Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superficial dry needling / Acupunture | Procedure | Se arm-description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | Funen | 5000 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D010146 | Pain |
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
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.
Not provided
Not provided
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.
| 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. | 1 month |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |