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

University of Lahore

Status: Enrolling

Conditions: Cervicogenic Headache

Treatments: Other: Routine Physical Therapy (RPT); Device: Low-Level Laser Therapy (LLLT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07163208

520/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Group 1: 675nm LLLT + RPT

Experimental group

Description:

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.

Treatment:

Device: Low-Level Laser Therapy (LLLT)

Other: Routine Physical Therapy (RPT)

Group 2: 820nm LLLT + RPT

Experimental group

Description:

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.

Treatment:

Device: Low-Level Laser Therapy (LLLT)

Other: Routine Physical Therapy (RPT)

Group 3: 46 Cluster LED Probe + RPT

Experimental group

Description:

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.

Treatment:

Device: Low-Level Laser Therapy (LLLT)

Other: Routine Physical Therapy (RPT)