Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial.

NCT ID: NCT03974438

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-19

Study Completion Date

2020-09-14

Brief Summary

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The aim of this study is to perform the first RCT investigating the possible effect of superficial dry-needling (SDN) - a special kind of acupuncture used for PHN. The participants will be divided into two groups. Group A, the intervention group will receive SDN in the area of pain. Group B, the control group will receive a sham procedure.

Detailed Description

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The aim of this study is to investigate the possible effect of SDN on PHN. The study population consists of patients with chronic pain after herpes zoster.

The study is a controlled double-blinded randomized study. The participants will be divided into two groups, group A, the intervention group, will receive SDN in the area of pain. Group B, the control group will receive a sham procedure. The procedure will take place at the out-patient clinic at Odense University Hospital. The plan is to include 40 patients (20 in each group).

Conditions

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Post Herpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants will be divided into two groups, group A, the intervention group, will receive SDN in the area of pain. Group B, the control group will receive a sham procedure.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants will not be aware of the treatment given. The randomization will take place right before the procedure begins. The treatment will be given to the skin covering the spine and the patients will be placed in the supine position. They will therefore not know whether or not they are receiving the actual acupuncture or the sham procedure.

The investigator will not be present at the procedures and will not have access to patients records and data until after the trial is complete.

The outcomes are measured using validated questionnaires. They will be assessed by the investigator at the time of project completion.

Study Groups

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Intervention - Acupunture (SDN)

Patients allocated to the intervention arm will receive SDN to the area of skin over the spine on the level of the specific dermatome involved in their chronic pain.

Group Type EXPERIMENTAL

Superficial dry needling / Acupunture

Intervention Type PROCEDURE

Se arm-description.

Control - Sham acupunture

Patients allocated to the control arm will receive sham-SDN to the area of skin over the spine on the level of the specific dermatome involved in their chronic pain. The sham procedure consists of a blunted needle, that does not penetrate the skin.

Group Type SHAM_COMPARATOR

Superficial dry needling / Acupunture

Intervention Type PROCEDURE

Se arm-description.

Interventions

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Superficial dry needling / Acupunture

Se arm-description.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 50-75 years.
* Pain in the dermatomal area of the previous outbreak of HZ.
* Pain located to a dermatome originating from the thoracic or lumbar spine.
* At least six months since the outbreak.
* Understands the purpose of the study and is able to give consent.

Exclusion Criteria

* A psychiatric illness affecting participation in the study.
* Active cancer
* Pregnancy
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martin Sollie

Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery Affiliation: Odense University Hospital Collaborators:

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense University Hospital

Odense, Funen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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S-20190101

Identifier Type: -

Identifier Source: org_study_id

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