Cervicogenic HeadacheNCT06733896
SCM Muscle Released in Patients with Cervicogenic Headache
A study testing trigger point pressure and neck exercises in people with Cervicogenic Headache, run by Al-Zaytoonah University of Jordan at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- trigger point pressure and neck exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2025to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- trigger point pressure, neck exercises
- Keywords
- trigger points, sternocleidomastoid, headaches
- Medical subject headings
- Post-Traumatic Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trigger point pressureOther
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.
neck exercisesOther
Manual Cervical Traction Technique and others
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Other: trigger point pressure |
| control group | Active comparator | Not described Receives: Other: neck exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical neck pain
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.
Measured: 4 weeks
Secondary outcomes (2)
biodex balance system
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
Measured: 4 weeks
neck stability index
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Jan 2025
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Hosny M Battesha, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733896
- Sponsor's protocol ID
- Cervicogenic Headache
- Status last verified
- Feb 2025
- First submitted
- 5 Dec 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Sternocleidomastoid Muscle Pressure Points in Patients with Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT06733896
- Acronym / sponsor ID
- Cervicogenic Headache
- Conditions
- Cervicogenic Headache
- Keywords
- trigger points, sternocleidomastoid, headaches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: trigger point pressure |
| control group | Active comparator | Other: neck exercises |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trigger point pressureThe 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. | Other | study group |
| neck exercisesManual Cervical Traction Technique and others | Other | control group |
Primary outcome
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.
2 secondary outcomes
biodex balance system
Time frame: 4 weeks
neck stability index
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trigger point pressure and neck exercises in people with Cervicogenic Headache, run by Al-Zaytoonah University of Jordan at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cervical neck pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.