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Recruiting NCT07163208

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

No phase Interventional Cervicogenic Headache

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-Level Laser Therapy (LLLT), Routine Physical Therapy (RPT).
Who it may be relevant to
Registry conditions: Cervicogenic Headache. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Device Low-Level Laser Therapy (LLLT)
    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.
  • Other Routine Physical Therapy (RPT)
    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 outcome measures

  • Number of Participants with Reduction in Headache Frequency [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]
  • Mean Change in Pain Intensity (VAS Score, 0-10) [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]
Secondary outcome measures (4)
  • Change in Cervical ROM (degrees) [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]
  • Mean Difference in Neck Disability Index (NDI) Score [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]
  • Mean Change in SF-36 Quality of Life Score [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]
  • Change in Forward Head Posture (degrees, camera-based measurement) [Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Department of Physiotherapy, Sir Ganga Ram Hospital — Lahore

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

Identifiers

NCT: NCT07163208 · 520/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