Impact of Acupuncture on Vasomotor Rhinitis

Study Overview
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Brief Summary
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Chronic rhinitis without an allergic or infectious aetiology (vasomotor rhinitis) is a common disease for which there are only poor therapeutic treatment options. The current placebo controlled partially double blinded pilot study evaluated the effects of acupuncture on the symptoms of vasomotor rhinitis.

Official Title
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Impact of Acupuncture on Vasomotor Rhinitis: a Randomised Placebo Controlled Pilot Study

Conditions
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Vasomotor Rhinitis, Acupuncture

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham-laser acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: term of sickness > 3 month negative allergic testing Exclusion Criteria: term of sickness < 3 month previous nasal surgeries polyposis nasi contraindications regarding acupuncture (such as: risk of bleeding, pregnancy) psychologic disorders drug addiction autoimmune disease other severe disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham-laser acupuncture<br>The sham-laser acupuncture treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). Sham-laser acupuncture was applied at the same points as the acupuncture treatment. A deactivated laser pen (Seirin, 3B Scientific GmbH, Hamburg, Germany) that could only beam normal red light rather than laser was used. The total number of acupuncture points utilized was equal to the acupuncture group. Every point was treated for 30 sec with the total treatment time of 20 minutes. | Device: Sham-laser acupuncture<br>* The sham-laser acupuncture treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). Sham-laser acupuncture was applied at the same points as the acupuncture treatment. A deactivated laser pen (Seirin, 3B Scientific GmbH, Hamburg, Germany) that could only beam normal red light rather than laser was used. The total number of acupuncture points utilized was equal to the acupuncture group. Every point was treated for 30 sec with the total treatment time of 20 minutes.<br>|
| Active Comparator: Acupuncture<br>The treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). The acupuncture treatment was semi-standardised. It consisted of a basic pool of 6 body acupuncture points. Five additional acupuncture body points together with auricular points formed an individual pool. After needle insertion, the needle was manipulated until the subject obtained the de-Qi response (a deep aching or full feeling at the needle, [22]). After obtaining the de-Qi response, there was no further manipulation of the needle. Each session lasted 20 minutes. | Device: Acupuncture<br>* The treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). The acupuncture treatment was semi-standardised. It consisted of a basic pool of 6 body acupuncture points. Five additional acupuncture body points together with auricular points formed an individual pool. After needle insertion, the needle was manipulated until the subject obtained the de-Qi response (a deep aching or full feeling at the needle, [22]). After obtaining the de-Qi response, there was no further manipulation of the needle. Each session lasted 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27). |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures were the evaluation of a subjective symptoms score by patients' diaries and of their quality of life (SF-12 health survey). |  | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, randomised controlled trial, placebo, sham laser, vasomotor rhinitis