Notalgia ParestheticaNCT06508073
Neural Therapy in Notalgia Paresthetica
An observational study of Notalgia Paresthetica, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Notalgia Paresthetica
- What is being tested?
- Neural Therapy
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2024to 10 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 30-60 years old patients with Notalgia Paresthetica
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
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
- Being tested
- Neural Therapy
- Keywords
- back pain, intralesional injection, neuralgia, pruritus
- Medical subject headings
- Back Pain, Neuralgia, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural TherapyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale for Pain
A scale between 0 and 10 was used to question the pain level.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start26 Jun 2024
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Notalgia ParestheticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508073
- Sponsor's protocol ID
- 4446
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Therapy in Notalgia Paresthetica
- ClinicalTrials.gov ID
- NCT06508073
- Acronym / sponsor ID
- 4446
- Conditions
- Notalgia Paresthetica
- Keywords
- back pain, intralesional injection, neuralgia, pruritus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 30-60 years old patients with Notalgia Paresthetica
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural TherapyThe 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. | Other | – |
Primary outcome
Numeric Rating Scale for Pain
Time frame: 12 weeks after treatment
A scale between 0 and 10 was used to question the pain level.
PainDETECT Questionnaire for assessing Neuropathic pain
Time frame: 12 weeks after treatment
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.
Short Form-12 for Quality of life
Time frame: 12 weeks after treatment
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.
5-D Itch Scale
Time frame: 12 weeks after treatment
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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Recruiting
High-power Laser Therapy for Notalgia Paresthetica.
Notalgia Paresthetica
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Notalgia Paresthetica, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale for Pain (time frame: 12 weeks after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.