recent trauma
- Previous surgery
- Treatment by another physiotherapist within the last 3 months
- Infections
- Needle phobia
- Use of anticoagulant medications
- Pregnancy
- Fibromyalgia
- Metal allergies
- Cognitive deficits or communication problems
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Upper trapezius dry needling with adduction shoulder
The dry needling technique will be applied to the trapezius muscle while the subject lies prone, with the upper limb at the side of the body, shoulder lowered, in adduction and cervical region in a neutral position. The dry needling technique will be applied using a pincer grasp, inserting the needle from the posterior to the anterior portion of the upper trapezius muscle. |
Ten incisions will be made in a posteroanterior direction while the patient lies prone and the muscle is grasped with a pincer grip between the first three fingers.
The technique will be applied to the area that is mechanically most hyperalgesic and related to the reproduction of the patient's pain.
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Experimentální: Upper trapezius dry needling with 90º abduction shoulder
The dry needling technique will be applied to the trapezius muscle while the subject lies prone, with the upper limb separated from the body, shoulder at 90 degrees of abduction and cervical region in a neutral position. The dry needling technique will be applied using a pincer grasp, inserting the needle from the posterior to the anterior portion of the upper trapezius muscle. |
Ten incisions will be made in a posteroanterior direction while the patient lies prone and the muscle is grasped with a pincer grip between the first three fingers.
The technique will be applied to the area that is mechanically most hyperalgesic and related to the reproduction of the patient's pain.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The visual analog scale (VAS)
Časové okno: Change from baseline at 3 months
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Intensity of neck and head pain: This was measured using the visual analog scale (VAS).
It consists of a 10 cm horizontal line, where 0 cm on the left side represents "no pain" and 10 cm on the right side represents "maximum pain."
The subject marks a perpendicular line at the point they consider to represent their pain intensity.
The examiner then places a millimeter ruler on the scale, assigning a numerical value to the line drawn by the patient.
The VAS has proven to be a valid and reliable tool (intraclass correlation coefficient [ICC] 0.71-0.99).
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Change from baseline at 3 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Disability Associated with Neck Pain
Časové okno: Change from baseline at 3 months
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The degree of disability associated with neck pain will be measured using the Neck Disability Index (NDI) questionnaire in its Spanish version.
The NDI is a 10-item questionnaire, and each item is scored on a scale of 0 to 5 points, with a range of 0 to 50 points.
The higher the score, the greater the degree of disability.
The NDI has proven to be a reliable tool (ICC 0.98).
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Change from baseline at 3 months
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Kinesiophobia with the Tampa Kinesiophobia Scale (TSK-11)
Časové okno: Change from baseline at 3 months
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The Tampa Kinesiophobia Scale (TSK-11) short version will be used to assess fear of movement.
It is an 11-item scale rated on a four-point scale ranging from "strongly agree" to "strongly disagree."
Scores range from 11 to 44, with higher scores indicating greater fear of movement and/or (re)injury.
This questionnaire has demonstrated similar properties to the original TSK scale, proving to be a valid and reliable instrument.
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Change from baseline at 3 months
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Catastrophizing with the Pain Catastrophizing Scale (PCS)
Časové okno: Change from baseline at 3 months
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Catastrophizing Scale (PCS).
The PCS has 13 items scored from 0 to 4 and is composed of three subscales: rumination, magnification, and helplessness.
The overall score ranges from 0 to 52.
Higher scores indicate a greater degree of pain catastrophizing.
A total score >30 represents a clinically significant level of pain catastrophizing.
This questionnaire has been shown to be reliable (ICC 0.94).
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Change from baseline at 3 months
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Local twitch response (LTRs)
Časové okno: Change from baseline at 3 months
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Local twitch response (LTRs).
The LTRs produced by needle insertion during dry needling will be counted.
LTRs are generally associated with better treatment outcomes.
A higher number of LTRs indicates better results, and a lower number of LTRs indicates worse results.
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Change from baseline at 3 months
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Cervical joint Range
Časové okno: Change from baseline mobility at one week after intervention
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Flexion, inclination, extension and rotational movement ranges will be measured with a cervical goniometer
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Change from baseline mobility at one week after intervention
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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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