Tension HeadacheNCT07417644
Effect of Laser Acupuncture on Tension Headache in Post-Pubertal Females
A study testing Low energy laser acupuncture and Myofascial release technique in people with Tension Headache, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be carried out to evaluate the effect of laser acupuncture on tension headache in post-pubertal females. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women only
- Conditions the study is for
- Tension Headache
- What is being tested?
- Low energy laser acupuncture and Myofascial release technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Their age will be ranged from 15 to 18 years.
- Their body mass index (BMI) will be ranged from 20-25 Kg/m2.
- All participants will be diagnosed with tension type headache for which they haven't receive any treatment in the previous two weeks.
- Pain quality is typically pressing or tightening of mild to moderate intensity, bilateral in location and not worsening during routine physical activity.
- Absence of nausea and vomiting.
Who cannot join
- Patients with other causes of headache.
- Patients who have pulsating headaches, neurological deficits or metabolic disorders.
- Contraindications to treatment (other simultaneous treatment, localized skin infection, fear).
- Previous head trauma.
- Previous physical therapy treatment for tension type headache during the last 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Soheir Mahmoud El-Kosery, PhD contact
Egypt1 site
Secondary schools
Cairo
Mona Mohamed Nour El Din Morsi, M.Sc, +20 10 18447734, monanour2011@gmail.com
About this study
This study will be carried out to evaluate the effect of laser acupuncture on tension headache in post-pubertal females.
Read the detailed description
The post-pubertal period significantly associated in increasing an adolescent female's risk of primary headache. Menses is a trigger for headache for 38% to 45% of women with tension-type headache (TTH), implying some link between TTH and sex hormones. Post pubertal modifications in certain brain areas, specifically the hypothalamus, were thought to act as major modulators of this risk.
Low-level laser therapy (LLLT) is a novel, noninvasive, and cost-effective approach in the field of physiotherapy. Because of its unique properties, low-power laser irradiation can alter cellular metabolism (bio-stimulating effect), reduce pain (analgesic effect), improve the wound healing procedure (regenerative/reparative effect), reduce edema, and accelerate the inflammation process (anti-inflammatory effect). LLLT has been employed as a treatment modality for a variety of conditions in medicine and dentistry including musculoskeletal pain syndrome, soft tissue injuries and ulcerations, dentin hypersensitivity, and attenuating the complications of surgical procedures.
Needle acupuncture is a treatment modality based on traditional Chinese medicine, in which small needles made from stainless steel are inserted into special points of the body to improve health or reduce pain in other parts of the body. Despite its proven effects in curing numerous diseases, acupuncture is associated with some disadvantages that reduce its acceptability and popularity among patients, such as aggressive nature of needle insertion and difficult application in some parts of the body such as points around the perineum or genitals. Recently, laser acupuncture therapy (LAT) has been proposed as an alternative to conventional acupuncture therapy to eliminate the need for needle insertion. In this way, low-intensity laser light is employed for stimulating the traditional acupuncture points, and so the procedure is simple, non-aggressive, painless, and inherently safer than needle acupuncture therapy.
- Conditions
- Tension Headache
- Being tested
- Low energy laser acupuncture, Myofascial release technique
- 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.
Low energy laser acupunctureOther
The experimental group will receive low-energy laser acupuncture therapy. The laser will deliver 1.3 joules (approximately 13 joules per square centimeter) per point at 100 percent output in continuous mode, applied with vertical contact and slight pressure for 40 seconds per point. Four acupuncture points will be treated bilaterally according to published protocols: Gallbladder 14 and Gallbladder 20 as local head points, and Large Intestine 4 and Lung 7 as distal points on the hand and forearm. Both therapist and patient will wear protective goggles during treatment for safety.
Myofascial release techniqueOther
All participant in both groups will receive myofascial release technique for 6 weeks. Soft tissue and trigger point release techniques will be applied on the muscles/fascia reproducing the patient's symptoms (the occipitalis, suboccipitalis, splenius, sternocleidomastoid, and trapezius). Various myofascial techniques will employed such as effleurage, deep friction massage, ischemic compression and muscle energy techniques.
| Study group | Role | What they receive |
|---|---|---|
| Low energy laser acupuncture + Myofascial release technique | Experimental | It will consist of 30 post-pubertal females diagnosed with tension headache, who will receive low energy laser acupuncture treatment, a duration of 40 seconds, three times per week for 6 weeks in addition to myofascial release technique. Receives: Other: Low energy laser acupuncture; Other: Myofascial release technique |
| Myofascial release technique | Active comparator | It will consist of 30 post-pubertal females diagnosed with tension headache, who will receive the same myofascial release technique only. Receives: Other: Myofascial release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity
It will be assessed using Visual Analogue Scale (VAS), the scores range from 0 (no pain) to 10 (the worst possible pain).
