NCT07422272

Brief Summary

Pain is defined by the International Association for the Study of Pain as "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage." Low-Level Laser Therapy (LLLT) has gained attention as a safe, noninvasive intervention with analgesic and anti-inflammatory effects. This study examines whether a single session of LLLT can produce immediate changes in pain threshold and pain tolerance in healthy adults, compared to a sham laser control.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 20, 2026

Last Update Submit

February 12, 2026

Conditions

Pain ThresholdPain ToleranceAcute PainLow-level Laser TherapyLLLT vs Sham

Keywords

Low-Level Laser Therapy LLLTPhotobiomodulationAcute PainPain ThresholdPain ToleranceSham LaserAnalgesic EffectRandomized Controlled TrialPhysiotherapy Modalities

Outcome Measures

Primary Outcomes (2)

  • Electrical Pain Threshold Intensity (mA)

    Electrical pain threshold will be measured using tetanic faradic stimulation with gradual increases in current intensity. The cathode will be placed on the palmar surface of the third finger and the anode over the medial epicondyle. Participants will verbally indicate the point at which the electrical sensation is first perceived as painful. The stimulation intensity (in milliamperes) at this point will be recorded.

    Pre-intervention and immediately post-intervention

  • Electrical Pain Tolerance Intensity (mA)

    Electrical pain tolerance will be measured using tetanic faradic stimulation using the same electrode placement and stimulation parameters. Participants will verbally indicate the maximum level of pain they are willing to tolerate. The stimulation intensity (in milliamperes) at this point will be recorded.

    Pre-intervention and immediately post-intervention

Study Arms (2)

Low-Level Laser Therapy (LLLT)

EXPERIMENTAL

Participants in this group will receive active Low-Level Laser Therapy (LLLT) using a 904 nm wavelength Chattanooga model 422 laser device at 1000 Hz. The laser will be applied for 2 minutes per point to three standardized points over the medial epicondyle region (total of 6 minutes). The energy dose is 0.9 J/cm². All participants and the researcher will wear appropriate laser safety eyewear.

Device: Low-Level Laser Therapy (LLLT)

Sham LLLT

PLACEBO COMPARATOR

Participants in this group will undergo the same procedure, positioning, device placement, application duration, and safety eyewear use as the active LLLT group; however, the laser device will be deactivated. No therapeutic light energy will be delivered. This sham procedure is used to control for placebo and expectation effects.

Other: Sham LLLT

Interventions

Low-Level Laser Therapy (LLLT)DEVICE

Active LLLT delivered via a 904 nm wavelength Chattanooga model 422 laser at 1000 Hz with a dosage of 0.9 J/cm². The laser is applied for 2 minutes per point over three standardized points near the medial epicondyle (total duration 6 minutes). Standard laser safety eyewear used for both participant and researcher.

Low-Level Laser Therapy (LLLT)
Sham LLLTOTHER

This is a sham comparator intervention. The procedure replicates the active Low-Level Laser Therapy (LLLT) protocol, including device placement, duration (6 minutes), and use of laser safety eyewear. However, the laser emission is deactivated, and no therapeutic light energy is delivered.

Sham LLLT

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 35 years
  • Healthy individuals without chronic medical conditions
  • Free from chronic or acute pain
  • All genders
  • Able to provide informed consent

You may not qualify if:

  • Menstruation at the time of testing
  • Sensory deficits (failure to pass sharp-dull test)
  • Pregnancy
  • History of epilepsy
  • Presence of cardiovascular conditions (including pacemaker)
  • Acute hand injuries
  • Diagnosed neurological disorders
  • Use of analgesics or NSAIDs within the previous 48 hours
  • Contraindications to low-level laser therapy or electrical stimulation (e.g., light sensitivity, malignancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University of Lefke

Lefka, Northern Cyprus, 99780, Cyprus

RECRUITING

Related Publications (9)

  • World Health Organization (WHO). Safety guidelines for low-level laser therapy. WHO Press; 2017.

    BACKGROUND

  • International Association for the Study of Pain (IASP). IASP announces revised definition of pain. 2020. https://www.iasp-pain.org/publications/news/announcement-of-revised-definition-of-pain

    BACKGROUND

  • Hashmi JT, Huang YY, Sharma SK, Kurup DB, De Taboada L, Carroll JD, Hamblin MR. Effect of pulsing in low-level light therapy. Lasers in Surgery and Medicine. 2010;42(6):450-466. https://doi.org/10.1002/lsm.20950

    BACKGROUND

  • Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophysics. 2016;3(3):337-361. https://doi.org/10.3934/biophy.2016.3.337

    BACKGROUND

  • Fan T, Li Y, Wong AYL, Liang X, Yuan Y, Xia P, Fu SN. A systematic review and network meta-analysis on the optimal wavelength of low-level light therapy (LLLT) in treating knee osteoarthritis symptoms. Aging Clinical and Experimental Research. 2024;36(1):203-212. https://doi.org/10.1007/s40520-024-02853-0

    BACKGROUND

  • Glazov G, Yelland M, Emery J. Low-level laser therapy for chronic non-specific low back pain: A systematic review and meta-analysis. Lasers in Medical Science. 2021;36(2):249-259. https://doi.org/10.1007/s10103-020-03172-2

    BACKGROUND

  • Dundar U, Turkmen U, Toktas H, Ulasli AM, Solak O, Evcik D. Effect of low-level laser therapy on pain and function in patients with knee osteoarthritis: A double-blind, randomized controlled trial. Lasers in Medical Science. 2015;30(7):2327-2333. https://doi.org/10.1007/s10103-015-1806-5

    BACKGROUND

  • Chow RT, Johnson MI, Lopes-Martins RAB, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: A systematic review and meta-analysis of randomized placebo- or active-treatment-controlled trials. The Lancet. 2009;374(9705):1897-1908. https://doi.org/10.1016/S0140-6736(09)61522-1

    BACKGROUND

  • Alfredo PP, Bjordal JM, Dreyer SH, Meneguzzo DT, Pagnoncelli RM, Lopes-Martins RAB. Efficacy of low-level laser therapy associated with exercises in the treatment of shoulder disorders: A randomized controlled trial. Clinical Rehabilitation. 2009;23(9):889-897. https://doi.org/10.1177/0269215509337440

    BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Asst. Prof. Dr. Beraat Alptuğ

    European University of Lefke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yara Mabrouk Houtar

CONTACT

+905338875012yaramabrouk334@gmail.com

Asst. Prof. Dr. Beraat Alptuğ Alptuğ

CONTACT

balptug@eul.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants blinded to group assignment. Researcher administering intervention unblinded; participants wear safety glasses in both groups to maintain blinding.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized, sham-controlled, parallel-group, two-arm superiority design with 1:1 allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 19, 2026

Study Start

December 15, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

CY(1)