Osteopathic Manipulative Treatment vs Physiotherapy in Cervicocranial Dysfunction

NCT07555873 | Recruiting

• 1 other identifier: IOA-CCD-2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervicogenic Headache; Dizziness; Neck Pain Musculoskeletal; Cervicocranial Dysfunction

Keywords

osteopathic manipulation treatmant; manual therapy; physiotherapy; RCT; cervicogenic headache; dizziness rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr

EXPERIMENTAL

OMT

Other: Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr

Participants in this group will receive standard physiotherapy treatment including therapeutic exerc

ACTIVE COMPARATOR

conventional physiotherapy

Other: conventional physiotherapy

Interventions

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

Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr

conventional physiotherapy OTHER

physiotherapy

Participants in this group will receive standard physiotherapy treatment including therapeutic exerc

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burim Peli: lead

Study Sites (1)

Imperium Medical Clinic

Pristina, Pejton, 30000, Kosovo

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache; Dizziness

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Burim Peli, Phd cand.

CONTACT

+38349600053; burimpeli@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: International Osteopathic Academy, Milan

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

KO (1)