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OpenTrials
Completed

NCT Number: NCT00682162

Impact of Acupuncture on Vasomotor Rhinitis

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of otorhinolaryngology of the University of Munich, Munich, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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).

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
1999
Study completion
1999
First posted
May 22, 2008
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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