Impact of Acupuncture on Vasomotor Rhinitis

This study has been completed.
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00682162
First received: May 20, 2008
Last updated: January 20, 2010
Last verified: May 2008

May 20, 2008
January 20, 2010
January 1998
January 1999   (final data collection date for primary outcome measure)
The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27). [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00682162 on ClinicalTrials.gov Archive Site
Secondary outcome measures were the evaluation of a subjective symptoms score by patients' diaries and of their quality of life (SF-12 health survey). [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Vasomotor Rhinitis
  • Acupuncture
  • 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.
  • 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.
  • 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.
    Intervention: Device: Sham-laser acupuncture
  • 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.
    Intervention: Device: Acupuncture
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 1999
January 1999   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00682162
MPC-UM-0001-DI
No
PD Dr. Dominik Irnich, Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich
Ludwig-Maximilians - University of Munich
Not Provided
Principal Investigator: Dominik Irnich, PD. Dr. Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich, Germany
Ludwig-Maximilians - University of Munich
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP