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

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ClinicalTrials.gov Identifier: NCT03974438
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Sollie, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Post Herpetic Neuralgia Procedure: Superficial dry needling / Acupunture Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
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.

Primary Purpose: Treatment
Official Title: Acupuncture (Dry-needling) as Treatment of Post-herpetic Neuralgia: A Double-blinded Randomized Clinical Trial.
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Shingles

Arm Intervention/treatment
Experimental: 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.
Procedure: Superficial dry needling / Acupunture
Se arm-description.

Sham Comparator: 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.
Procedure: Superficial dry needling / Acupunture
Se arm-description.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Neuropathic pain [LEVEL OF PAIN] [ Time Frame: 1 month ]

    Neuropathic Pain Symptom inventory (NPSI), Questionnaire. NPSI consists of 12 items in total: 10 items investigates differential symptoms descriptors and 2 items evaluate spontaneous and paroxysmal spontaneous pain.

    The tool evaluates mean pain intensity in the last 24h in a verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of the 10 descriptors.

    The descriptors are:

    Burning, Squeezing, Pressure, Electric Shocks, Stabbing, Provoked by brushing. Provoked by pressure, Evoked by cold stimulation, Pins and needles, Tingling.


  2. Quality of life [QUALITY OF LIFE/ SATISFACTION] [ Time Frame: 1 month ]

    Short Form 36 (SF-36), Questionnaire. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per a scoring key. All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. After this, items in the same scale are averaged together to create the 8 scale scores.

    The eight health concepts are: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health.




Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974438


Contacts
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Contact: Jens Ahm Sorensen, Prof. PhD 65412436 ext +45 jens.sorensen@rsyd.dk
Contact: Martin Sollie, MD 42755524 ext +45 martin_sollie@hotmail.com

Locations
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Denmark
Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital

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Responsible Party: Martin Sollie, Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery Affiliation: Odense University Hospital Collaborators:, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03974438     History of Changes
Other Study ID Numbers: S-XXX1
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martin Sollie, Odense University Hospital:
post-herpetic neuralgia
pain
post herpetic neuralgia
shingles
autologous fat grafting
autologous fat transplant

Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms