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Cervicogenic HeadacheWELLNCT07163208

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

A study testing Low-Level Laser Therapy (LLLT) and Routine Physical Therapy (RPT) in people with Cervicogenic Headache, run by University of Lahore at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cervicogenic Headache
What is being tested?
Low-Level Laser Therapy (LLLT) and Routine Physical Therapy (RPT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 sitePakistan
Study dates
5 Sep 2024to 5 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan1 site, 1 recruiting
  • Department of Physiotherapy, Sir Ganga Ram Hospital

    Lahore, Punjab Province, 54000

    Arooj Munawar, MSOMPT, 00923214746780, arooj.munawar@uipt.uol.edu.pk

    Umair Ahmed, PhD, 00923212700817, umair.ahmed@uipt.uol.edu.pk

    Recruiting

Other trials in Pakistan

About this study

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.

Read the 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.

Being tested
Low-Level Laser Therapy (LLLT), Routine Physical Therapy (RPT)
Keywords
Cervicogenic Headache, Low-Level Laser Therapy, Neck Pain
Medical subject headings
Post-Traumatic Headache, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07163208
Study groupRoleWhat they receive
Group 1: 675nm LLLT + RPTExperimentalSingle 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.
Receives: Device: Low-Level Laser Therapy (LLLT); Other: Routine Physical Therapy (RPT)
Group 2: 820nm LLLT + RPTExperimentalSingle 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.
Receives: Device: Low-Level Laser Therapy (LLLT); Other: Routine Physical Therapy (RPT)
Group 3: 46 Cluster LED Probe + RPTExperimental46-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.
Receives: Device: Low-Level Laser Therapy (LLLT); Other: Routine Physical Therapy (RPT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Reduction in Headache Frequency

    Measured by patient diary recording

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

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

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

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

Secondary outcomes (4)
  1. Change in Cervical ROM (degrees)

    Measured by universal goniometer

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

  2. Mean Difference in Neck Disability Index (NDI) Score

    Measured by Neck Disability Index (NDI, Urdu version)

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

  3. Mean Change in SF-36 Quality of Life Score

    Measured by Short Form Health Survey (SF-36)

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

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

    Measured by mobile camera picture, degree

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start5 Sep 2024
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion5 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07163208
Sponsor's protocol ID
520/24
Acronym
WELL
Status last verified
Sep 2025
First submitted
31 Aug 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcome results will be shared, including baseline demographic and clinical characteristics, pain scores (VAS), headache frequency, Neck Disability Index (NDI), cervical ROM, SF-36 quality of life measures, and forward head posture assessments.

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.

    PubMed 16706694

Questions about this trial

What is this clinical trial studying?

A study testing Low-Level Laser Therapy (LLLT) and Routine Physical Therapy (RPT) in people with Cervicogenic Headache, run by University of Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AROOJ MUNAWAR, MS (00923214746780, arooj.munawar@uipt.uol.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Reduction in Headache Frequency (time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07163208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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