Impact of Acupuncture on Vasomotor Rhinitis

Phase 3

Completed

• Conditions: Vasomotor Rhinitis; Acupuncture
• Interventions: Device: Sham-laser acupuncture; Device: Acupuncture

• Registration Number: NCT00682162
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-01
• Primary Completion: 1999-01
• Study Completion: 1999-06
• Status Verified: 2008-05
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-22
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham-laser acupuncture	Sham-laser acupuncture	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.
Acupuncture	Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27).	5 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Department of otorhinolaryngology of the University of Munich; 🇩🇪 Munich, Germany

Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich,; 🇩🇪 Munich, Germany