- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06733896
SCM Muscle Released in Patients with Cervicogenic Headache
February 10, 2025 updated by: Hanan Hosny M Battesha, Al-Zaytoonah University of Jordan
The Effectiveness of Sternocleidomastoid Muscle Pressure Points in Patients with Cervicogenic Headache
Sternocleidomastoid syndrome is often characterized by referred pain in other areas.
Like all muscles, the SCM can develop tight, and non-contracting bands called trigger points that can refer pain elsewhere.
For the SCM, the trigger point referral areas are the eye and forehead, the back of the head (occiput), front of the neck, cheek, and side of the head.
Trigger points can be treated by direct manual massage, dry needling, or platelet-poor plasma injection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cervicogenic headache is a specific type of headache that originates from the cervical spine and is typically chronic in nature.
Diagnostic criteria for CGH have been established by the International Headache Society (IHS) and are cited extensively in the literature.
Diagnosis of CGH through manual examination is a more recent practice.
To our knowledge, no systematic review of manual diagnosis of CGH has been performed.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Makka, Saudi Arabia
- Umm Al Qura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- History of CGH ≥ 3 months at Baseline 1, ≥5 days of CGH per month
- CGH intensity ≥3 (0-10 scale)
- Cervical spine dysfunction (cervical joint tenderness and/or restricted segmental motion)
- Clear temporal sequence linking the source of CGH to the neck: headache preceded by neck pain, stiffness, movement and/or awkward postures
Exclusion Criteria:
- Other headaches within one year of enrollment (e.g. migraine occurring on >1 day per month in the last year, medication overuse, daily, cluster, temporomandibular joint dysfunction related headaches, sinus, posttraumatic, tumor and glaucoma related, occipital neuralgia, metabolic/toxic/substance abuse related).
- Spinal manipulative therapy, massage or exercise therapy for neck pain or headaches in the previous 3 months. Any other types of care by a licensed provider in the previous month for headaches or neck pain
- Contraindications to study treatments (e.g., inflammatory arthropathies, cervical instability, severe osteoporosis, vertigo, dizziness)
- Daily prescription or nonprescription pain medication; corticosteroid use in previous month
- Cancer in the past five years
- ear problem
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
|
Manual Cervical Traction Technique and others
|
|
Experimental: study group
|
The midpoint of the sternocleidomastoid muscle with abundant nerve distribution and the onset and endpoint of the sternocleidomastoid muscle were used as acupoints, which can relieve localised muscle spasms and promote nerve nutrition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cervical neck pain
Time Frame: 4 weeks
|
visual analogue scale: This pain scale is most commonly used. A person rates their pain on a scale of 0 to 10 or 0 to 5. Zero means "no pain," and 5 or 10 means "the worst possible pain." These pain intensity levels may be assessed upon initial treatment, or periodically after treatment. |
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
biodex balance system
Time Frame: 4 weeks
|
assessment of posture stability, level eight was selected on the (the most stable level), then the dynamic limit of stability testing mode was selected and then the data of each patient were inserted into the device.
The patient was instructed to try to achieve a centered position on the platform by moving their feet, once the platform was programmed to move.
Visual feedback was provided on screen, with the cursor moving in relation to the feedback from the patients' feet.
Once the cursor had been centered, the platform was kept level beneath the patient's feet while the patient was standing in a comfortable upright position
|
4 weeks
|
|
neck stability index
Time Frame: 4 weeks
|
It is patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, each item scored with a possible 0-5 value with the larger number indicating a higher self-reported disability status.
The score on this questionnaire can range from 0-50.
In order to calculate a percentage, simply multiply the final value by two
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Actual)
February 10, 2025
Study Completion (Actual)
February 10, 2025
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 10, 2024
First Posted (Actual)
December 13, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 10, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cervicogenic Headache
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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