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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hanan hosny Battesha, associate professor
  • Phone Number: +962775661825
  • Email: h.hosny@zuj.edu.jo

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group
Other: neck exercises
Manual Cervical Traction Technique and others
Experimental: study group
Other: trigger point pressure
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Zaytoonah University of Jordan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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