Osteopathic Manipulative Treatment vs Physiotherapy in Cervicocranial Dysfunction

Официальное название

Comparative Effects of Osteopathic Manipulative Treatment and Standard Physiotherapy on Dizziness, Headache Impact, Neck Disability, and Psychological Stress in Patients With Cervicocranial Dysfunction: A Randomized Controlled Trial

Обзор

This study aims to compare the effects of osteopathic manipulative treatment and standard physiotherapy in patients with cervicocranial dysfunction. The study will evaluate outcomes including dizziness, headache impact, neck disability, and psychological stress. Participants will be randomly assigned to one of two groups: osteopathic treatment or standard physiotherapy. The interventions will be applied over a defined treatment period, and outcomes will be measured before and after the intervention. The purpose of this study is to determine which approach is more effective in improving symptoms and functional outcomes in patients with cervicocranial dysfunction.

Подробное описание

Cervicocranial dysfunction is commonly associated with symptoms such as dizziness, headache, neck pain, and psychological stress, which significantly affect patients' quality of life. Various therapeutic approaches are used in clinical practice, including osteopathic manipulative treatment (OMT) and standard physiotherapy; however, comparative evidence between these approaches remains limited.

This randomized controlled trial aims to evaluate the comparative effectiveness of osteopathic manipulative treatment versus standard physiotherapy in patients diagnosed with cervicocranial dysfunction. Participants will be randomly allocated into two groups. The experimental group will receive osteopathic manipulative treatment, while the control group will receive standard physiotherapy interventions.

Outcome measures will include dizziness intensity, headache impact, neck disability index, and psychological stress levels. Assessments will be conducted at baseline and after completion of the intervention period.

The results of this study are expected to provide evidence regarding the effectiveness of osteopathic treatment compared to conventional physiotherapy and contribute to improving clinical decision-making in the management of cervicocranial dysfunction.

Вмешательства

• Другое Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr
  Conventional physiotherapy including therapeutic exercises, manual therapy, and physical modalities such as TENS and heat therapy
• Другое conventional physiotherapy
  physiotherapy

Первичные конечные точки

• Mean change in Headache Impact Test (HIT-6) total score [Срок оценки: Baseline and Week 4]
• Mean change in Dizziness Handicap Inventory (DHI) total score [Срок оценки: Baseline and Week 4]
• Mean change in Neck Disability Index (NDI) total score [Срок оценки: Baseline and Week 4]
• Mean change in Perceived Stress Scale (PSS-10) total score [Срок оценки: Baseline and Week 4]

Вторичные конечные точки (6)

• Mean change in Numeric Rating Scale (NRS) score for neck pain [Срок оценки: Baseline and Week 4]
• Mean change in Numeric Rating Scale (NRS) score for headache intensity [Срок оценки: Baseline and Week 4]
• Mean change in Tampa Scale of Kinesiophobia (TSK) total score [Срок оценки: Baseline and Week 4]
• Mean change in Pain Catastrophizing Scale (PCS) total score [Срок оценки: Baseline and Week 4]
• Mean change in cervical range of motion (degrees) [Срок оценки: Baseline and Week 4]
• Mean change in Flexion-Rotation Test (FRT) range (degrees) [Срок оценки: Baseline and Week 4]

Критерии участия

Критерии включения

• Participants will be eligible for inclusion in the study if they meet the following criteria:

• Age between 18 and 65 years.
• Presence of cervicocranial symptoms for at least three months, indicating a chronic condition.
• Neck pain with or without associated headache.
• Dizziness associated with neck movement or cervical position.
• Clinical findings consistent with cervicocranial dysfunction, based on clinical examination.
• Ability to understand and complete standardized clinical questionnaires used in the study.
• Willingness to participate in the study and provision of written informed consent.

Критерии исключения

• Participants will be excluded from the study if they present with any of the following conditions:

• Clinically confirmed vestibular disorders.
• Central neurological disorders that may influence dizziness or balance.
• Recent severe trauma to the cervical spine.
• History of cervical spine surgery.
• Systemic inflammatory diseases or serious spinal pathologies.
• Presence of red flags related to the cervical spine identified during clinical screening.
• Participation in concurrent intensive physiotherapy or rehabilitation treatment during the study period.

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

Открытое

Основная цель

Лечение

Центры проведения

Kosovo · 1 центр

• Imperium Medical Clinic — Pristina

Идентификаторы

NCT: NCT07555873 · IOA-CCD-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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