Post Herpetic NeuralgiaNCT03974438
Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial.
A study testing Superficial dry needling / Acupunture in people with Post Herpetic Neuralgia, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Post Herpetic Neuralgia
- What is being tested?
- Superficial dry needling / Acupunture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Sep 2019to 14 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- A psychiatric illness affecting participation in the study.
- Active cancer
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture (Dry-needling) as Treatment of Post-herpetic Neuralgia: A Double-blinded Randomized Clinical Trial.
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.
Read the 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).
- Conditions
- Post Herpetic Neuralgia
- Being tested
- Superficial dry needling / Acupunture
- Keywords
- post-herpetic neuralgia, pain, post herpetic neuralgia, shingles, autologous fat grafting, autologous fat transplant
- Medical subject headings
- Neuralgia, Postherpetic, Pain, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial dry needling / AcupuntureProcedure or surgery
Se arm-description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Superficial dry needling / Acupunture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start19 Sep 2019
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Herpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Sollie, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974438
- Sponsor's protocol ID
- S-20190101
- Status last verified
- Sep 2020
- First submitted
- 1 Jun 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture (Dry-needling) as Treatment of Post-herpetic Neuralgia: A Double-blinded Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03974438
- Acronym / sponsor ID
- S-20190101
- Conditions
- Post Herpetic Neuralgia
- Keywords
- post-herpetic neuralgia, pain, post herpetic neuralgia, shingles, autologous fat grafting, autologous fat transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Acupunture (SDN) | Experimental | Procedure: Superficial dry needling / AcupunturePatients 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. |
| Control - Sham acupunture | Sham comparator | Procedure: Superficial dry needling / AcupunturePatients 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- A psychiatric illness affecting participation in the study.
- Active cancer
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial dry needling / AcupuntureSe arm-description. | Procedure or surgery | Control - Sham acupunture, Intervention - Acupunture (SDN) |
Primary outcome
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.
2 secondary outcomes
Neuropathic pain [LEVEL OF PAIN]
Time frame: 1 month
Quality of life [QUALITY OF LIFE/ SATISFACTION]
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Post Herpetic Neuralgia
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Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
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The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial dry needling / Acupunture in people with Post Herpetic Neuralgia, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal pain [LEVEL OF PAIN] (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.