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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682162

Locations
Germany
Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich,
Munich, Germany
Department of otorhinolaryngology of the 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
Study First Received: May 20, 2008
Last Updated: January 20, 2010
Health Authority: Germany: Ethikkommission der Medizinischen Fakultät der LMU München

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

ClinicalTrials.gov processed this record on August 26, 2014