High-power Laser Therapy for Notalgia Paresthetica.

NCT07356362 | Not Yet Recruiting

• 1 other identifier: AYK&ES&NS notalgia
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Notalgia Paresthetica

Keywords

Laser Therapy; Pain; Itching; Discopathy; Neuropathy

Outcome Measures

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.

  Baseline, 3rd week, 3rd months

Secondary Outcomes (1)

• Pruritus Intensity

  Baseline, 3rd week, 3rd months

Study Arms (2)

Experimental Group: High-Power Laser Therapy group

EXPERIMENTAL

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 Laser Group

SHAM COMPARATOR

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

High-power laser DEVICE

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)

Experimental Group: High-Power Laser Therapy group

Sham Laser OTHER

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.

Sham Laser Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Uşak University: lead
• Balikesir University: collaborator

MeSH Terms

Conditions

Pain; Pruritus

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Study Officials

• Ender Y Salbas, Asst. Prof.

  University of Balikesir

  STUDY CHAIR

Central Study Contacts

Ali Y Karahan, Prof.

CONTACT

+905386921934; ali.karahan@usak.edu.tr

Ender Salbas, Asst. Prof.

CONTACT

+905556698639; drendersalbas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded. The clinician conducting the outcome assessments will be unaware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): November 12, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01