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RecruitingNCT07555873OMT-CCDUpdated Apr 29, 2026

Osteopathic Manipulative Treatment vs Physiotherapy in Cervicocranial Dysfunction

An interventional study of Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr and conventional physiotherapy in Cervicogenic Headache, Dizziness and Neck Pain Musculoskeletal, sponsored by Burim Peli. Recruiting at 1 site in Kosovo. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Burim Peli · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cervicogenic Headache
  • Dizziness
  • Neck Pain Musculoskeletal
  • Cervicocranial Dysfunction

Keywords

  • osteopathic manipulation treatmant
  • manual therapy
  • physiotherapy
  • RCT
  • cervicogenic headache
  • dizziness rehabilitation
03

In context

Post-Traumatic Headache

192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.

This study's planned enrollment of 50 is above the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.

Browse Post-Traumatic Headache studies →

Lead sponsor

This is the only study on the registry with Burim Peli as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

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

    conventional physiotherapy

    Other: conventional physiotherapy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Week 4

  2. 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.

    Time frame: Baseline and Week 4

  3. 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.

    Time frame: Baseline and Week 4

  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.

    Time frame: Baseline and Week 4

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 4

  2. 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.

    Time frame: Baseline and Week 4

  3. 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.

    Time frame: Baseline and Week 4

  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.

    Time frame: Baseline and Week 4

  5. 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.

    Time frame: Baseline and Week 4

  6. 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.

    Time frame: Baseline and Week 4

07

Study locations

1 of 1 sites recruiting
  • Imperium Medical Clinic
    Pristina, Pejton 30000, Kosovo
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Individual participant data (IPD) will not be shared due to confidentiality and ethical restrictions related to patient data protection.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2026; primary completion for Jun 2026, 1 month later.

Of 89 non-industry interventional studies with no phase under Post-Traumatic Headache, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 1 month is below that.

Counting every sponsor, half of 90 studies reached it within 12 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2026
First posted
Apr 29, 2026
StartEst.
May 1, 2026
Primary completionEst.
Jun 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07555873
Lead sponsor
Burim Peli
Responsible party
Burim Peli (International Osteopathic Academy, Milan, International Osteopathic Academy, Milan) — Sponsor-investigator
First posted
Apr 29, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Apr 29, 2026

Study contacts

Burim Peli, Phd cand.
Contact
burimpeli@hotmail.com
+38349600053

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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