Osteopathic Manipulative Treatment vs Physiotherapy in Cervicocranial Dysfunction (OMT-CCD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dizziness; Cervicogenic Headache; Neck Pain Musculoskeletal; Cervicocranial Dysfunction
• Intervention / Treatment: Other: Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr; Other: conventional physiotherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burim Peli, Phd cand.; Phone Number: +38349600053; Email: burimpeli@hotmail.com

Study Locations

• Kosovo
  • Pejton
    • Pristina, Pejton, Kosovo, 30000
      • Recruiting
      • Imperium Medical Clinic
      • Contact: Burim Peli Peli Burim, MSc physiotherapy, Phd Cand,; Phone Number: +38349600053; Email: burimpeli@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr; OMT	Other: 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
Active Comparator: Participants in this group will receive standard physiotherapy treatment including therapeutic exerc; conventional physiotherapy	Other: conventional physiotherapy; physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Burim Peli

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: RCT; manual therapy; physiotherapy; cervicogenic headache; osteopathic manipulation treatmant; dizziness rehabilitation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Sensation Disorders; Headache Disorders, Secondary; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dizziness; Post-Traumatic Headache
• Other Study ID Numbers: IOA-CCD-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) will not be shared due to confidentiality and ethical restrictions related to patient data protection.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No