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NCT Number: NCT07555873

Osteopathic Manipulative Treatment vs Physiotherapy in Cervicocranial Dysfunction

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.

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Key information

Conditions

Cervicogenic Headache Brain Diseases Central Nervous System Diseases Cervicocranial Dysfunction Dizziness Headache Disorders Headache Disorders, Secondary Neck Pain Musculoskeletal Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Post-Traumatic Headache Sensation Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperium Medical Clinic

Pristina, Pejton, 30000, Kosovo

Location status: Recruiting

Location contact

Burim Peli Peli Burim, MSc physiotherapy, Phd Cand,

CONTACT

[email protected]

+38349600053

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Conventional Physiotherapy

Other

physiotherapy

Primary outcomes

  1. Mean change in Headache Impact Test (HIT-6) total score

    Time frame: Baseline and Week 4

    Mean change in HIT-6 total score from baseline to Week 4. Higher scores indicate greater headache impact.

  2. Mean change in Dizziness Handicap Inventory (DHI) total score

    Time frame: 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.

  3. Mean change in Neck Disability Index (NDI) total score

    Time frame: Baseline and Week 4

    The NDI assesses neck-related disability (score range: 0-50). Mean change from baseline to Week 4 will be calculated.

  4. Mean change in Perceived Stress Scale (PSS-10) total score

    Time frame: Baseline and Week 4

    Mean change in PSS-10 total score from baseline to Week 4. Higher scores indicate greater perceived stress.

Secondary outcomes

  1. Mean change in Numeric Rating Scale (NRS) score for neck pain

    Time frame: Baseline and Week 4

    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.

  2. Mean change in Numeric Rating Scale (NRS) score for headache intensity

    Time frame: Baseline and Week 4

    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.

  3. Mean change in Tampa Scale of Kinesiophobia (TSK) total score

    Time frame: Baseline and Week 4

    Mean change in fear of movement measured using the TSK total score from baseline to Week 4. Higher scores indicate greater kinesiophobia.

  4. Mean change in Pain Catastrophizing Scale (PCS) total score

    Time frame: Baseline and Week 4

    Mean change in pain catastrophizing measured using the PCS total score from baseline to Week 4. Higher scores indicate greater catastrophizing.

  5. Mean change in cervical range of motion (degrees)

    Time frame: Baseline and Week 4

    Mean change in active cervical range of motion (flexion, extension, rotation, lateral flexion) measured in degrees using a goniometer from baseline to Week 4.

  6. Mean change in Flexion-Rotation Test (FRT) range (degrees)

    Time frame: Baseline and Week 4

    Mean change in upper cervical rotation range measured using the Flexion-Rotation Test (FRT) in degrees from baseline to Week 4.

Study contacts

Contact information is provided by the study sponsor or research team.

Burim Peli, Phd cand.

CONTACT

[email protected]

+38349600053

Sponsors and collaborators

Lead sponsor

Burim Peli

Other

Registry information

Official study title

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

Acronym: OMT-CCD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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