Tension-Type HeadacheNCT06482736
Effect Of Extracorporeal Shockwave Therapy on Tension-Type Headache in Adolescent Females
A study testing Extracorporeal Shockwave Therapy in people with Tension-Type Headache, run by October 6 University at 1 site in Egypt.
Trial summary
Chronic headaches in adolescents can have consequences such as absence from school, inability to maintain social activities, and additional disorders such as anxiety, depression, problems sleeping, and reduced quality of life to investigates the efficacy shock wave diathermy on tension headaches in adolescent females Read more about this study
- Who is it for?
- Ages 15 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2023to 22 Jan 2024
- 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 15 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Suffering from chronic tension headache (headaches occur 15 or more days a month for at least three months).
- Their age will range from 15 to 18 years.
- Having a sedentary lifestyle (A weekly physical activity of < 600 MET-minutes/ week in the international physical activity questionnaire)
- Having regular menstruation (28 to 34 days).
Who cannot join
- Using oral contraceptives or
- any hormonal treatment in the previous six months.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic headaches in adolescents can have consequences such as absence from school, inability to maintain social activities, and additional disorders such as anxiety, depression, problems sleeping, and reduced quality of life to investigates the efficacy shock wave diathermy on tension headaches in adolescent females
Read the detailed description
The prevalence of headaches increases with age, with a prevalence of 82% during adolescence. Extracorporeal Shockwave Therapy could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia
- Conditions
- Tension-Type Headache
- Being tested
- Extracorporeal Shockwave Therapy
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyDevice
Extracorporeal Shockwave Therapy could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | receive exercise program for 20-30 min which include include cervical ROM to warm up,cool down, and stretching of cervical, upper thoracic spine (trapezius,levator scapula, sternocleidomastoid) and strengthening exercises (cervical isometric,concentric conctration of deep flexor muscles) each exercise consist of three sets of five to ten repetitions will be performed with 30-60S rest period between sets Receives: Device: Extracorporeal Shockwave Therapy |
| Study group | Experimental | receive Extracorporeal Shockwave Therapy and the same exercise program as group A, three sessions per week for 12 weeks (3 menstrual cycles). Receives: Device: Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
digital algometer
Measure pain intensity pre and post treatment which tested the pain points of the muscles: upper trapezius, levator scapula, sternocleidomastoid, splenius head and neck bilaterally.
Measured: The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
Electromyography (EMG) for neck muscles
Measure muscle activity pre and post treatmentupper trapezius, levator scapula, sternocleidomastoid, splenius head and neck bilaterally
Measured: The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
Headache impact test questionnaire
The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
Measured: The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start5 Jan 2023
- Primary completion8 Aug 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolous Ishak Shehata, October 6 University
- Investigators
- Kerolous IS kelini, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482736
- Sponsor's protocol ID
- P.T.REC/012/004547
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Extracorporeal Shockwave Therapy on Tension-Type Headache in Adolescent Females
- ClinicalTrials.gov ID
- NCT06482736
- Acronym / sponsor ID
- P.T.REC/012/004547
- Conditions
- Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 1 Jul 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.
Chronic headaches in adolescents can have consequences such as absence from school, inability to maintain social activities, and additional disorders such as anxiety, depression, problems sleeping, and reduced quality of life to investigates the efficacy shock wave diathermy on tension headaches in adolescent females
Detailed description
The prevalence of headaches increases with age, with a prevalence of 82% during adolescence. Extracorporeal Shockwave Therapy could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Device: Extracorporeal Shockwave Therapyreceive exercise program for 20-30 min which include include cervical ROM to warm up,cool down, and stretching of cervical, upper thoracic spine (trapezius,levator scapula, sternocleidomastoid) and strengthening exercises (cervical isometric,concentric conctration of deep flexor muscles) each exercise consist of three sets of five to ten repetitions will be performed with 30-60S rest period between sets |
| Study group | Experimental | Device: Extracorporeal Shockwave Therapyreceive Extracorporeal Shockwave Therapy and the same exercise program as group A, three sessions per week for 12 weeks (3 menstrual cycles). |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Suffering from chronic tension headache (headaches occur 15 or more days a month for at least three months).
- Their age will range from 15 to 18 years.
- Having a sedentary lifestyle (A weekly physical activity of < 600 MET-minutes/ week in the international physical activity questionnaire)
- Having regular menstruation (28 to 34 days).
Key exclusion criteria (2 listed)
- Using oral contraceptives or
- any hormonal treatment in the previous six months.
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 |
|---|---|---|
| Extracorporeal Shockwave TherapyExtracorporeal Shockwave Therapy could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia. | Device | Control group, Study group |
Primary outcome
digital algometer
Time frame: The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
Measure pain intensity pre and post treatment which tested the pain points of the muscles: upper trapezius, levator scapula, sternocleidomastoid, splenius head and neck bilaterally.
Electromyography (EMG) for neck muscles
Time frame: The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
Measure muscle activity pre and post treatmentupper trapezius, levator scapula, sternocleidomastoid, splenius head and neck bilaterally
Headache impact test questionnaire
Time frame: The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
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 1 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Tension-Type Headache
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
RecruitingPhase 4
Treatment of Tension-type Headache by Zhixuan Analgesic Tablets
Frequent Episodic Tension-Type Headache
Not yet recruitingObservational study
Prevalence of Primary Headache in Multiple Sclerosis Patients
Multiple Sclerosis, Primary Headache Disorders
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
Recruiting
High- vs Standard-Dose Intravenous Magnesium for Acute Headache
Acute Headache, Migraine
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.
Kerolous IS kelini study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy in people with Tension-Type 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 4 inclusion and 2 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 1 Jul 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?
digital algometer (time frame: The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.). The study lists 3 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 1 Jul 2024.