A randomised controlled trial of acupuncture for the treatment of hyperventilation syndrome

ISRCTN ISRCTN71727409
DOI https://doi.org/10.1186/ISRCTN71727409
Secondary identifying numbers PRF/04/3
Submission date
29/12/2005
Registration date
03/02/2006
Last edited
10/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Denise Gibson
Scientific

Physiotherapy Department
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Email deniseg902@aol.com

Study information

Study designRandomised controlled single-blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA randomised controlled trial of acupuncture for the treatment of hyperventilation syndrome
Study objectivesContinual and subtle hyperventilation can lead to a chronic condition which has been termed hyperventilation syndrome. Patients with hyperventilation syndrome are known to breathe at lower levels of arterial carbon dioxide and only small changes in this level can produce symptoms that can mimic serious disease e.g. chest pain, breathlessness, headaches, paraesthesia.

The aim of this study is to evaluate whether the use of acupuncture complements conventional physiotherapy treatment for hyperventilation syndrome. It is hypothesised that acupuncture, as an adjunct to conventional treatment for hyperventilation syndrome, will be beneficial, in terms of reducing anxiety and symptoms of hyperventilation.

Please note that, as of 14/10/2008, the anticipated end date of this trial has been extended from 31/12/2006 to 31/03/2009. The extension is due to delays in recruitment.
Ethics approval(s)Southampton and Southwest Hampshire Research Ethics Committee, 03/05/2006, ref: 06/Q1704/28
Health condition(s) or problem(s) studiedHyperventilation syndrome
InterventionCurrent interventions as of 14/10/2008:
Physiotherapy in the form of breathing retraining:
Participants will be taught relaxed diaphragmatic breathing and encouraged to reduce their breath rate to 6 - 8 breaths per minute. They will also be taught a contact-relaxation technique. They will then be advised to carry out these techniques at home at least 3 times per day.

Acupuncture:
A western approach to acupuncture therapy will be used. Participants will receive either real acupuncture or placebo acupuncture using the Streitberger needle. Needles will be placed on 8 points of the body and a draining technique will be used i.e. once inserted, the needles will be left for a period of 30 minutes. Each participant in the acupuncture group will receive twice weekly treatments for 4 weeks (therefore 8 acupuncture treatments in total).

Previous interventions:
Physiotherapy in the form of breathing retraining:
Participants will be taught relaxed diaphragmatic breathing and encouraged to reduce their breath rate to 6 - 8 breaths per minute. They will also be taught a contact-relaxation technique. They will then be advised to carry out these techniques at home daily.

Acupuncture:
A western approach to acupuncture therapy will be used. Participants will receive either real acupuncture or placebo acupuncture using the Streitberger needle. Needles will be placed on 8 points of the body and a draining technique will be used i.e. once inserted, the needles will be left for a period of 30 minutes.
Intervention typeOther
Primary outcome measureHospital Anxiety and Depression scale. This is a validated questionnaire which is used to identify anxiety and depression in non-psychiatric hospital clinics.

Added as of 14/10/2008:
All primary and secondary outcomes are measured at 1) baseline 2) pre-treatment (after a 4-week wait period to ensure participant's condition is stable) and 3) post-treatment on the 9th session.
Secondary outcome measures1. Nijmegen Questionnaire - this is a validated screening tool which has been shown to have 95% effectiveness in discriminating hyperventilators from normals
2. Measure Yourself Medical Outcome Profile (MYMOP2) - this is a validated quality of life measure, which is individualised and problem specific and also includes general wellbeing
3. Objective measures of cardiorespiratory performance will also be taken e.g. respiratory rate and pattern, resting end tidal carbon dioxide, pulse oximetry, pulse rate and blood pressure
4. Borkovec and Nau credibility rating - this will be used to assess the success of blinding

Added as of 14/10/2008:
All primary and secondary outcomes are measured at 1) baseline 2) pre-treatment (after a 4-week wait period to ensure participant's condition is stable) and 3) post-treatment on the 9th session.
Overall study start date01/03/2006
Completion date31/03/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants90
Key inclusion criteriaAny patient newly diagnosed with hyperventilation syndrome by the respiratory physicians at Southampton General Hospital.

Added as of 14/10/2008:
Both males and females, over 18 years old
Key exclusion criteria1. Any person for whom acupuncture would be contraindicated e.g. in pregnancy, pacemaker wearers
2. Any person who is receiving conventional or alternative treatment for the condition
3. People who are allergic to sticking plaster
4. People who are unable to attend for the required treatment sessions
Date of first enrolment01/03/2006
Date of final enrolment31/03/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Physiotherapy Department
Southampton
SO16 6YD
United Kingdom

Sponsor information

Physiotherapy Research Foundation (UK)
Charity

14 Bedford Row
London
WC1R 4ED
United Kingdom

ROR logo "ROR" https://ror.org/04sn78z72

Funders

Funder type

Charity

Physiotherapy Research Foundation (UK) (ref: PRF/04/3)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

10/05/2016: No publications found, verifying study status with principal investigator.