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

ISRCTN	ISRCTN71727409
DOI	https://doi.org/10.1186/ISRCTN71727409
Protocol serial number	PRF/04/3
Sponsor	Physiotherapy Research Foundation (UK)
Funder	Physiotherapy Research Foundation (UK) (ref: 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

Primary study design	Interventional
Study design	Randomised controlled single-blind trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of acupuncture for the treatment of hyperventilation syndrome
Study objectives	Continual 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) studied	Hyperventilation syndrome
Intervention	Current 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 type	Other
Primary outcome measure(s)	Hospital 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.
Key secondary outcome measure(s)	1. 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.
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	90
Key inclusion criteria	Any 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 criteria	1. 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 enrolment	01/03/2006
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Physiotherapy Department

Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

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