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Not yet recruiting NCT07417644

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

No phase Interventional Tension Headache

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low energy laser acupuncture, Myofascial release technique.
Who it may be relevant to
Registry conditions: Tension Headache. Basic parameters: 15 years — 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Assessment of pain intensity [Time frame: 6 weeks]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Secondary schools — Cairo

Identifiers

NCT: NCT07417644 · P.T.REC/012/005135

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