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

Primary Purpose

Post Herpetic Neuralgia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Superficial dry needling / Acupunture
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Herpetic Neuralgia focused on measuring post-herpetic neuralgia, pain, post herpetic neuralgia, shingles, autologous fat grafting, autologous fat transplant

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention - Acupunture (SDN)

Control - Sham acupunture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Neuropathic pain [LEVEL OF PAIN]
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.
Quality of life [QUALITY OF LIFE/ SATISFACTION]
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.

Full Information

First Posted
June 1, 2019
Last Updated
September 14, 2020
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03974438
Brief Title
Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial.
Official Title
Acupuncture (Dry-needling) as Treatment of Post-herpetic Neuralgia: A Double-blinded Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
September 14, 2020 (Actual)
Study Completion Date
September 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Herpetic Neuralgia
Keywords
post-herpetic neuralgia, pain, post herpetic neuralgia, shingles, autologous fat grafting, autologous fat transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention - Acupunture (SDN)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - Sham acupunture
Arm Type
Sham Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Superficial dry needling / Acupunture
Intervention Description
Se arm-description.
Primary Outcome Measure Information:
Title
Dermal pain [LEVEL OF PAIN]
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Neuropathic pain [LEVEL OF PAIN]
Description
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.
Time Frame
1 month
Title
Quality of life [QUALITY OF LIFE/ SATISFACTION]
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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