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Pain ThresholdNCT07422272

Acute Effects of LLLT on Pain Threshold and Pain Tolerance

A study testing Low-Level Laser Therapy (LLLT) in people with Pain Threshold and Pain Tolerance, run by European University of Lefke at 1 site in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Pain Threshold, Pain Tolerance, Acute Pain
What is being tested?
Low-Level Laser Therapy (LLLT)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteCyprus
Study dates
15 Dec 2025to 16 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Cyprus1 site
  • European University of Lefke

    Lefka, Northern Cyprus, 99780

Other trials in Cyprus

About this study

Official title: Examining of the Acute Effects of Low-Level Laser Therapy (LLLT) on Pain Threshold and Tolerance: a Randomized Controlled Trial

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.

Read the detailed description

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." Pain can be classified into several types: nociceptive pain, neuropathic pain, and nociplastic pain. Nociceptive pain results from actual or potential damage to non-neural tissue and is due to the activation of nociceptors. It is typically acute and arises from injury, inflammation, or mechanical stimuli. Neuropathic pain is caused by damage or disease affecting the somatosensory nervous system. Nociplastic pain involves altered nociception despite no clear evidence of tissue damage or nerve injury.

Acute nociceptive pain is one of the most common presentations in musculoskeletal conditions and plays a crucial protective role by alerting the body to tissue damage and prompting healing responses. However, when inadequately controlled, it may induce central sensitisation and predispose patients to chronic pain syndromes. To address acute pain non-pharmacologically, physiotherapists typically employ a multimodal approach, including Transcutaneous Electrical Nerve Stimulation (TENS), which harnesses sensory-level stimulation to activate spinal inhibitory circuits and dampen pain signals; therapeutic ultrasound (US), where mechanical vibration and mild thermal effects accelerate inflammatory resolution and collagen synthesis; cryotherapy and thermotherapy, which modulate local tissue temperature to reduce nociceptor excitability and optimize perfusion; and manual therapy, including joint mobilization, soft tissue techniques, and muscle energy methods, that elicit both mechanical and neurophysiological analgesia, improving range of motion and function.

More recently, laser therapy has emerged as a powerful adjunct for acute pain relief. Laser therapy refers to the medical use of specific light wavelengths to elicit therapeutic effects in tissues. Broadly, there are two main types used in physiotherapy: High-Intensity Laser Therapy (HILT) and Low-Level Laser Therapy (LLLT). HILT operates at higher power outputs and can penetrate deeper tissues, producing photothermal effects. In contrast, LLLT, also termed photobiomodulation or cold laser therapy, uses lower power levels and longer exposure times, primarily inducing photochemical and photobiological changes without significant heating. LLLT is favoured for its safety and gentle stimulation of tissue repair across a wide range of conditions.

LLLT involves the application of red or near-infrared light, typically between 600 and 1100 nm, at low intensities to avoid thermal effects. It has been widely adopted in clinical practice due to its non-invasive nature, minimal side effects, and effectiveness in reducing pain, promoting wound healing, and modulating inflammation.

The mechanisms underlying LLLT are thought to involve the absorption of photons by cellular chromophores, particularly cytochrome c oxidase in the mitochondria. This enhances mitochondrial respiration and ATP production, modulates reactive oxygen species, and induces transcription factors that promote cell survival and tissue repair. These effects may also extend to modulation of the autonomic nervous system, where LLLT has been shown to promote parasympathetic activity and reduce sympathetic dominance, contributing to analgesic and anti-inflammatory outcomes.

In clinical research, participants' expectations can influence perceived outcomes, a phenomenon known as the placebo effect. Placebo responses can elicit real neurophysiological changes, including activation of endogenous opioid and dopamine pathways and modulation of pain-related brain regions . To differentiate the specific effects of LLLT from expectancy-driven improvements, a sham-controlled design is essential, where participants undergo an identical procedure without therapeutic laser emission.

Despite the growing use of LLLT for pain management, there remains a research gap regarding its immediate effects on pain perception in healthy individuals. Much of the existing evidence focuses on chronic pain populations or multiple-session interventions. It remains unclear whether a single application of LLLT can immediately alter pain threshold or pain tolerance. Pain threshold is the lowest intensity at which a stimulus is perceived as painful, while pain tolerance is the maximum intensity an individual can endure. These measures provide complementary and objective indices of analgesic effects.

This study focuses on nociceptive pain in healthy adults, using standardised external stimulation to assess changes in pain threshold and pain tolerance following a single session of LLLT compared to a sham control.

Aim:

To assess the immediate effect of a single session of Low-Level Laser Therapy (LLLT) versus sham control on pain threshold and pain tolerance in healthy adults.

Being tested
Low-Level Laser Therapy (LLLT), Sham LLLT
Keywords
Low-Level Laser Therapy LLLT, Photobiomodulation, Acute Pain, Pain Threshold, Pain Tolerance, Sham Laser, Analgesic Effect, Randomized Controlled Trial, Physiotherapy Modalities
Medical subject headings
Acute 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

    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.

  • 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.

Study groups in NCT07422272
Study groupRoleWhat they receive
Low-Level Laser Therapy (LLLT)ExperimentalParticipants 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.
Receives: Device: Low-Level Laser Therapy (LLLT)
Sham LLLTPlacebo comparatorParticipants 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.
Receives: Other: Sham LLLT

What is being measured

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

  1. 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.

    Measured: Pre-intervention and immediately post-intervention

  2. 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.

    Measured: Pre-intervention and immediately post-intervention

Timeline

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

  1. First posted19 Feb 2026
  2. Study start15 Dec 2025
  3. Primary completion16 Apr 2026
  4. Study completion16 Apr 2026

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, sham-controlled, parallel-group, two-arm superiority design with 1:1 allocation.
Masking
Single blind
Who is masked
Participant
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07422272
Sponsor's protocol ID
BAYEK057.11
Status last verified
Jun 2026
First submitted
20 Jan 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

  • 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

  • Hashmi JT, Huang YY, Sharma SK, Kurup DB, De Taboada L, Carroll JD, Hamblin MR. Effect of pulsing in low-level light therapy. Lasers Surg Med. 2010 Aug;42(6):450-66. doi: 10.1002/lsm.20950.

    PubMed 20662021
  • Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.

    PubMed 28748217
  • Fan T, Li Y, Wong AYL, Liang X, Yuan Y, Xia P, Yao Z, Wang D, Pang MYC, Ding C, Zhu Z, Li Y, 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 Clin Exp Res. 2024 Oct 5;36(1):203. doi: 10.1007/s40520-024-02853-0.

    PubMed 39367994
  • 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

  • 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

  • Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13.

    PubMed 19913903
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Low-Level Laser Therapy (LLLT) in people with Pain Threshold and Pain Tolerance, run by European University of Lefke at 1 site in Cyprus.

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 5 inclusion and 9 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: finished, as of the sponsor's last update on 2 Jul 2026. 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 Cyprus. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electrical Pain Threshold Intensity (mA) (time frame: Pre-intervention and immediately post-intervention). 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 NCT07422272, which also lists 9 linked publications.

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 2 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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