High-power Laser Therapy for Notalgia Paresthetica.

ConditionNotalgia Paresthetica

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUşak University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

- 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

Trial design

Design model

Parallel

Treatments tested in this trial

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)
Sham Laser
Other intervention
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Experimental Group: High-Power Laser Therapy groupExperimental treatment 1 intervention

Group B: Sham Laser GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uşak University

Lead sponsor

Balikesir University

Collaborator

Source ClinicalTrials.gov

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