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CompletedNCT06508073Updated Jul 18, 2024

Neural Therapy in Notalgia Paresthetica

An observational study in Notalgia Paresthetica, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
12
Ages
30 Years to 60 Years
Sex
All
01

Study summary

Patients diagnosed with Notalgia paresthetica and who received neural therapy within the last year were retrospectively screened. In the evaluations before treatment and at the 3rd month after treatment; Numerical rating scale for pain, PainDETECT questionnaire for neuropathic pain, SF-12 for quality of life and 5-D itch scale for itch level were used.

02

Conditions studied

  • Notalgia Paresthetica

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Keywords

  • back pain
  • intralesional injection
  • neuralgia
  • pruritus
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 12 is below the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 110 studies on the registry; 14 are open to participants now.

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

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

30-60 years old patients with Notalgia Paresthetica

Inclusion criteria

  • the presence of a hyperpigmented skin lesion consistent with NP
  • minimum 6 months for duration of disease
  • 30-60 aged
  • application of neural therapy in a manner appropriate to the diagnosis

Exclusion criteria

Exclusion Criteria:

  • history of previous surgery or injection in the thoracic region
  • presence of another treatment in the same period
  • presence of any cardiac or pulmonary disease, malignancy, or advanced psychiatric disease
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
12 participants (actual)
Patient registry
No

Interventions

  • OtherNeural Therapy

    The injection was prepared using a solution of lidocaine 2% and saline 0.9%. A 0.4% lidocaine solution was prepared by diluting 1 cc of lidocaine with 4 cc of saline.

06

What researchers measure

Primary outcomes

  1. Numeric Rating Scale for Pain

    A scale between 0 and 10 was used to question the pain level.

    Time frame: 12 weeks after treatment

  2. PainDETECT Questionnaire for assessing Neuropathic pain

    The questionnaire consists of 9 items and is completed by the patient (no clinical examination is required)\[1\]\[3\]. There are 7 weighted sensory descriptor items (never to very strongly) and 2 items relating to spatial and temporal pain characteristics\[3\]. A total score of 19 or more is indicative of likely neuropathic pain.

    Time frame: 12 weeks after treatment

  3. Short Form-12 for Quality of life

    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.

    Time frame: 12 weeks after treatment

  4. 5-D Itch Scale

    The 5-D itch scale is a 5-domain disease-specific instrument evaluating the duration, degree (severity), direction (improving, unaltered or worsening), disability (impact on sleep, leisure/social, housework/errands and school/work activities) and distribution (body part affected)

    Time frame: 12 weeks after treatment

07

Study locations

1 site
  • University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
    Istanbul, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06508073
Lead sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible party
Aylin Ayyıldız (Medical Doctor, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Jul 18, 2024
Start date
Jun 26, 2024
Primary completion
Jul 10, 2024
Completion
Jul 10, 2024
Last update
Jul 18, 2024

Oversight

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

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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