Condition category
Signs and Symptoms
Date applied
29/12/2005
Date assigned
03/02/2006
Last edited
10/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Physiotherapy Research Foundation (UK)

Sponsor details

14 Bedford Row
London
WC1R 4ED
United Kingdom

Sponsor type

Charity

Website

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

Publication citations

Additional files

Editorial Notes

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