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NCT Number: NCT07417644

Effect of Laser Acupuncture on Tension Headache in Post-Pubertal Females

This study will be carried out to evaluate the effect of laser acupuncture on tension headache in post-pubertal females.

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Key information

Age range

15 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Low energy laser acupuncture

Other

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 Technique

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Assessment of trigger point threshold

    Time frame: 6 weeks

    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.

  2. Assessment of headache severity

    Time frame: 6 weeks

    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.

  3. Cervical Flexion Range of Motion

    Time frame: 6 weeks

    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.

  4. Cervical Extension Range of Motion:

    Time frame: 6 weeks

    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.

  5. Right Cervical Lateral Flexion Range of Motion:

    Time frame: 6 weeks

    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.

  6. Left Cervical Lateral Flexion Range of Motion:

    Time frame: 6 weeks

    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.

  7. Right Cervical Rotation Range of Motion:

    Time frame: 6 weeks

    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.

  8. Left Cervical Rotation Range of Motion:

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mona Mohamed Nour El Din Morsi, M.Sc

CONTACT

[email protected]

+20 10 18447734

Soheir Mahmoud El-Kosery, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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