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Impact of Acupuncture on Vasomotor Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00682162
First Posted: May 22, 2008
Last Update Posted: January 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ludwig-Maximilians - University of Munich
  Purpose
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.

Condition Intervention Phase
Vasomotor Rhinitis Acupuncture Device: Acupuncture Device: Sham-laser acupuncture Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Impact of Acupuncture on Vasomotor Rhinitis: a Randomised Placebo Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27). [ Time Frame: 5 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: January 1998
Study Completion Date: June 1999
Primary Completion Date: January 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682162


Locations
Germany
Department of otorhinolaryngology of the University of Munich
Munich, Germany
Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich,
Munich, Germany
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Dominik Irnich, PD. Dr. Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich, Germany
  More Information

Publications:
Responsible Party: PD Dr. Dominik Irnich, Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich
ClinicalTrials.gov Identifier: NCT00682162     History of Changes
Other Study ID Numbers: MPC-UM-0001-DI
First Submitted: May 20, 2008
First Posted: May 22, 2008
Last Update Posted: January 13, 2015
Last Verified: May 2008

Keywords provided by Ludwig-Maximilians - University of Munich:
acupuncture
randomised controlled trial
placebo
sham laser
vasomotor rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases