Osteopathic Manipulative Treatment vs Physiotherapy in Cervicocranial Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBurim Peli
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocr
Other interventionConventional physiotherapy including therapeutic exercises, manual therapy, and physical modalities such as TENS and heat therapy
conventional physiotherapy
Other interventionphysiotherapy
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Participants in this group will receive osteopathic manipulative treatment (OMT) targeting cervicocrExperimental treatment 1 intervention
Group B: Participants in this group will receive standard physiotherapy treatment including therapeutic exercActive comparator 1 intervention
Trial outcomes
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 42
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 43
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 44
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 4Secondary 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 42
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 43
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 44
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 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Burim Peli
Lead sponsor
International Osteopathic Academy, Milan
Sponsor institution
Source ClinicalTrials.gov