NCT06940167

Brief Summary

Cervicogenic headache (CGH) is defined as a headache accompanied by neck pain, caused by a disorder in the cervical spine, bones, discs, or soft tissue elements. This study is designed as a prospective, case-control, hospital-based study. A total of 90 patients aged 18-65 years who have been suffering from CGH for at least three months and who present to the Physical Medicine and Rehabilitation Clinic of Meram State Hospital between January 2025 and January 2027 will be included in the study. Patients will be informed about the procedures, and informed consent will be obtained. The study will be conducted in accordance with the Declaration of Helsinki. A detailed medical history will be taken from all participants, and a comprehensive physical examination will be performed. Sociodemographic and clinical characteristics such as age, gender, height, weight, education level, employment status, and income level will be recorded. The 90 CGH patients will be divided into three groups.Group 1 (n=30) will receive myofascial release therapy + home exercise program for four weeks, three sessions per week, totaling 12 sessions. Group 2 (n=30) will receive Kinesio taping + home exercise program for four weeks, three sessions per week, totaling 12 sessions. Group 3 (n=30) will receive only a home exercise program for four weeks, three sessions per week, totaling 12 sessions. All evaluations will be conducted by the same researcher at three time points: before treatment (baseline), at the end of treatment (week 4), and one month after the completion of treatment (week 8).The aim of this prospective clinical study is to compare the effectiveness of Kinesio taping and myofascial release therapy in the treatment of cervicogenic headache.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

April 9, 2025

Last Update Submit

November 15, 2025

Conditions

Keywords

Cervicogenic headacheMyofascial ReleaseKinesio taping

Outcome Measures

Primary Outcomes (1)

  • Change in Cervicogenic Headache Severity Measured by Visual Analog Scale (VAS) at Baseline, 4 Weeks, and 8 Weeks

    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.

    Baseline, Week 4 (end of treatment), and Week 8 (1-month follow-up after treatment)

Secondary Outcomes (4)

  • Change in Headache Impact Test (HIT-6) Score at Baseline, 4 Weeks, and 8 Weeks

    Baseline, Week 4, and Week 8

  • Change in Headache Disability Index (HDI) Score at Baseline, 4 Weeks, and 8 Weeks

    Baseline, Week 4, and Week 8

  • Change in Quality of Life Measured by Short Form-12 (SF-12) at Baseline, 4 Weeks, and 8 Weeks

    Baseline, Week 4, and Week 8

  • Change in Headache Frequency (Number of Headache Days per Month) at Baseline, 4 Weeks, and 8 Weeks

    Baseline, Week 4, and Week 8

Study Arms (3)

Myofascial Release Group

EXPERIMENTAL

Group 1 (n=30) will receive myofascial release therapy + home exercise program for four weeks, three sessions per week, totaling 12 sessions.

Other: Myofascial Release GroupOther: Home Exercise Program (Control Group)

Kinesiology Taping Group

EXPERIMENTAL

Group 2 (n=30) will receive Kinesio taping + home exercise program for four weeks, three sessions per week, totaling 12 sessions

Other: Kinesiology Taping GroupOther: Home Exercise Program (Control Group)

Home Exercise Group

EXPERIMENTAL

Group 3 (n=30) will receive only a home exercise program for four weeks, three sessions per week, totaling 12 sessions

Other: Home Exercise Program (Control Group)

Interventions

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.

Myofascial Release Group

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.

Kinesiology Taping Group

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.

Home Exercise GroupKinesiology Taping GroupMyofascial Release Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meram State Hospital

Konya, Meram, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Only the outcomes assessor was blinded to group allocation to reduce measurement bias. Participants and care providers were aware of the intervention being applied.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 23, 2025

Study Start

February 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 31, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) for all primary and secondary outcome measures (e.g., VAS, HIT-6, NDI, SF-12) will be made available to qualified researchers for secondary analysis. Data will be shared upon reasonable request, beginning 6 months after publication, for a period of 3 years. Access will be granted to researchers with methodologically sound proposals by contacting the Principal Investigator via institutional email.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
January 2026 - January 2029
Access Criteria
Qualified researchers with methodologically sound proposals will be able to request access to de-identified individual participant data (IPD), the study protocol, and the statistical analysis plan. Access will be provided upon reasonable request by contacting the Principal Investigator via institutional email. A data sharing agreement may be required before access is granted.

Locations