NCT07417644

Brief Summary

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Feb 2026May 2026

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 11, 2026

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Assessment of trigger point threshold

    6 weeks

  • Assessment of headache severity

    6 weeks

  • Cervical Flexion Range of Motion

    6 weeks

  • Cervical Extension Range of Motion:

    6 weeks

  • Right Cervical Lateral Flexion Range of Motion:

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

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.

Other: Low energy laser acupunctureOther: 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.

Other: Myofascial release technique

Interventions

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.

Low energy laser acupuncture + 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.

Low energy laser acupuncture + Myofascial release techniqueMyofascial release technique

Eligibility Criteria

Age15 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Secondary schools

Cairo, Egypt

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Soheir Mahmoud El-Kosery, PhD

    Professor, Cairo University

    STUDY CHAIR
  • Mohamed Fawzy Abu-Elenin, PhD

    Consultant

    STUDY DIRECTOR

Central Study Contacts

Mona Mohamed Nour El Din Morsi, M.Sc

CONTACT

Soheir Mahmoud El-Kosery, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations