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

NCT03974438 | Completed

• 1 other identifier: S-20190101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Herpetic Neuralgia

Keywords

post-herpetic neuralgia; pain; post herpetic neuralgia; shingles; autologous fat grafting; autologous fat transplant

Outcome Measures

Primary Outcomes (1)

• Dermal pain [LEVEL OF PAIN]

  Questionnaire. Visual Analogue Scale (VAS). Patients will be asked to report on their average and maximum level of pain on a scale from 0-10.

  1 month

Secondary Outcomes (2)

• Neuropathic pain [LEVEL OF PAIN]

  1 month

• Quality of life [QUALITY OF LIFE/ SATISFACTION]

  1 month

Study Arms (2)

Intervention - Acupunture (SDN)

EXPERIMENTAL

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.

Procedure: Superficial dry needling / Acupunture

Control - Sham acupunture

SHAM COMPARATOR

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.

Procedure: Superficial dry needling / Acupunture

Interventions

Superficial dry needling / Acupunture PROCEDURE

Se arm-description.

Control - Sham acupunture; Intervention - Acupunture (SDN)

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• A psychiatric illness affecting participation in the study.
• Active cancer
• Pregnancy

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Pain; Herpes Zoster

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery Affiliation: Odense University Hospital Collaborators:

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 5, 2019
• Study Start: September 19, 2019
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)