Impact of Acupuncture on Vasomotor Rhinitis

NCT00682162 | Completed Phase 3

• 1 other identifier: MPC-UM-0001-DI
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Vasomotor Rhinitis; Acupuncture

Keywords

acupuncture; randomised controlled trial; placebo; sham laser; vasomotor rhinitis

Outcome Measures

Primary Outcomes (1)

• The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27).

  5 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Sham-laser acupuncture

SHAM COMPARATOR

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

Acupuncture

ACTIVE COMPARATOR

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

Interventions

Acupuncture DEVICE

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.

Acupuncture

Sham-laser acupuncture DEVICE

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.

Sham-laser acupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• term of sickness \> 3 month
• negative allergic testing

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (2)

Department of otorhinolaryngology of the University of Munich

Munich, Germany

Location

Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich,

Munich, Germany

Location

Related Publications (1)

• 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.

  PMID: 19388861 RESULT

MeSH Terms

Conditions

Rhinitis, Vasomotor

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Dominik Irnich, PD. Dr.

  Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: January 1, 1998
• Primary Completion: January 1, 1999
• Study Completion: June 1, 1999
• Last Updated: January 13, 2015

Record last verified: 2008-05

Locations

DE (2)