- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06940167
Comparison of Kinesio Taping and Myofascial Release in Cervicogenic Headache
Comparison of the Effectiveness of Kinesio Taping and Myofascial Release in Patients With Cervicogenic Headache
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Meram
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Konya, Meram, Turkey (Türkiye), 42090
- Meram State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Individuals aged 18-65 years Neck or headache persisting for at least 3 months
Meeting the diagnostic criteria for cervicogenic headache, including:
- Unilateral pain
- Reduced cervical range of motion
- Ipsilateral shoulder discomfort
- Ipsilateral arm discomfort
- Pain exacerbated by different neck movements and tenderness on palpation
Exclusion Criteria:
Migraine Cluster headache Cervical radiculopathy Entrapment neuropathy Myelopathy Rheumatoid arthritis Undergoing cervical spinal surgery Pregnancy Receiving physical therapy within the last 6 months History of major psychiatric disorders History of uncontrolled systemic diseases (cardiovascular, pulmonary, hepatic, renal, hematological, etc.) History of uncontrolled endocrine diseases (e.g., Diabetes Mellitus, hyperthyroidism, etc.)
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Myofascial Release Group
Group 1 (n=30) will receive myofascial release therapy + home exercise program for four weeks, three sessions per week, totaling 12 sessions.
|
myofascial release therapy combined with a home exercise program: Myofascial release techniques will be applied manually to the cervical and upper trapezius regions by a trained physiotherapist.
The intervention will be administered three times per week for four weeks, totaling 12 sessions.
In addition, participants will follow a standardized home exercise program designed to improve cervical mobility and reduce muscle tension.
Home exercise program: The exercise program includes cervical mobility exercises, stretching, and strengthening exercises aimed at improving posture and reducing muscle tension.
The intervention will be performed three times per week for four weeks, totaling 12 sessions.
|
|
Experimental: Kinesiology Taping Group
Group 2 (n=30) will receive Kinesio taping + home exercise program for four weeks, three sessions per week, totaling 12 sessions
|
Home exercise program: The exercise program includes cervical mobility exercises, stretching, and strengthening exercises aimed at improving posture and reducing muscle tension.
The intervention will be performed three times per week for four weeks, totaling 12 sessions.
kinesiology taping combined with a home exercise program : Kinesiology tape will be applied to the cervical region following a standardized taping protocol.
The taping will be performed by a trained physiotherapist three times per week for four weeks, totaling 12 sessions.
The tape will remain on the skin for 3-5 days per application.
|
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Experimental: Home Exercise Group
Group 3 (n=30) will receive only a home exercise program for four weeks, three sessions per week, totaling 12 sessions
|
Home exercise program: The exercise program includes cervical mobility exercises, stretching, and strengthening exercises aimed at improving posture and reducing muscle tension.
The intervention will be performed three times per week for four weeks, totaling 12 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cervicogenic Headache Severity Measured by Visual Analog Scale (VAS) at Baseline, 4 Weeks, and 8 Weeks
Time Frame: Baseline, Week 4 (end of treatment), and Week 8 (1-month follow-up after treatment)
|
Headache severity will be assessed using a 10 cm horizontal Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst possible pain."
Participants will mark the level of their current headache severity on the scale.
Changes will be calculated from baseline to week 4 and week 8.
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Baseline, Week 4 (end of treatment), and Week 8 (1-month follow-up after treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Headache Impact Test (HIT-6) Score at Baseline, 4 Weeks, and 8 Weeks
Time Frame: Baseline, Week 4, and Week 8
|
The HIT-6 is a six-item questionnaire evaluating the impact of headache on daily activities, scored from 36 to 78.
Higher scores indicate greater impact.
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Baseline, Week 4, and Week 8
|
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Change in Headache Disability Index (HDI) Score at Baseline, 4 Weeks, and 8 Weeks
Time Frame: Baseline, Week 4, and Week 8
|
The HDI is a 25-item questionnaire assessing the emotional and functional impact of headaches.
The total score is used to evaluate disability level.
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Baseline, Week 4, and Week 8
|
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Change in Quality of Life Measured by Short Form-12 (SF-12) at Baseline, 4 Weeks, and 8 Weeks
Time Frame: Baseline, Week 4, and Week 8
|
SF-12 evaluates general health and quality of life across physical and mental domains.
Scores are calculated per standard algorithm.
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Baseline, Week 4, and Week 8
|
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Change in Headache Frequency (Number of Headache Days per Month) at Baseline, 4 Weeks, and 8 Weeks
Time Frame: Baseline, Week 4, and Week 8
|
Headache frequency will be recorded using a headache diary.
The number of days with headache in the past 4 weeks will be used for assessment.
|
Baseline, Week 4, and Week 8
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/5545
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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