Measured: 6 weeks
Secondary outcomes (8)
Assessment of trigger point threshold
It will be assessed using pressure pain algometer to detect and confirm the site and sensitivity of trigger points by determining the pressure pain threshold (PPT) using a pressure gauge probe.
Measured: 6 weeks
Assessment of headache severity
It will be will be assessed using the Headache Disability Index (HDI), a 25-item self-report questionnaire that measures the impact of tension-type headache on daily life. It comprises 12 functional items and 13 emotional items, yielding a total score from 0 to 100, with higher scores indicating greater disability. This tool allows evaluation of treatment effects on both functional performance and emotional well-being.
Measured: 6 weeks
Cervical Flexion Range of Motion
Cervical flexion will be assessed using a Cervical Range of Motion (CROM) device. Participants will be instructed to bend the head forward maximally while maintaining a seated upright posture. The angle achieved, measured in degrees, will be recorded to quantify sagittal plane flexion mobility of the cervical spine.
Measured: 6 weeks
Cervical Extension Range of Motion:
Cervical extension will be measured using the CROM device. Participants will be asked to extend the head backward to the maximum comfortable range. The degree of extension will be recorded to evaluate posterior sagittal plane cervical mobility.
Measured: 6 weeks
Right Cervical Lateral Flexion Range of Motion:
Right side bending of the cervical spine will be measured using the CROM device. Participants will tilt the head toward the right shoulder without trunk compensation. The achieved angle in degrees will be documented to assess right frontal plane mobility.
Measured: 6 weeks
Left Cervical Lateral Flexion Range of Motion:
Left side bending will be evaluated using the CROM device. Participants will tilt the head toward the left shoulder while maintaining neutral trunk alignment. The measured angle in degrees will represent left frontal plane cervical mobility.
Measured: 6 weeks
Right Cervical Rotation Range of Motion:
Right cervical rotation will be assessed using the CROM device. Participants will rotate the head to the right as far as comfortably possible. The angle measured in degrees will reflect right transverse plane mobility.
Measured: 6 weeks
Left Cervical Rotation Range of Motion:
Left cervical rotation will be measured using the CROM device. Participants will rotate the head to the left to the maximum comfortable limit. The recorded angle in degrees will represent left transverse plane cervical mobility.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start20 Feb 2026 (estimated)
- Primary completion20 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension HeadacheStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Nour El Din Morsi, Cairo University
- Investigators
- Soheir Mahmoud El-Kosery, PhD, Study chair, Professor, Cairo UniversityMohamed Fawzy Abu-Elenin, PhD, Study director, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417644
- Sponsor's protocol ID
- P.T.REC/012/005135
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Tension Headache in Post-Pubertal Females
- ClinicalTrials.gov ID
- NCT07417644
- Acronym / sponsor ID
- P.T.REC/012/005135
- Conditions
- Tension Headache
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 18 Feb 2026 (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.
This study will be carried out to evaluate the effect of laser acupuncture on tension headache in post-pubertal females.
Detailed description
The post-pubertal period significantly associated in increasing an adolescent female's risk of primary headache. Menses is a trigger for headache for 38% to 45% of women with tension-type headache (TTH), implying some link between TTH and sex hormones. Post pubertal modifications in certain brain areas, specifically the hypothalamus, were thought to act as major modulators of this risk.
Low-level laser therapy (LLLT) is a novel, noninvasive, and cost-effective approach in the field of physiotherapy. Because of its unique properties, low-power laser irradiation can alter cellular metabolism (bio-stimulating effect), reduce pain (analgesic effect), improve the wound healing procedure (regenerative/reparative effect), reduce edema, and accelerate the inflammation process (anti-inflammatory effect). LLLT has been employed as a treatment modality for a variety of conditions in medicine and dentistry including musculoskeletal pain syndrome, soft tissue injuries and ulcerations, dentin hypersensitivity, and attenuating the complications of surgical procedures.
