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
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Burim Peli
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change in Headache Impact Test (HIT-6) total score
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr
OMT
干预措施: Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr (Other)
Participants in this group will receive standard physiotherapy treatment including therapeutic exerc
conventional physiotherapy
干预措施: conventional physiotherapy (Other)
结局指标
主要结局
Mean change in Headache Impact Test (HIT-6) total score
时间窗: Baseline and Week 4
Mean change in HIT-6 total score from baseline to Week 4. Higher scores indicate greater headache impact.
Mean change in Dizziness Handicap Inventory (DHI) total score
时间窗: Baseline and Week 4
The DHI is a 25-item questionnaire assessing dizziness-related disability (score range: 0-100). Mean change from baseline to Week 4 will be calculated.
Mean change in Neck Disability Index (NDI) total score
时间窗: Baseline and Week 4
The NDI assesses neck-related disability (score range: 0-50). Mean change from baseline to Week 4 will be calculated.
Mean change in Perceived Stress Scale (PSS-10) total score
时间窗: Baseline and Week 4
Mean change in PSS-10 total score from baseline to Week 4. Higher scores indicate greater perceived stress.
次要结局
- Mean change in Numeric Rating Scale (NRS) score for neck pain(Baseline and Week 4)
- Mean change in Numeric Rating Scale (NRS) score for headache intensity(Baseline and Week 4)
- Mean change in Tampa Scale of Kinesiophobia (TSK) total score(Baseline and Week 4)
- Mean change in Pain Catastrophizing Scale (PCS) total score(Baseline and Week 4)
- Mean change in cervical range of motion (degrees)(Baseline and Week 4)
- Mean change in Flexion-Rotation Test (FRT) range (degrees)(Baseline and Week 4)
研究者
Burim Peli
International Osteopathic Academy, Milan
International Osteopathic Academy, Milan