Acupuncture (Dry-needling) as Treatment of Post-herpetic Neuralgia: A Double-blinded Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Odense University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Dermal pain [LEVEL OF PAIN]
Study Overview
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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Superficial dry needling / Acupunture (Procedure)
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.
Intervention: Superficial dry needling / Acupunture (Procedure)
Outcomes
Primary Outcomes
Dermal pain [LEVEL OF PAIN]
Time Frame: 1 month
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.
Secondary Outcomes
- Neuropathic pain [LEVEL OF PAIN](1 month)
- Quality of life [QUALITY OF LIFE/ SATISFACTION](1 month)
Investigators
Martin Sollie
Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery Affiliation: Odense University Hospital Collaborators:
Odense University Hospital