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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tension Headache
• Intervention / Treatment: Other: Low energy laser acupuncture; Other: Myofascial release technique

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mona Mohamed Nour El Din Morsi, M.Sc; Phone Number: +20 10 18447734; Email: monanour2011@gmail.com
• Study Contact Backup: Name: Soheir Mahmoud El-Kosery, PhD

Study Locations

• Egypt
  • Cairo, Egypt
    • Secondary schools
    • Contact: Mona Mohamed Nour El Din Morsi, M.Sc; Phone Number: +20 10 18447734; Email: monanour2011@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low energy laser acupuncture + Myofascial release technique; 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.	Other: Low energy laser acupuncture; 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.; Other: Myofascial release technique; 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.
Active Comparator: Myofascial release technique; It will consist of 30 post-pubertal females diagnosed with tension headache, who will receive the same myofascial release technique only.	Other: Myofascial release technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	6 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Soheir Mahmoud El-Kosery, PhD, Professor, Cairo university; Study Director: Mohamed Fawzy Abu-Elenin, PhD, Consultant

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Tension-Type Headache; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage; Myofascial Release Therapy
• Other Study ID Numbers: P.T.REC/012/005135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No