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

NCT07163208 — Not applicable, Recruiting, 150 participants, University of Lahore

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Registry	NCT07163208, acronym WELL
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	150 (Estimated)
Sponsor	University of Lahore (Other)
Conditions	Cervicogenic Headache
Interventions	Low-Level Laser Therapy (LLLT), Routine Physical Therapy (RPT) (Device, other)
Dates	start 2024-09-05, primary completion 2025-09-30 (estimated), completion 2025-10-05 (estimated), first posted 2025-09-09, last updated 2025-09-19
Locations	1 site in Pakistan

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Group 1: 675nm LLLT + RPT	Experimental	Device: Low-Level Laser Therapy (LLLT); Other: Routine Physical Therapy (RPT)	Single direct in-contact pencil probe, wavelength 675 nm, power 30 mW. Irradiance 222 mW/cm², fluence 6.7 J/cm², spot size 0.9 cm². Delivered in continuous and pulsed (2.5 Hz) modes, 6 Joules for 30 sec per treatment point (lymphatic chain, sub-occipital musculature, facet joints, nerve root exits, trigger points). Administered 3× weekly for 6 weeks (30 min/session). Device: Omega XP Model, Omega Laser Systems (UK) Class II therapeutic photobiomodulation device. Equipped with single direct in-contact pencil probes (675 nm, 30 mW; 820 nm, 200 mW) and a 46-cluster LED probe (mixed diodes 660-950 nm). Operates in continuous and pulsed (2.5 Hz) modes. Spot size 0.9-10 cm², irradiance 95-222 mW/cm², fluence 6.7-11.4 J/cm². CE-certified for therapeutic use; applied in this trial for cervicogenic headache management.
Group 2: 820nm LLLT + RPT	Experimental	Device: Low-Level Laser Therapy (LLLT); Other: Routine Physical Therapy (RPT)	Single direct in-contact pencil probe, wavelength 820 nm, power 200 mW. Irradiance 222 mW/cm², fluence 6.7 J/cm², spot size 0.9 cm². Delivered in continuous and pulsed (2.5 Hz) modes, 6 Joules for 30 sec per treatment point (same anatomical sites as Group 1). Administered 3× weekly for 6 weeks (30 min/session). Device: Omega XP Model, Omega Laser Systems (UK) Class II therapeutic photobiomodulation device. Equipped with single direct in-contact pencil probes (675 nm, 30 mW; 820 nm, 200 mW) and a 46-cluster LED probe (mixed diodes 660-950 nm). Operates in continuous and pulsed (2.5 Hz) modes. Spot size 0.9-10 cm², irradiance 95-222 mW/cm², fluence 6.7-11.4 J/cm². CE-certified for therapeutic use; applied in this trial for cervicogenic headache management.
Group 3: 46 Cluster LED Probe + RPT	Experimental	Device: Low-Level Laser Therapy (LLLT); Other: Routine Physical Therapy (RPT)	46-cluster LED probe combining 660 nm, 950 nm, 870 nm, 880 nm, 940 nm, 820 nm. Irradiance 95 mW/cm², fluence 11.4 J/cm², spot size 10 cm². Delivered in continuous and pulsed (2.5 Hz) modes, 114 Joules for 120 sec per treatment area (same anatomical sites as above). Administered 3× weekly for 6 weeks (30 min/session). Device: Omega XP Model, Omega Laser Systems (UK) Class II therapeutic photobiomodulation device. Equipped with single direct in-contact pencil probes (675 nm, 30 mW; 820 nm, 200 mW) and a 46-cluster LED probe (mixed diodes 660-950 nm). Operates in continuous and pulsed (2.5 Hz) modes. Spot size 0.9-10 cm², irradiance 95-222 mW/cm², fluence 6.7-11.4 J/cm². CE-certified for therapeutic use; applied in this trial for cervicogenic headache management.

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.

+Outcome measures

Primary outcomes

Number of Participants with Reduction in Headache Frequency [Baseline, 3 weeks, 6 weeks, 3 months, 6 months]: Measured by patient diary recording
Mean Change in Pain Intensity (VAS Score, 0-10) [Baseline, 3 weeks, 6 weeks, 3 months, 6 months]: Measured by Visual Analog Scale (VAS, 0-10)

Secondary outcomes

Change in Cervical ROM (degrees) [Baseline, 3 weeks, 6 weeks, 3 months, 6 months]: Measured by universal goniometer
Mean Difference in Neck Disability Index (NDI) Score [Baseline, 3 weeks, 6 weeks, 3 months, 6 months]: Measured by Neck Disability Index (NDI, Urdu version)
Mean Change in SF-36 Quality of Life Score [Baseline, 3 weeks, 6 weeks, 3 months, 6 months]: Measured by Short Form Health Survey (SF-36)
Change in Forward Head Posture (degrees, camera-based measurement) [Baseline, 3 weeks, 6 weeks, 3 months, 6 months]: Measured by mobile camera picture, degree

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
Department of Physiotherapy, Sir Ganga Ram Hospital	Lahore, Punjab Province	Pakistan	Recruiting

+Publications

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

+Investigators

Umair Ahmed, PhD, Study director, University of Lahore, Lahore, Pakistan

My Notes

Public

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