Effectiveness of Manual Therapy in the Treatment of Attention Deficit Hyperactivity Disorder

Обзор

The main objective is to determine whether Manual Therapy (MT), in addition to conventional treatment, is more effective in improving ADHD symptoms than the application of conventional treatment alone.

Подробное описание

Background ADHD is a disorder that affects attention, behavior control, and emotions in children. Although medication and behavioral therapy can help, not all children respond well or may experience side effects, which leads to the search for alternative options. This disorder affects the daily lives of both the child and their family, and in adulthood, it can cause emotional, social, and work-related problems. Treatment usually includes medication, cognitive-behavioral therapy, parent training, and techniques such as mindfulness. A newer option is manual therapy (MT), which uses massage and craniosacral therapy to support the nervous system and improve emotional and behavioral regulation. Although some studies have shown promising results, more research is needed to confirm its effectiveness.

Materials and Methods: A randomized clinical trial will be conducted. The minimum sample size required for statistical significance is 60 subjects, divided into two groups with 30 participants each. The primary variable will be hyperactivity and attention deficit, assessed using the Conners Parent Rating Scale and the Conners Teacher Rating Scale. The secondary variable will be mood, measured using a facial expression scale.

Objetives To determine whether the addition of manual therapy to conventional treatment is more effective in improving ADHD symptoms than conventional treatment alone.

Вмешательства

• Процедура Procedure: craniosacral therapy techniques.
  Participants in the experimental group will receive Manual Therapy (MT) designed for this study, which will include craniosacral therapy techniques. The sessions will last 40 minutes and will be conducted twice a week for the first 4 weeks, followed by once a week for the final 4 weeks.
• Процедура Placebo Group
  The placebo group will receive a dummy treatment with a duration of 40min, twice a week for the firt 4 week, follwed by once a week for the final 4 week.

Первичные конечные точки

• Symptoms of ADHD (Parents Rating Scale) [Срок оценки: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).]
• Symptoms of ADHD (Teacher Rating Scale) [Срок оценки: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).]

Вторичные конечные точки (1)

• Mood [Срок оценки: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).]

Критерии участия

Критерии включения

• Confirmed ADHD diagnosis according to DSM-5 criteria.
• Children and adolescents aged 6 to 12 years.
• Availability to attend all Manual Therapy (MT) sessions.
• Informed consent signed by legal guardians.

Критерии исключения

• Severe concomitant psychiatric or neurological disorders (e.g., epilepsy, severe autism spectrum disorder, schizophrenia).
• Medical conditions that contraindicate MT (e.g., fractures, severe scoliosis, connective tissue diseases).
• Recent use of or changes in ADHD medication within the past 4 weeks.
• Simultaneous participation in other interventional studies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla, Sevilla, Spa — Alcalá de Henares

Публикации

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• Accorsi A, Lucci C, Di Mattia L, Granchelli C, Barlafante G, Fini F, Pizzolorusso G, Cerritelli F, Pincherle M. Effect of osteopathic manipulative therapy in the attentive performance of children with attention-deficit/hyperactivity disorder. J Am Osteopath Assoc. 2014 May;114(5):374-81. doi: 10.7556/jaoa.2014.074. PMID 24778002
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• Crouzet L, Gramond A, Suehs C, Fabbro-Peray P, Abbar M, Lopez-Castroman J. Third-generation cognitive behavioral therapy versus treatment-as-usual for attention deficit and hyperactivity disorder: a multicenter randomized controlled trial. Trials. 2022 Jan 28;23(1):83. doi: 10.1186/s13063-021-05983-2. PMID 35090544
• Bellato A, Arora I, Hollis C, Groom MJ. Is autonomic nervous system function atypical in attention deficit hyperactivity disorder (ADHD)? A systematic review of the evidence. Neurosci Biobehav Rev. 2020 Jan;108:182-206. doi: 10.1016/j.neubiorev.2019.11.001. Epub 2019 Nov 10. PMID 31722229
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• Robertz AC, Tornhage CJ, Nilsson S, Nyman V, Kantzer AK. Positive effects of tactile massage for adolescents with Attention Deficit/Hyperactivity Disorder (ADHD) - A small scale study. Complement Ther Clin Pract. 2024 Nov;57:101909. doi: 10.1016/j.ctcp.2024.101909. Epub 2024 Sep 25. PMID 39332064
• Musser ED, Backs RW, Schmitt CF, Ablow JC, Measelle JR, Nigg JT. Emotion regulation via the autonomic nervous system in children with attention-deficit/hyperactivity disorder (ADHD). J Abnorm Child Psychol. 2011 Aug;39(6):841-52. doi: 10.1007/s10802-011-9499-1. PMID 21394506

Идентификаторы

NCT: NCT07029425 · USeville-PFB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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