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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07163208
Acronym
WELL
Enrollment
150
Registered
2025-09-09
Start date
2024-09-05
Completion date
2025-10-05
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervicogenic Headache

Keywords

Cervicogenic Headache, Low-Level Laser Therapy, Neck Pain

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.

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.

Interventions

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.

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.

Sponsors

University of Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Reduction in Headache FrequencyBaseline, 3 weeks, 6 weeks, 3 months, 6 monthsMeasured by patient diary recording
Mean Change in Pain Intensity (VAS Score, 0-10)Baseline, 3 weeks, 6 weeks, 3 months, 6 monthsMeasured by Visual Analog Scale (VAS, 0-10)

Secondary

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

Countries

Pakistan

Contacts

Primary ContactAROOJ MUNAWAR, MS
arooj.munawar@uipt.uol.edu.pk00923214746780
Backup ContactUmair Ahmed, PhD
umair.ahmed@uipt.uol.edu.pk00923212700817

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026