NCT07262697

Brief Summary

Background and Purpose: Neck pain is widespread and stands as the sixth most common cause of disability globally. While laser therapy has been used for many years to treat non-specific neck pain (NNP), there is still a shortage of research directly comparing different laser modalities. The aim of this study was to evaluate and compare the therapeutic effectiveness of low-level laser therapy (LLLT) and high intensity laser therapy (HILT) in managing NNP. Methods: sixty patients diagnosed with NNP were equally randomized into three groups. HILT group received 10 weeks of HILT, LLLT group received 10 weeks of LLLT and a control group that received a home program. Outcome measures were evaluated at baseline and after the intervention period and included pain intensity, neck disability, active cervical range of motion (ROM), and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 18, 2025

Last Update Submit

November 30, 2025

Conditions

Keywords

laserneck painneck disability

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    VAS is a reliable tool for measuring pain intensity. Each participant was asked to mark a point on a 10 cm line corresponding to the severity of their pain, with scores ranging from 0 to 10-where 0 indicates no pain and 10 represents the most severe pain. Previous research has demonstrated that the VAS is a reliable and valid tool for assessing the intensity of neck pain

    10 weeks

Secondary Outcomes (3)

  • Active ROM of the cervical spine

    10 weeks

  • Functional disability

    10 weeks

  • SF-36 Quality of life

    10 weeks

Study Arms (3)

HILT

EXPERIMENTAL

The first phase consisted of rapid manual scanning, delivering a total energy of 1000 J/cm². During the second phase, HILT was applied to eight trigger points, with four applications per point, continuing until pain reduction reached approximately 70-80%; a total of 200 J was delivered in this phase. The final phase was performed with slow manual scanning with the same parameters as the initial phase. The complete HILT procedure lasted around 30 minutes, with a total energy dose of approximately 2050 J (19).

Other: HILTOther: CONTROL

LLLT

EXPERIMENTAL

LLLT sessions were carried out using the diode laser device (Chattanooga Group, USA) of gallium-aluminum-arsenide (GaAlAs, infrared laser) with an 850 nm wavelength, 800 mW power, and constant wave with 1 cm spot size was utilized for the treatment procedures. The laser probe was positioned directly on specific points along the cervical spine while the participant's head remained in a neutral position. Each point was treated for 2 minutes. A total of eight points were marked bilaterally over the trapezius and sternocleidomastoid muscles, covering an area of 24 cm². The total treatment duration was 18 minutes, with an energy dose of 2 J/cm² applied to each point (20).

Other: LLLTOther: CONTROL

CONTROL

ACTIVE COMPARATOR

The home program involved stretching exercises for levator scapulae and upper trapezius, strengthening exercises for neck extensors, and scapular stabilizer exercises. Each exercise was executed with a 5-second hold and 10 repetitions per set, for a total of three sets repeated three times per week for 10 weeks.

Other: CONTROL

Interventions

HILTOTHER

The first phase consisted of rapid manual scanning, delivering a total energy of 1000 J/cm². During the second phase, HILT was applied to eight trigger points, with four applications per point, continuing until pain reduction reached approximately 70-80%; a total of 200 J was delivered in this phase. The final phase was performed with slow manual scanning with the same parameters as the initial phase. The complete HILT procedure lasted around 30 minutes, with a total energy dose of approximately 2050 J (19).

Also known as: Home program
HILT
LLLTOTHER

The laser probe was positioned directly on specific points along the cervical spine while the participant's head remained in a neutral position. Each point was treated for 2 minutes. A total of eight points were marked bilaterally over the trapezius and sternocleidomastoid muscles, covering an area of 24 cm². The total treatment duration was 18 minutes, with an energy dose of 2 J/cm² applied to each point (20).

Also known as: HOME PROGRAM
LLLT
CONTROLOTHER

The home program involved stretching exercises for levator scapulae and upper trapezius, strengthening exercises for neck extensors, and scapular stabilizer exercises. Each exercise was executed with a 5-second hold and 10 repetitions per set, for a total of three sets repeated three times per week for 10 weeks.

CONTROLHILTLLLT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chonic neck pain lasting more than 30 days with no evidence of foraminal compression;
  • age 18 years or older;
  • experiencing considerable pain, stiffness, or discomfort localized to the neck area, without associated numbness or radiation of pain to the upper limbs;
  • a visual analog scale (VAS) pain rating of 3 or above;
  • no therapeutic intervention within the last month

You may not qualify if:

  • Previous cervical spine trauma or surgery;
  • significant cervical disc prolapse, cervical nerve root compression or spinal cord manifestations;
  • history of severe and frequent migraines, fibromyalgia, shoulder diseases, rheumatic or rheumatoid diseases, severe osteoporosis, mental illnesses, significant spinal deformities, or serious cardiovascular, pulmonary, or neurological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Hegazy

Al Kharj, 16242, Saudi Arabia

Location

Related Publications (2)

  • Ezzati K, Laakso EL, Saberi A, Yousefzadeh Chabok S, Nasiri E, Bakhshayesh Eghbali B. A comparative study of the dose-dependent effects of low level and high intensity photobiomodulation (laser) therapy on pain and electrophysiological parameters in patients with carpal tunnel syndrome. Eur J Phys Rehabil Med. 2020 Dec;56(6):733-740. doi: 10.23736/S1973-9087.19.05835-0. Epub 2019 Nov 18.

    PMID: 31742366BACKGROUND
  • Alayat MSM, Alshehri MA, Shousha TM, Abdelgalil AA, Alhasan H, Khayyat OK, Al-Attar WS. The effectiveness of high intensity laser therapy in the management of spinal disorders: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2019;32(6):869-884. doi: 10.3233/BMR-181341.

    PMID: 30932879BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: th
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 4, 2025

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations