Impact of Acupuncture on Vasomotor Rhinitis

Acupuncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682162
• Other study ID #: MPC-UM-0001-DI
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2008
• Last updated: January 12, 2015
• Start date: January 1998
• Est. completion date: June 1999

Study information

• Verified date: May 2008
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethikkommission der Medizinischen Fakultät der LMU München
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 1999
• Est. primary completion date: January 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acupuncture
• Rhinitis
• Rhinitis, Vasomotor
• Vasomotor Rhinitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Department of otorhinolaryngology of the University of Munich	Munich
Germany	Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich,	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Fleckenstein J, Raab C, Gleditsch J, Ostertag P, Rasp G, Stör 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27).		5 weeks	No
Secondary	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	No