NCT07206680

Brief Summary

The purpose of this study is to evaluate the therapeutic effect of shockwave therapy on reducing pruritus in neurodermatitis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2025

Completed
Last Updated

March 9, 2026

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

September 26, 2025

Last Update Submit

March 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 5-D Itching Scale

    The 5-D Itching Scale will be used to assess the improvement of cases by evaluating pruritus severity. Patients will complete the scale both before starting the treatment and at four sessions following the treatment. The following steps will be followed during the assessment: the patient will be positioned comfortably (sitting position), the physiotherapist will explain the pruritus symptoms score to the patient, and the patient will determine their points on the 5-D itch scale.

    one month

Study Arms (2)

Shockwave therapy + corticosteroids + emollients

EXPERIMENTAL

It will include 17 patients suffering from neurodermatitis who will receive shockwave therapy for 10min, 4 sessions, once per week and emollients \& corticosteroids for a month.

Device: Shockwave therapyDrug: Emollients & corticosteroids

Corticosteroids & Emollients

ACTIVE COMPARATOR

It will include 17 patients suffering from neurodermatitis who will receive their emollients \& corticosteroids only for a month.

Drug: Emollients & corticosteroids

Interventions

The procedures for Extracorporeal Shockwave Therapy (ESWT) involve several steps. First, the patient is positioned comfortably, and the physiotherapist explains the treatment procedure. Before the session begins, the device cables are checked for proper functioning. The shockwave type used is Non-Focused/Radial, with a treatment duration not exceeding 10 minutes. The frequency is set at 4 Hz, and the intensity ranges from 0.05 to 0.20 mJ/mm². Each session involves a total of 1000 to 2000 shocks. The treatment consists of four sessions, each held once a week.

Shockwave therapy + corticosteroids + emollients

Patients in both groups will receive emollients \& corticosteroids for one month.

Corticosteroids & EmollientsShockwave therapy + corticosteroids + emollients

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range between 55:75 years.
  • Male and female patients will participate in the study.
  • All patients have neurodermatitis.
  • All patients will be received the same approach of medication and nursing care.
  • All patients enrolled in the study will have their informed consent.

You may not qualify if:

  • Patients diagnosed with cancer.
  • Pregnant woman.
  • active infection.
  • Patients with any systemic diseases that may interfere with the objectives of the study.
  • Cardiac pacemakers or other implantable devices.
  • Current anticoagulation use.
  • Any other cause of itching

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University Hospital

Ismailia, Egypt

Location

MeSH Terms

Conditions

Neurodermatitis

Interventions

Extracorporeal Shockwave TherapyEmollientsAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationDermatologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Nessrien Afify Abd El Rashid, PhD

    Assistant Professor, Cairo University

    STUDY CHAIR
  • Noha Zakaria Tawfik, PhD

    Assistant Professor, Suez Canal University

    STUDY DIRECTOR
  • Doaa Atef Aly, PhD

    Lecturer, Cairo university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 3, 2025

Study Start

December 15, 2024

Primary Completion

September 15, 2025

Study Completion

October 25, 2025

Last Updated

March 9, 2026

Record last verified: 2025-09

Locations