Needle acupuncture is a treatment modality based on traditional Chinese medicine, in which small needles made from stainless steel are inserted into special points of the body to improve health or reduce pain in other parts of the body. Despite its proven effects in curing numerous diseases, acupuncture is associated with some disadvantages that reduce its acceptability and popularity among patients, such as aggressive nature of needle insertion and difficult application in some parts of the body such as points around the perineum or genitals. Recently, laser acupuncture therapy (LAT) has been proposed as an alternative to conventional acupuncture therapy to eliminate the need for needle insertion. In this way, low-intensity laser light is employed for stimulating the traditional acupuncture points, and so the procedure is simple, non-aggressive, painless, and inherently safer than needle acupuncture therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low energy laser acupuncture + Myofascial release technique | Experimental | Other: Low energy laser acupuncture, Other: Myofascial release techniqueIt will consist of 30 post-pubertal females diagnosed with tension headache, who will receive low energy laser acupuncture treatment, a duration of 40 seconds, three times per week for 6 weeks in addition to myofascial release technique. |
| Myofascial release technique | Active comparator | Other: Myofascial release techniqueIt will consist of 30 post-pubertal females diagnosed with tension headache, who will receive the same myofascial release technique only. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Their age will be ranged from 15 to 18 years.
- Their body mass index (BMI) will be ranged from 20-25 Kg/m2.
- All participants will be diagnosed with tension type headache for which they haven't receive any treatment in the previous two weeks.
- Pain quality is typically pressing or tightening of mild to moderate intensity, bilateral in location and not worsening during routine physical activity.
- Absence of nausea and vomiting.
Key exclusion criteria (5 listed)
- Patients with other causes of headache.
- Patients who have pulsating headaches, neurological deficits or metabolic disorders.
- Contraindications to treatment (other simultaneous treatment, localized skin infection, fear).
- Previous head trauma.
- Previous physical therapy treatment for tension type headache during the last 6 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 |
|---|---|---|
| Low energy laser acupunctureThe experimental group will receive low-energy laser acupuncture therapy. The laser will deliver 1.3 joules (approximately 13 joules per square centimeter) per point at 100 percent output in continuous mode, applied with vertical contact and slight pressure for 40 seconds per point. Four acupuncture points will be treated bilaterally according to published protocols: Gallbladder 14 and Gallbladder 20 as local head points, and Large Intestine 4 and Lung 7 as distal points on the hand and forearm. Both therapist and patient will wear protective goggles during treatment for safety. | Other | Low energy laser acupuncture + Myofascial release technique |
| Myofascial release techniqueAll participant in both groups will receive myofascial release technique for 6 weeks. Soft tissue and trigger point release techniques will be applied on the muscles/fascia reproducing the patient's symptoms (the occipitalis, suboccipitalis, splenius, sternocleidomastoid, and trapezius). Various myofascial techniques will employed such as effleurage, deep friction massage, ischemic compression and muscle energy techniques. | Other | Low energy laser acupuncture + Myofascial release technique, Myofascial release technique |
Primary outcome
Assessment of pain intensity
Time frame: 6 weeks
It will be assessed using Visual Analogue Scale (VAS), the scores range from 0 (no pain) to 10 (the worst possible pain).
8 secondary outcomes
Assessment of trigger point threshold
Time frame: 6 weeks
Assessment of headache severity
Time frame: 6 weeks
Cervical Flexion Range of Motion
Time frame: 6 weeks
Cervical Extension Range of Motion:
Time frame: 6 weeks
Right Cervical Lateral Flexion Range of Motion:
Time frame: 6 weeks
Left Cervical Lateral Flexion Range of Motion:
Time frame: 6 weeks
Right Cervical Rotation Range of Motion:
Time frame: 6 weeks
Left Cervical Rotation Range of Motion:
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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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.
Soheir Mahmoud El-Kosery, PhD contact
Soheir Mahmoud El-Kosery, PhD study chair
Professor, Cairo University
Mohamed Fawzy Abu-Elenin, PhD study director
Consultant
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 energy laser acupuncture and Myofascial release technique in people with Tension Headache, run by Cairo 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Mohamed Nour El Din Morsi, M.Sc (+20 10 18447734, monanour2011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain intensity (time frame: 6 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 18 Feb 2026.