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CompletedNCT05883319Updated Mar 27, 2024

The Effect Of Cervical Mobilization And Clinical Pilates in Cervicogenic Headache

An interventional study of manuel therapy and exercises in Headache, Cervicogenic, Exercise and Therapeutics, sponsored by Meltem Uzun. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by Meltem Uzun · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Cervicogenic headache (CH) arises from cervical region problems. Various physiotherapy methods such as manual therapy approaches and exercise training are used in the treatment of CH. The aim of our study is to investigate cervical mobilization and clinical Pilates exercises on pain, muscle stiffness, head and neck blood flow in CH. Including individuals diagnosed with CH in the study. Those to be included in the study will be divided into 3 groups by a simple method. Demographic information of the individuals, age, height, weight, Body Mass Index (BMI), gender, educational status, occupation, marital status, smoking, alcohol use will be recorded. In evaluations about pain before treatment; pain intensity, pain frequency, duration and characteristics will be evaluated with Visual Analog Scale (VAS). In addition, analgesic use (frequency, amount) in headache situations will be recorded. Migraine Disability Assessment Scale (MIDAS) will be used to determine the effect of headache on quality of life. Disability Index will be used in the assessment of functional desire, and Postur Screen mobile application will be used in the assessment of posture. Range of motion(ROM) of all neck joint movements will be evaluated by CROM goniometer, deep neck flexor muscle strength by Pressure Biofeedback Unit (PBU), sternocleidomastoid(SKM), suboccipital and upper trapezius muscle stiffness myotonometer, and head-neck artery flow volume will be evaluated by Doppler ultrasound. Cervical mobilization methods will be applied to the 1st group, clinical pilates applications to the 2nd group, clinical pilates with cervical mobilization will be applied to the 3rd group for 3 days / week for 6 weeks. All evaluations were completed again after the 3rd week and after the treatment. After the obtained results are obtained, the literature will be discussed.

Read the detailed description

The scope of the study, including patients over 18 years of age who applied to the Neurology outpatient clinic of Sani Konukoğlu Application and Research Hospital and presented with cervicogenic headache by a specialist. The sometimes headache frequency variable in the reference result was 5% Power analysis calculated 9 patients per group. It was decided to recruit 15 patients for the group. Inclusion criteria: CH was diagnosed, aged 18-65, had not received medical (except analgesic) treatment or physiotherapy for CH in the previous few months. Exclusion criteria: Individuals who have undergone CH surgery, history of serious heart or surgery, history of ongoing malignancy, diagnosed with epilepsy. Individuals for whom the Voluntary Consent form will be obtained will be randomly divided into groups using the minimalization method given age, gender and duration of illness.Patients will be asked not to use analgesics as much as possible during the treatment period. In the case of analgesic use, the amount and frequency will be recorded. The change in the frequency of analgesic use will also be used to evaluate the effectiveness of the applications.

02

Conditions studied

  • Headache, Cervicogenic
  • Exercise
  • Therapeutics

Keywords

  • Cervicogenic Headache,
  • Pilates based exercises
  • Cervical mobilization
  • Blood flow
  • posture
  • muscle stifness
03

In context

Post-Traumatic Headache

188 studies on the registry are indexed under Post-Traumatic Headache; 50 are open to participants now.

This study's enrollment of 45 is close to the median of 44 across 166 interventional studies indexed under Post-Traumatic Headache.

Browse Post-Traumatic Headache studies →

Lead sponsor

Meltem Uzun is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

Inclusion criteria

  • Diagnosed with Cervicogenic Headache
  • aged 18-65
  • did not receive medical (except analgesic) treatment or physiotherapy for bit Cervicogenic Headache in the previous few months

Exclusion criteria

Exclusion Criteria:

  • Individuals who have undergone Cervicogenic Headache surgery
  • have had a serious cardiac history or surgery
  • a history of ongoing or previous malignancy
  • a diagnosis of epilepsy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    cervical mobilization

    Cervical mobilization methods will be applied to 1st group for 3 days / week for 6 weeks.

    Other: manuel therapy

  • Active comparator
    clinical pilates exercises

    clinical pilates exercises will be applied to 2nd group,for 3 days / week for 6 weeks.

    Other: exercises

  • Active comparator
    cervical mobilization and clinical pilates exercises

    cervical mobilization and clinical pilates exercises will be applied to 3rd group,for 3 days / week for 6 weeks.

    Other: manuel therapy · Other: exercises

Interventions

  • Othermanuel therapy

    approaches will be applied for 3 days / week for 6 weeks.

    Also known as: cervical mobilization

  • Otherexercises

    approaches will be applied for 3 days / week for 6 weeks.

    Also known as: clinical pilates exercises

06

What researchers measure

Primary outcomes

  1. Change of headache

    headache intensity by Visual Analogue Scale , headache frequency and analgesic intake

    Time frame: 6 week

  2. Change of muscle stiffness degree

    SKM,suboccipital and upper trapezoidal muscle stiffness with Myoton Pro

    Time frame: 6 week

  3. Change of blood flow degree

    head-neck artery flow Doppler Ultrasound (US)

    Time frame: 6 week

  4. change of posture

    The PostureScreen Mobile® application

    Time frame: 6 week

Secondary outcomes

  1. neck range of motion

    range of motion by Cervical Range of Motion device

    Time frame: 6 week

  2. deep neck flexor muscle endurance

    muscle endurance by Pressure Biofeedback Unit

    Time frame: 6 week

  3. headache life quality

    Migraine Disability Assessment Scale for headache on quality of life.

    Time frame: 6 week

  4. neck functional status

    Neck Disability Index for functional status

    Time frame: 6 week

07

Study locations

1 site
  • SANKO University
    Gaziantep, Please Select 27060, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05883319
Lead sponsor
Meltem Uzun
Responsible party
Meltem Uzun (Director, Sanko University) — Sponsor-investigator
First posted
May 31, 2023
Start date
Apr 1, 2022
Primary completion
Apr 15, 2023
Completion
Jan 3, 2024
Last update
Mar 27, 2024

Study contacts

Meltem Uzun, PhD(c)
study director · Sanko University

Oversight

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

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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