Cervicogenic HeadacheNCT06879418
Dose Related Effects of Radial Extracorporeal Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache.
A study testing Low dose shock wave therapy plus strengthening and stretching exercise for upper trapezius and Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapezius in people with Cervicogenic Headache, run by MTI University at 1 site in Egypt.
Trial summary
A randomized double blinded controlled trial will be conducted to determine and compare the effects of low and medium dose radial extracorporeal shock wave therapy on upper trapezius trigger points in patients with cervicogenic headache. Data will be collected at base line and at the end of the treatment program. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Low dose shock wave therapy plus strengthening and stretching exercise for upper trapezius and Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapezius
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 15 Sep 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptoms of mechanical neck pain lasting for more than three months
- Skeletal muscle with a palpable taut band
- Hypersensitive point inside the taut band with the ability to reproduce referred pain when the sensitive spot is palpated,
- Joint soreness in at least one of the upper cervical spine's joints (c1-c3)
- Unilateral discomfort that originates in the neck and radiates to the frontotemporal area
- Pain that is made worse by moving the neck
- Headaches that occur at least once a week for a duration longer than three months.
Who cannot join
- Other primary headaches (i.e., migraine, tension-type headache)
- Bilateral headaches,
- Other defined cervical problem such as fracture, dislocation, skin disease, illness that is inflammatory, neural illness, vertebrobasilar insufficiency, a birth defect, tumor, or infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Related Effects of Radial Extracorporeal Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache: A Randomized Controlled Trial
A randomized double blinded controlled trial will be conducted to determine and compare the effects of low and medium dose radial extracorporeal shock wave therapy on upper trapezius trigger points in patients with cervicogenic headache. Data will be collected at base line and at the end of the treatment program. Participants will be assigned randomly into three groups Group (A) will receive 2000 shock waves at frequency 10 MHz and 0.045 mj/mm2 flux density plus strengthening and stretching exercise for upper trapezius muscle.
Group (B) will receive 2000 shock waves at frequency 10 MHz and 0.18 mj/mm2 energy flux density plus strengthening and stretching exercise for upper trapezius muscle.
Group (C) will receive sham shock wave therapy plus strengthening and stretching exercise for upper trapezius muscle.
- Conditions
- Cervicogenic Headache
- Being tested
- Low dose shock wave therapy plus strengthening and stretching exercise for upper trapezius, Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapezius, sham shock wave therapy plus strengthening and stretching exercise for upper trapezius
- Keywords
- shock wave therapy
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose shock wave therapy plus strengthening and stretching exercise for upper trapeziusOther
Patients will receive 2000 shocks, 1 bar (energy flux density 0.045 mj/mm2) at frequency 10 MHz on upper trapezius trigger points plus strengthening and stretching exercises for upper trapezius.
Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapeziusOther
patients will receive 2000 shock with 4 bars (Energy flux density 0.18 mj/mm2) at frequency 10 MHz on upper trapezius trigger points plus strengthening and stretching for upper trapezius
sham shock wave therapy plus strengthening and stretching exercise for upper trapeziusOther
patients will receive 2000 shock with energy flus density 0.00 on upper trapezius trigger points plus strengthening and stretching exercise for upper trapezius.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Low dose shock wave therapy plus strengthening and stretching exercise. Receives: Other: Low dose shock wave therapy plus strengthening and stretching exercise for upper trapezius |
| Group B | Experimental | Medium dose shock wave therapy on upper trapezius trigger points plus strengthening and stretching exercise for upper trapezius Receives: Other: Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapezius |
| Group C | Sham comparator | Sham shock wave therapy plus strengthening and stretching exercises Receives: Other: sham shock wave therapy plus strengthening and stretching exercise for upper trapezius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Henry Ford Hospital Headache disability inventory (HDI)
Measured: before the first session and after the last session (Four weeks)
Upper trapezius electromyographic activity
Measured: before the first session and after the last session (Four weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Mar 2025
- Primary completion30 Aug 2025
- Study completion15 Sep 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Fayek Hammam, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879418
- Sponsor's protocol ID
- P.T.REC/012/005500
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Related Effects of Radial Extracorporeal Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06879418
- Acronym / sponsor ID
- P.T.REC/012/005500
- Conditions
- Cervicogenic Headache
- Keywords
- shock wave therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 17 Mar 2025 (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.
A randomized double blinded controlled trial will be conducted to determine and compare the effects of low and medium dose radial extracorporeal shock wave therapy on upper trapezius trigger points in patients with cervicogenic headache. Data will be collected at base line and at the end of the treatment program. Participants will be assigned randomly into three groups Group (A) will receive 2000 shock waves at frequency 10 MHz and 0.045 mj/mm2 flux density plus strengthening and stretching exercise for upper trapezius muscle.
Group (B) will receive 2000 shock waves at frequency 10 MHz and 0.18 mj/mm2 energy flux density plus strengthening and stretching exercise for upper trapezius muscle.
Group (C) will receive sham shock wave therapy plus strengthening and stretching exercise for upper trapezius muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Low dose shock wave therapy plus strengthening and stretching exercise for upper trapeziusLow dose shock wave therapy plus strengthening and stretching exercise. |
| Group B | Experimental | Other: Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapeziusMedium dose shock wave therapy on upper trapezius trigger points plus strengthening and stretching exercise for upper trapezius |
| Group C | Sham comparator | Other: sham shock wave therapy plus strengthening and stretching exercise for upper trapeziusSham shock wave therapy plus strengthening and stretching exercises |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Symptoms of mechanical neck pain lasting for more than three months
- Skeletal muscle with a palpable taut band
- Hypersensitive point inside the taut band with the ability to reproduce referred pain when the sensitive spot is palpated,
- Joint soreness in at least one of the upper cervical spine's joints (c1-c3)
- Unilateral discomfort that originates in the neck and radiates to the frontotemporal area
Key exclusion criteria (3 listed)
- Other primary headaches (i.e., migraine, tension-type headache)
- Bilateral headaches,
- Other defined cervical problem such as fracture, dislocation, skin disease, illness that is inflammatory, neural illness, vertebrobasilar insufficiency, a birth defect, tumor, or infection.
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 |
|---|---|---|
| Low dose shock wave therapy plus strengthening and stretching exercise for upper trapeziusPatients will receive 2000 shocks, 1 bar (energy flux density 0.045 mj/mm2) at frequency 10 MHz on upper trapezius trigger points plus strengthening and stretching exercises for upper trapezius. | Other | Group A |
| Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapeziuspatients will receive 2000 shock with 4 bars (Energy flux density 0.18 mj/mm2) at frequency 10 MHz on upper trapezius trigger points plus strengthening and stretching for upper trapezius | Other | Group B |
| sham shock wave therapy plus strengthening and stretching exercise for upper trapeziuspatients will receive 2000 shock with energy flus density 0.00 on upper trapezius trigger points plus strengthening and stretching exercise for upper trapezius. | Other | Group C |
Primary outcome
Henry Ford Hospital Headache disability inventory (HDI)
Time frame: before the first session and after the last session (Four weeks)
Upper trapezius electromyographic activity
Time frame: before the first session and after the last session (Four 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 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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 Low dose shock wave therapy plus strengthening and stretching exercise for upper trapezius and Medium dose shock wave therapy plus strengthening and stretching exercise for upper trapezius in people with Cervicogenic Headache, run by MTI University at 1 site in Egypt.
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 7 inclusion and 3 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 18 Nov 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Henry Ford Hospital Headache disability inventory (HDI) (time frame: before the first session and after the last session (Four weeks)). The study lists 2 primary outcomes in all. 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 18 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.