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

NCT07163208 | Recruiting DMC

• 1 other identifier: 520/24
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervicogenic Headache

Keywords

Cervicogenic Headache; Low-Level Laser Therapy; Neck Pain

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Reduction in Headache Frequency

  Measured by patient diary recording

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months

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

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

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months

Secondary Outcomes (4)

• Change in Cervical ROM (degrees)

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months

• Mean Difference in Neck Disability Index (NDI) Score

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months

• Mean Change in SF-36 Quality of Life Score

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months

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

  Baseline, 3 weeks, 6 weeks, 3 months, 6 months

Study Arms (3)

Group 1: 675nm LLLT + RPT

EXPERIMENTAL

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.

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

Group 2: 820nm LLLT + RPT

EXPERIMENTAL

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.

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

Group 3: 46 Cluster LED Probe + RPT

EXPERIMENTAL

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.

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

Interventions

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.

Group 1: 675nm LLLT + RPT; Group 2: 820nm LLLT + RPT; Group 3: 46 Cluster LED Probe + RPT

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.

Group 1: 675nm LLLT + RPT; Group 2: 820nm LLLT + RPT; Group 3: 46 Cluster LED Probe + RPT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Department of Physiotherapy, Sir Ganga Ram Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache; Neck Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Umair Ahmed, PhD

  University of Lahore, Lahore, Pakistan

  STUDY DIRECTOR

Central Study Contacts

AROOJ MUNAWAR, MS

CONTACT

00923214746780; arooj.munawar@uipt.uol.edu.pk

Umair Ahmed, PhD

CONTACT

00923212700817; umair.ahmed@uipt.uol.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In addition to participants and outcomes assessors being masked, care providers administering the low-level laser therapy (LLLT) interventions are also blinded to the specific wavelength or modality (675nm, 820nm, or 46-cluster LED probe) assigned to each group to minimize bias in treatment delivery, ensuring the study's integrity across all three parallel experimental groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three parallel groups receive different LLLT wavelengths (675nm, 820nm, 46-cluster LED) plus routine physical therapy, assessed at baseline, 3 weeks, 6 weeks, and follow-ups

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start: September 5, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 5, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available beginning 6 months after publication of the main trial results and will remain accessible for 5 years thereafter.
• Access Criteria: Qualified researchers affiliated with academic institutions or healthcare organizations may request access. Proposals will be reviewed by the principal investigator and supervisory team to ensure scientific merit and compliance with ethical approvals. Data will be shared in de-identified format only through a secure data repository (encrypted file transfer or institutional repository) after signing a data-sharing agreement.

Locations

PA (1)