Cervicogenic HeadacheNCT05939583
Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache.
A study testing Shock Wave Therapy and US, TENS, IR and exercises. in people with Cervicogenic Headache, run by October 6 University at 1 site in Egypt.
Trial summary
Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Shock Wave Therapy and US, TENS, IR and exercises.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 1 Feb 2023
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fifty patients from both genders.
- Age ranging from 20 to 40 years.
- Referred by an orthopedist with a diagnosis of Mechanical neck dysfunction (MND) to physical therapy at the outpatient clinic of the Faculty of Physical Therapy, MTI University.
Who cannot join
- All other disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial
Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks.
Read the detailed description
Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks.
- Conditions
- Cervicogenic Headache
- Being tested
- Shock Wave Therapy, US, TENS, IR and exercises.
- Keywords
- Shock wave therapy, Trapezius trigger points, Cervicogenic headache
- 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.
Shock Wave TherapyOther
Also called US, TENS, IR and exercises.
Receiving Shock wave therapy + US, TENS, IR and exercises.
US, TENS, IR and exercises.Other
Receiving US, TENS, IR and exercises only.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The treatment group will receive US, TENS, IR and exercises in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks Receives: Other: Shock Wave Therapy; Other: US, TENS, IR and exercises. |
| Control Group | Experimental | Control group will receive US, TENS, IR and exercises. Patients will receive 3 sessions per week for 4 weeks Receives: Other: US, TENS, IR and exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Assess degree of pain from 1 (No Pain) to 10 (Severe Pain)
Measured: 4 weeks
Neck disability index
Assess degree of neck disability.
Measured: 4 weeks
Kinesiological EMG
Analysis of root mean square for upper trapezius muscle functions.
Measured: 4 weeks
Kinesiological EMG
Analysis of median frequency for upper trapezius muscle functions.
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 posted11 Jul 2023
- Study start1 Feb 2022
- Primary completion1 Sep 2022
- Study completion1 Feb 2023
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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdy Alshimy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939583
- Sponsor's protocol ID
- REC/2111/MTI.PT/2303123
- Status last verified
- Mar 2024
- First submitted
- 3 Jul 2023
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05939583
- Acronym / sponsor ID
- REC/2111/MTI.PT/2303123
- Conditions
- Cervicogenic Headache
- Keywords
- Shock wave therapy, Trapezius trigger points, Cervicogenic headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 11 Jul 2023 (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.
Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks.
Detailed description
Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Shock Wave Therapy, Other: US, TENS, IR and exercises.The treatment group will receive US, TENS, IR and exercises in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks |
| Control Group | Experimental | Other: US, TENS, IR and exercises.Control group will receive US, TENS, IR and exercises. Patients will receive 3 sessions per week for 4 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fifty patients from both genders.
- Age ranging from 20 to 40 years.
- Referred by an orthopedist with a diagnosis of Mechanical neck dysfunction (MND) to physical therapy at the outpatient clinic of the Faculty of Physical Therapy, MTI University.
Key exclusion criteria (1 listed)
- All other disorders.
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 |
|---|---|---|
| Shock Wave TherapyAlso: US, TENS, IR and exercises.Receiving Shock wave therapy + US, TENS, IR and exercises. | Other | Treatment Group |
| US, TENS, IR and exercises.Receiving US, TENS, IR and exercises only. | Other | Control Group, Treatment Group |
Primary outcome
Visual analogue scale
Time frame: 4 weeks
Assess degree of pain from 1 (No Pain) to 10 (Severe Pain)
Neck disability index
Time frame: 4 weeks
Assess degree of neck disability.
Kinesiological EMG
Time frame: 4 weeks
Analysis of root mean square for upper trapezius muscle functions.
Kinesiological EMG
Time frame: 4 weeks
Analysis of median frequency for upper trapezius muscle functions.
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 15 Mar 2024.
- 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 Shock Wave Therapy and US, TENS, IR and exercises. in people with Cervicogenic Headache, run by October 6 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 3 inclusion and 1 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 15 Mar 2024. 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. 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?
Visual analogue scale (time frame: 4 weeks). The study lists 4 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 15 Mar 2024.