Neural Therapy in Notalgia Paresthetica

NCT06508073 | Completed

• 1 other identifier: 4446
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Notalgia Paresthetica

Keywords

back pain; intralesional injection; neuralgia; pruritus

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Neural Therapy OTHER

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.

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

30-60 years old patients with Notalgia Paresthetica

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Back Pain; Neuralgia; Pruritus

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: June 26, 2024
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

TU (1)