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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr | Experimental | OMT |
|
| Participants in this group will receive standard physiotherapy treatment including therapeutic exerc | Active Comparator | conventional physiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr | Other | Conventional physiotherapy including therapeutic exercises, manual therapy, and physical modalities such as TENS and heat therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Headache Impact Test (HIT-6) total score | Mean change in HIT-6 total score from baseline to Week 4. Higher scores indicate greater headache impact. | Baseline and Week 4 |
| Mean change in Dizziness Handicap Inventory (DHI) total score | 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. | Baseline and Week 4 |
| Mean change in Neck Disability Index (NDI) total score | The NDI assesses neck-related disability (score range: 0-50). Mean change from baseline to Week 4 will be calculated. | Baseline and Week 4 |
| Mean change in Perceived Stress Scale (PSS-10) total score | Mean change in PSS-10 total score from baseline to Week 4. Higher scores indicate greater perceived stress. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Numeric Rating Scale (NRS) score for neck pain | Mean change in neck pain intensity measured using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) from baseline to Week 4. | Baseline and Week 4 |
| Mean change in Numeric Rating Scale (NRS) score for headache intensity |
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Inclusion Criteria:
Participants will be eligible for inclusion in the study if they meet the following criteria:
Exclusion Criteria:
Participants will be excluded from the study if they present with any of the following conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Burim Peli, Phd cand. | Contact | +38349600053 | burimpeli@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperium Medical Clinic | Recruiting | Pristina | Pejton | 30000 | Kosovo |
Individual participant data (IPD) will not be shared due to confidentiality and ethical restrictions related to patient data protection.
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| conventional physiotherapy | Other | physiotherapy |
|
Mean change in headache intensity measured using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) from baseline to Week 4. |
| Baseline and Week 4 |
| Mean change in Tampa Scale of Kinesiophobia (TSK) total score | Mean change in fear of movement measured using the TSK total score from baseline to Week 4. Higher scores indicate greater kinesiophobia. | Baseline and Week 4 |
| Mean change in Pain Catastrophizing Scale (PCS) total score | Mean change in pain catastrophizing measured using the PCS total score from baseline to Week 4. Higher scores indicate greater catastrophizing. | Baseline and Week 4 |
| Mean change in cervical range of motion (degrees) | Mean change in active cervical range of motion (flexion, extension, rotation, lateral flexion) measured in degrees using a goniometer from baseline to Week 4. | Baseline and Week 4 |
| Mean change in Flexion-Rotation Test (FRT) range (degrees) | Mean change in upper cervical rotation range measured using the Flexion-Rotation Test (FRT) in degrees from baseline to Week 4. | Baseline and Week 4 |
| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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