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Impact of Acupuncture on Vasomotor Rhinitis

Primary Purpose

Vasomotor Rhinitis, Acupuncture

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Acupuncture
Sham-laser acupuncture
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasomotor Rhinitis focused on measuring acupuncture, randomised controlled trial, placebo, sham laser, vasomotor rhinitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of otorhinolaryngology of the University of Munich
  • Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich,

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham-laser acupuncture

Acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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).

Full Information

First Posted
May 20, 2008
Last Updated
January 12, 2015
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00682162
Brief Title
Impact of Acupuncture on Vasomotor Rhinitis
Official Title
Impact of Acupuncture on Vasomotor Rhinitis: a Randomised Placebo Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
January 1999 (Actual)
Study Completion Date
June 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Rhinitis, Acupuncture
Keywords
acupuncture, randomised controlled trial, placebo, sham laser, vasomotor rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham-laser acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Acupuncture
Intervention Description
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
Intervention Name(s)
Sham-laser acupuncture
Intervention Description
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 Outcome Measure Information:
Title
The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27).
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Irnich, PD. Dr.
Organizational Affiliation
Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of otorhinolaryngology of the University of Munich
City
Munich
Country
Germany
Facility Name
Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich,
City
Munich
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19388861
Citation
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.
Results Reference
result

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Impact of Acupuncture on Vasomotor Rhinitis

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