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Osteopathic Manipulative Treatment vs Physiotherapy in Cervicocranial Dysfunction

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07555873
Acronym
OMT-CCD
Enrollment
50
Registered
2026-04-29
Start date
2026-05-01
Completion date
2026-09-30
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervicocranial Dysfunction, Cervicogenic Headache, Dizziness, Neck Pain Musculoskeletal

Keywords

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

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.

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.

Interventions

OTHERParticipants 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

OTHERconventional physiotherapy

physiotherapy

Sponsors

Burim Peli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean change in Headache Impact Test (HIT-6) total scoreBaseline and Week 4Mean 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 scoreBaseline and Week 4The 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 scoreBaseline and Week 4The 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 scoreBaseline and Week 4Mean change in PSS-10 total score from baseline to Week 4. Higher scores indicate greater perceived stress.

Secondary

MeasureTime frameDescription
Mean change in Numeric Rating Scale (NRS) score for neck painBaseline and Week 4Mean 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.
Mean change in Numeric Rating Scale (NRS) score for headache intensityBaseline and Week 4Mean change in headache intensity measured using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) from baseline to Week 4.
Mean change in Tampa Scale of Kinesiophobia (TSK) total scoreBaseline and Week 4Mean change in fear of movement measured using the TSK total score from baseline to Week 4. Higher scores indicate greater kinesiophobia.
Mean change in Pain Catastrophizing Scale (PCS) total scoreBaseline and Week 4Mean change in pain catastrophizing measured using the PCS total score from baseline to Week 4. Higher scores indicate greater catastrophizing.
Mean change in cervical range of motion (degrees)Baseline and Week 4Mean change in active cervical range of motion (flexion, extension, rotation, lateral flexion) measured in degrees using a goniometer from baseline to Week 4.
Mean change in Flexion-Rotation Test (FRT) range (degrees)Baseline and Week 4Mean change in upper cervical rotation range measured using the Flexion-Rotation Test (FRT) in degrees from baseline to Week 4.

Countries

Kosovo

Contacts

CONTACTBurim Peli, Phd cand.
burimpeli@hotmail.com+38349600053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026