Cervicogenic HeadacheOMT-CCDNCT07555873
Osteopathic Manipulative Treatment vs Physiotherapy in Cervicocranial Dysfunction
A study testing Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr and conventional physiotherapy in people with Cervicogenic Headache and Dizziness, run by Burim Peli at 1 site in Kosovo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervicogenic Headache, Dizziness, Neck Pain Musculoskeletal
- What is being tested?
- Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteKosovo
- Study dates
- 1 May 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kosovo1 site, 1 recruiting
- Recruiting
Imperium Medical Clinic
Pristina, Pejton, 30000
Burim Peli Peli Burim, MSc physiotherapy, Phd Cand,, +38349600053, burimpeli@hotmail.com
About this study
Official 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
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.
Read the 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.
- Being tested
- Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr, conventional physiotherapy
- Keywords
- osteopathic manipulation treatmant, manual therapy, physiotherapy, RCT, cervicogenic headache, dizziness rehabilitation
- Medical subject headings
- Post-Traumatic Headache, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocrOther
Conventional physiotherapy including therapeutic exercises, manual therapy, and physical modalities such as TENS and heat therapy
conventional physiotherapyOther
physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr | Experimental | OMT Receives: 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 Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 4
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burim Peli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burim Peli, International Osteopathic Academy, Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555873
- Sponsor's protocol ID
- IOA-CCD-2026
- Acronym
- OMT-CCD
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be shared due to confidentiality and ethical restrictions related to patient data protection.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07555873
- Acronym / sponsor ID
- OMT-CCD / IOA-CCD-2026
- Keywords
- osteopathic manipulation treatmant, manual therapy, physiotherapy, RCT, cervicogenic headache, dizziness rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Burim PeliUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr | Experimental | Other: Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocrOMT |
| Participants in this group will receive standard physiotherapy treatment including therapeutic exerc | Active comparator | Other: conventional physiotherapyconventional physiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants will be eligible for inclusion in the study if they meet the following criteria:
Key exclusion criteria (8 listed)
- Participants will be excluded from the study if they present with any of the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocrConventional physiotherapy including therapeutic exercises, manual therapy, and physical modalities such as TENS and heat therapy | Other | Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr |
| conventional physiotherapyphysiotherapy | Other | Participants in this group will receive standard physiotherapy treatment including therapeutic exerc |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
Mean change in Numeric Rating Scale (NRS) score for neck pain
Time frame: Baseline and Week 4
Mean change in Numeric Rating Scale (NRS) score for headache intensity
Time frame: Baseline and Week 4
Mean change in Tampa Scale of Kinesiophobia (TSK) total score
Time frame: Baseline and Week 4
Mean change in Pain Catastrophizing Scale (PCS) total score
Time frame: Baseline and Week 4
Mean change in cervical range of motion (degrees)
Time frame: Baseline and Week 4
Mean change in Flexion-Rotation Test (FRT) range (degrees)
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be shared due to confidentiality and ethical restrictions related to patient data protection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr and conventional physiotherapy in people with Cervicogenic Headache and Dizziness, run by Burim Peli at 1 site in Kosovo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kosovo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burim Peli, Phd cand. (+38349600053, burimpeli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Headache Impact Test (HIT-6) total score (time frame: Baseline and Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.