Therapeutic Efficacy of Different Wavelengths of Low-Level Laser Therapy in the Treatment of Cervicogenic Headache

Обзор

This study tests if low-level laser therapy (LLLT) with different light wavelengths can help people with cervicogenic headache, a type of headache caused by neck problems. Adults aged 18-65 with this headache for at least 3 months will try one of three LLLT treatments (675nm, 820nm, or a mix of wavelengths) along with regular physical therapy like stretching and exercises. The study will check pain levels, how often headaches happen, neck movement, disability, and quality of life over 6 weeks, with follow-ups at 3 and 6 months. the investigators want to find the best LLLT option to reduce headache symptoms safely.

Подробное описание

This single-center, single-blinded randomized clinical trial investigates the therapeutic efficacy of low-level laser therapy (LLLT) at different wavelengths-675nm (30mW), 820nm (200mW), and a 46-cluster LED probe (combining 660nm, 950nm, 870nm, 880nm, 940nm, 820nm)-in treating cervicogenic headache (CGH), a secondary headache originating from cervical spine dysfunction. Conducted at the Department of Physiotherapy, Sir Ganga Ram Hospital, Lahore, the study spans 18 months post-BASR approval, with a 6-week intervention period and 6-month follow-up. Participants are randomized into three parallel groups, each receiving LLLT (using the Omega XP Model) plus routine physical therapy (stretching, exercise, hot pack, TENS) three times weekly for 30 minutes over 18 sessions. The trial aims to compare the effectiveness of these modalities in reducing pain (VAS), headache frequency (diary), cervical range of motion (goniometry), neck disability (NDI), quality of life (SF-36), and forward head posture (camera). Ethical approval was granted by The University of Lahore's Research Ethical Committee (Ref: REC-UOL-/520/08/24, dated 05-09-2024), ensuring participant consent and confidentiality. The study addresses a research gap in wavelength-specific LLLT efficacy for CGH, potentially guiding future clinical practice.

Вмешательства

• Устройство Low-Level Laser Therapy (LLLT)
  Low-level laser therapy using the Omega XP Model with wavelengths of 675nm (30mW), 820nm (200mW), or 46-cluster LED probe (mixed wavelengths: 660nm, 950nm, 870nm, 880nm, 940nm, 820nm), applied three times weekly for 30 minutes over 6 weeks to target cervical lymphatic chain, musculature, and trigger points for pain relief in cervicogenic headache.
• Другое Routine Physical Therapy (RPT)
  Warm-up: Active cervical ROM (5-10 reps, pain-free range). Stretching: Upper trapezius, levator scapulae, SCM; hold 15-30 sec, 3-5 reps, NRS ≤ 3/10. Therapeutic exercises: cervical deep flexors, scapular stabilization (2-3 sets × 10-15 reps, Borg 11-13), progressed weekly. Modalities: Hot pack 15 min at 40-45°C; TENS 80-100 Hz, 50-100 µs pulse width, 20 min. Frequency: 3× weekly for 6 weeks. Safety: contraindications screened; pain/exertion monitored pre/post.

Первичные конечные точки

• Number of Participants with Reduction in Headache Frequency [Срок оценки: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]
• Mean Change in Pain Intensity (VAS Score, 0-10) [Срок оценки: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]

Вторичные конечные точки (4)

• Change in Cervical ROM (degrees) [Срок оценки: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]
• Mean Difference in Neck Disability Index (NDI) Score [Срок оценки: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]
• Mean Change in SF-36 Quality of Life Score [Срок оценки: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]
• Change in Forward Head Posture (degrees, camera-based measurement) [Срок оценки: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]

Критерии участия

Критерии включения

• Patients aged 18-65 years diagnosed with cervicogenic headache based on the International Classification of Headache Disorders (ICHD-3) criteria.
• Persistent headaches for at least 3 months.
• No previous exposure to low-level laser therapy (LLLT).

Критерии исключения

• Patients with other primary headache disorders (e.g., migraine, tension-type headache).
• History of cervical spine surgery.
• Pregnant or lactating women.
• Patients with a history of photosensitivity or taking photosensitizing medications.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Department of Physiotherapy, Sir Ganga Ram Hospital — Lahore

Публикации

• Bjordal JM, Johnson MI, Iversen V, Aimbire F, Lopes-Martins RA. Low-level laser therapy in acute pain: a systematic review of possible mechanisms of action and clinical effects in randomized placebo-controlled trials. Photomed Laser Surg. 2006 Apr;24(2):158-68. doi: 10.1089/pho.2006.24.158. PMID 16706694

Идентификаторы

NCT: NCT07163208 · 520/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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