Contact information
Type
Scientific
Primary contact
Miss Denise Gibson
ORCID ID
Contact details
Physiotherapy Department
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
deniseg902@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PRF/04/3
Study information
Scientific title
A randomised controlled trial of acupuncture for the treatment of hyperventilation syndrome
Acronym
Study hypothesis
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
Southampton and Southwest Hampshire Research Ethics Committee, 03/05/2006, ref: 06/Q1704/28
Study design
Randomised controlled single-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/03/2006
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant 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
Recruitment start date
01/03/2006
Recruitment end date
31/03/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Physiotherapy Department
Southampton
SO16 6YD
United Kingdom
Funders
Funder type
Charity
Funder name
Physiotherapy Research Foundation (UK) (ref: PRF/04/3)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary