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RecruitingNCT07356362Updated Jul 20, 2026

High-power Laser Therapy for Notalgia Paresthetica.

An interventional study of High-power laser and Sham Laser in Notalgia Paresthetica, sponsored by Uşak University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Uşak University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A non-invasive modality for the management of neuromusculoskeletal pain conditions that has emerged as a compelling option is high-power laser therapy (HPLT). The pathophysiology of notalgia paresthetica (NP) is treated uniquely by HPLT, which targets both the presumed muscular component of nerve entrapment and the resultant neuropathic symptoms. The main goal of this study, which is randomised, controlled and blinded by assessors, is to find out how well High-Power Laser Therapy (HPLT) works as an extra treatment to standard care in reducing itching, pain and improving quality of life for patients with long-term nerve pain.

Read the detailed description

Notalgia Paresthetica (NP) is a sensory mononeuropathy characterized by a well-circumscribed area of pruritus, paresthesia, burning pain, and hyperpigmentation on the medial aspect of the scapular and infrascapular regions. The condition results from the entrapment or compression of the posterior rami of the thoracic spinal nerves T2 through T6 as they traverse through the multifidus spinae muscle, making a sharp turn to penetrate the fascia of the back muscles. This anatomical vulnerability creates a predisposition to nerve irritation, leading to the characteristic symptoms. NP is often chronic and recalcitrant to treatment, with significant negative impacts on sleep, daily activities, and quality of life.

The current management of NP is challenging and often unsatisfactory. First-line treatments typically include topical agents such as capsaicin cream, topical anesthetics, or corticosteroids to alleviate localized symptoms. For more persistent cases, systemic medications like gabapentinoids or tricyclic antidepressants may be employed, though their efficacy is variable and side effects can be limiting. Interventional procedures, including trigger point injections with anesthetics and corticosteroids, or botulinum toxin A injections, have shown promise by targeting the underlying muscular entrapment. However, the evidence base for these interventions remains limited, consisting largely of case reports and small series, highlighting a significant gap in the availability of effective, non-invasive, and well-tolerated therapeutic options.

High-Power Laser Therapy (HPLT) has emerged as a compelling non-invasive modality for the management of neuromusculoskeletal pain conditions. Operating at power outputs typically between 1 and 15 Watts, HPLT utilizes wavelengths (e.g., 980 nm, 1064 nm) that provide deep tissue penetration, reaching the affected neurovascular structures beneath the thick paraspinal musculature. The therapeutic mechanisms of HPLT are multifactorial, combining significant photothermal effects with photobiomodulation. These include deep tissue analgesia, reduction of inflammation and edema, relaxation of hypertonic muscles, enhanced microcirculation, and stimulation of nerve repair processes. By targeting both the presumed muscular component of nerve entrapment and the resultant neuropathic symptoms, HPLT presents a uniquely suited, non-pharmacological intervention for the pathophysiology of NP.

Despite the growing body of evidence supporting HPLT for various entrapment neuropathies, such as meralgia paresthetica, its application specifically for Notalgia Paresthetica remains largely unexplored. A rigorous, controlled investigation is necessary to determine its clinical value and establish it as a viable treatment option.

Aim of the Study

The primary aim of this randomized, sham-controlled, assessor-blinded study is to investigate the efficacy of High-Power Laser Therapy (HPLT) as an adjunct to standard care on pruritus intensity, pain, and quality of life in patients with chronic Notalgia Paresthetica.

This study hypothesize that patients receiving active HPLT will demonstrate significantly greater reduction in pruritus and pain scores, alongside greater improvement in quality of life, compared to those receiving a sham laser procedure.

02

Conditions studied

  • Notalgia Paresthetica

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Keywords

  • Laser Therapy
  • Pain
  • Itching
  • Discopathy
  • Neuropathy
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 40 is below the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Uşak University is the lead sponsor of 80 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-75 years
  • Clinical diagnosis of unilateral Notalgia Paresthetica for at least 3 months
  • Presence of characteristic symptoms (pruritus, paresthesia, and/or burning pain) in the typical T2-T6 dermatomal distribution
  • A minimum score of 4 on the Numeric Rating Scale (NRS) for pruritus intensity
  • Presence of hyperpigmentation in the affected area

Exclusion criteria

Exclusion Criteria:

  • - Secondary causes of symptoms (e.g., spinal pathology, herpes zoster, renal failure)
  • Previous spinal surgery in the thoracic region
  • Coagulopathy or use of anticoagulant medication
  • Skin diseases or infections in the treatment area
  • Pregnancy or lactation
  • Cognitive impairment affecting ability to complete questionnaires
  • Previous treatment with botulinum toxin in the affected area within 6 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Experimental Group: High-Power Laser Therapy group

    Methodology for application, method for scanning, the laser probe will be shifted gradually and without interruption over the whole length of the LFCN (from just the medial and inferior aspects of the ASIS, distally along the thigh).

    Device: High-power laser

  • Sham comparator
    Sham Laser Group

    The procedure is the same as Group 1, but without the therapeutic energy emitted by the sham laser applicator. The device will make a beeping sound and show a display as if it is functioning.

    Other: Sham Laser

Interventions

  • DeviceHigh-power laser

    Wavelength: 1064 nm Output power: 10 W (continuous wave) Spot size: 8 cm² Energy density: 100 J/cm² per session Application technique: The laser probe will be applied using a scanning technique over the affected dermatomal area and the corresponding paravertebral muscles from T2 to T6 levels. Treatment duration: 10 minutes per session Frequency: 3 sessions per week for 4 weeks (total 12 sessions)

  • OtherSham Laser

    Participants will receive identical positioning and procedures as the experimental group, using the same laser device with a sham applicator that emits no therapeutic energy. The device will display active operation and produce typical sounds to maintain blinding.

06

What researchers measure

Primary outcomes

  1. Pain screening with PainDETECT

    PainDETECT screening questionnaire: PainDETECT is a simple, easy to use screening questionnaire. The questionnaire consists of 9 items and is completed by the patient (no clinical examination is required). There are 7 weighted sensory descriptor items (never to very strongly) and 2 items relating to spatial and temporal pain characteristics. A total score of 19 or more is indicative of likely neuropathic pain.

    Time frame: Baseline, 3rd week, 3rd months

Secondary outcomes

  1. Pruritus Intensity

    Measured using the Numeric Rating Scale (NRS) for pruritus. It can be interpreted as follows: Score 0 = no pruritus Score \< 3 = mild pruritus Score ≥3\<7 = moderate pruritus Score ≥7\<9 = severe pruritus Score ≥9 = very severe pruritus

    Time frame: Baseline, 3rd week, 3rd months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Oct 2026, 3 months after the start.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 3 months is below that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2026
First posted
Jan 21, 2026
StartActual
Jul 17, 2026
Primary completionEst.
Oct 23, 2026
CompletionEst.
Nov 12, 2026
Last update
Jul 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07356362
Lead sponsor
Uşak University
Collaborators
Balikesir University
Responsible party
Sponsor
First posted
Jan 21, 2026
Start date
Jul 17, 2026
Primary completion
Oct 23, 2026 (estimated)
Completion
Nov 12, 2026 (estimated)
Last update
Jul 20, 2026

Study contacts

Ali Y Karahan, Prof.
Contact
ali.karahan@usak.edu.tr
+905386921934
Ender Salbas, Asst. Prof.
Contact
drendersalbas@gmail.com
+905556698639
Ender Y Salbas, Asst. Prof.
study chair · University of Balikesir

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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