Impact of Acupuncture on Vasomotor Rhinitis

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

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.

Study Overview

• Status: Completed
• Conditions: Acupuncture; Vasomotor Rhinitis
• Intervention / Treatment: Device: Sham-laser acupuncture; Device: Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • Department of otorhinolaryngology of the University of Munich
  • Munich, Germany
    • Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Device: 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.
Active Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Dominik Irnich, PD. Dr., Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich, Germany

Publications and helpful links

General Publications

• Fleckenstein J, Raab C, Gleditsch J, Ostertag P, Rasp G, Stor W, Irnich D. Impact of acupuncture on vasomotor rhinitis: a randomized placebo-controlled pilot study. J Altern Complement Med. 2009 Apr;15(4):391-8. doi: 10.1089/acm.2008.0471.

Study record dates

Study Major Dates

• Study Start: January 1, 1998
• Primary Completion (Actual): January 1, 1999
• Study Completion (Actual): June 1, 1999

Study Registration Dates

• First Submitted: May 20, 2008
• First Submitted That Met QC Criteria: May 20, 2008
• First Posted (Estimate): May 22, 2008

Study Record Updates

• Last Update Posted (Estimate): January 13, 2015
• Last Update Submitted That Met QC Criteria: January 12, 2015
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: placebo; acupuncture; randomised controlled trial; sham laser; vasomotor rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis; Rhinitis, Vasomotor
• Other Study ID Numbers: MPC-UM-0001-DI