Impact of Acupuncture on Vasomotor Rhinitis

NCT ID: NCT00682162

Last Updated: 2015-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

1999-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vasomotor Rhinitis Acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type SHAM_COMPARATOR

Sham-laser acupuncture

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type 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.

Interventions

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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 Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich

Principal Investigators

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Dominik Irnich, PD. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of otorhinolaryngology of the University of Munich

Munich, , Germany

Site Status

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

Munich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 19388861 (View on PubMed)

Other Identifiers

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MPC-UM-0001-DI

Identifier Type: -

Identifier Source: org_study_id

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