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Notalgia ParestheticaNCT07356362

High-power Laser Therapy for Notalgia Paresthetica.

A study testing High-power laser in people with Notalgia Paresthetica, run by Uşak University at 1 site in Turkey (Türkiye).

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

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Notalgia Paresthetica
What is being tested?
High-power laser
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Jul 2026to 12 Nov 2026
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

  • 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

Who cannot join

  • - 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

Trial locations and contacts

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

Ali Y Karahan, Prof. contact

+905386921934

ali.karahan@usak.edu.tr

Ender Salbas, Asst. Prof. contact

+905556698639

drendersalbas@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Usak University

    Uşak, 64200

    Ali Y Karahan, Prof, +905386921934, ali.karahan@usak.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effectiveness of High-power Laser Therapy in the Treatment of Notalgia Paresthetica: A Randomised Controlled Study.

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.

Being tested
High-power laser, Sham Laser
Keywords
Laser Therapy, Pain, Itching, Discopathy, Neuropathy
Medical subject headings
Pain, Pruritus

What participants receive

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

  • High-power laserDevice

    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)

  • Sham LaserOther

    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.

Study groups in NCT07356362
Study groupRoleWhat they receive
Experimental Group: High-Power Laser Therapy groupExperimentalMethodology 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).
Receives: Device: High-power laser
Sham Laser GroupSham comparatorThe 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.
Receives: Other: Sham Laser

What is being measured

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

  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.

    Measured: Baseline, 3rd week, 3rd months

Secondary outcomes (1)
  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

    Measured: Baseline, 3rd week, 3rd months

Timeline

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

  1. First posted21 Jan 2026
  2. Study start17 Jul 2026
  3. Primary completion23 Oct 2026 (estimated)
  4. Study completion12 Nov 2026 (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
This is a parallel assignment. It is a controlled trial. Design: This is a prospective randomised study. It is assessor-blinded. It is two-arm parallel-group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07356362
Sponsor's protocol ID
AYK&ES&NS notalgia
Status last verified
Jul 2026
First submitted
12 Jan 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing High-power laser in people with Notalgia Paresthetica, run by Uşak University at 1 site in Turkey (Türkiye).

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 7 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 20 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 Turkey (Türkiye). 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?

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 Ali Y Karahan, Prof. (+905386921934, ali.karahan@usak.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain screening with PainDETECT (time frame: Baseline, 3rd week, 3rd months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Jul 2026.

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