Neural Therapy in Notalgia Paresthetica

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.

Study Overview

• Status: Completed
• Conditions: Notalgia Paresthetica
• Intervention / Treatment: Other: Neural Therapy

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

30-60 years old patients with Notalgia Paresthetica

Description

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:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale for Pain	A scale between 0 and 10 was used to question the pain level.	12 weeks after treatment
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.	12 weeks after treatment
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.	12 weeks after treatment
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)	12 weeks after treatment

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: back pain; neuralgia; pruritus; intralesional injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 4446

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No