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NCT Number: NCT07163208

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Low-level laser therapy (LLLT)

Device

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.

Routine Physical Therapy (RPT)

Other

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.

Primary outcomes

  1. Number of Participants with Reduction in Headache Frequency

    Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

    Measured by patient diary recording

  2. Mean Change in Pain Intensity (VAS Score, 0-10)

    Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

    Measured by Visual Analog Scale (VAS, 0-10)

Secondary outcomes

  1. Change in Cervical ROM (degrees)

    Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

    Measured by universal goniometer

  2. Mean Difference in Neck Disability Index (NDI) Score

    Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

    Measured by Neck Disability Index (NDI, Urdu version)

  3. Mean Change in SF-36 Quality of Life Score

    Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

    Measured by Short Form Health Survey (SF-36)

  4. Change in Forward Head Posture (degrees, camera-based measurement)

    Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

    Measured by mobile camera picture, degree

Study contacts

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

AROOJ MUNAWAR, MS

CONTACT

[email protected]

00923214746780

Umair Ahmed, PhD

CONTACT

[email protected]

00923212700817

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Acronym: WELL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Sep 19, 2025

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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