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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

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

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Imperium Medical Clinic
    Pristina, Pejton 30000, Kosovo
    Recruiting
07

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.

08

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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