Condition category
Nervous System Diseases
Date applied
09/03/2014
Date assigned
04/04/2014
Last edited
04/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study aims to find out about the effects of a traditional Chinese therapeutic massage called tuina on patients with a sleep disorder called obstructive sleep apnea/hypopnea syndrome (OSAHS).

Who can participate?
OSAHS patients who did not want to have usual treatment or surgery were recruited.

What does the study involve?
Patients were randomly allocated to receive tuina massage or no treatment. Patients received tuina in various sessions spread over 10 weeks. Quality of life, snoring and sleepiness in daytime were recorded before and 3 months after the treatment.

What are the possible benefits and risks of participating?
Symptoms/signs of OSAHS may get better after treatment. The patients were also informed about the possible side effects of the massage, such as deep venous thrombosis, burns, skin infections, eczema, open wounds, bone fractures, and advanced osteoporosis. In addition, the patients were told about rare serious side effects, such as bone fractures and liver rupture, and minor adverse effects, such as significant pain or discomfort during or shortly after treatment .

Where is the study run from?
We performed this study at the outpatient clinic of acupuncture and sleep center of Chang Gung Memorial Hospital (CGMH) – Kaohsiung Medical Center, Taiwan.

When is the study starting and how long is it expected to run for?
This study ran between January 2010 and January 2011.

Who is funding the study?
The Chang Gung Memorial Hospital (Taiwan).

Who is the main contact?
Dr Cheng-Nan Lu (lu43364430@gmail.com)
Dr Hsin-Ching Lin

Trial website

Contact information

Type

Scientific

Primary contact

Dr cheng-nan lu

ORCID ID

Contact details

Kaohsiung Chang Gung Memorial Hospital
123
Ta-Pei Rd.
Niao-Sung District
Kaohsiung City
833
Taiwan
Kaohsiung
83311
Taiwan
+886-7-7317123 ext.2334
lu43364430@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effects of tuina on patients with obstructive sleep apnea/hypopnea syndrome: a one-year single-blind randomised trial

Acronym

Study hypothesis

To study the effects of tuina (traditional Chinese therapeutic massage) on patients with obstructive sleep apnea/hypopnea syndrome (OSAHS).

Ethics approval

Institutional Review Board of Chang Gung Memorial Hospital for Biomedical Research, IRB#98-1059B

Study design

One-year single-blind randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obstructive Sleep Apnea/Hypopnea Syndrome

Intervention

Patients were randomised to receive either tuina treatment or no treatment.

The patients received tuina treatment two times per week for 10 weeks. When we used tuina for treatment, the definite course of action was to first use the rolling, pressing and kneading methods on the median line of the neck on the GV16, GV15 and GV14 and both sides of GB20 down to BL11, with back-and-forth manipulation for 3 minutes. GV15, CV23, external Jinjin, Yuye and TH17 on the posterior neck and chin were pressed for 20 seconds. Rolling/kneading and pushing manipulation with one finger were used on the back part of the bladder meridian and governor vessel for 3 minutes. CV12, CV6 and CV3 were pressed for 20 seconds, then the abdomen vibrating method was used for 5 minutes. Treatment time was approximately 15 minutes per session, two times a week for 10 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Polysomnography (PSG)
2. Neck circumference (NC, cm)
3. Body mass index (BMI, body weight/height2=kg/m2)

The subjective and objective outcome measures were checked pretreatment (baseline) and 3 months after treatment.

Secondary outcome measures

1. Medical outcomes study 36-item Short-Form Health Survey (SF-36)
2. Snoring intensity was evaluated by a ten-point visual analog scale
3. Epworth Sleepiness Scale (ESS)

The subjective and objective outcome measures were checked pretreatment (baseline) and 3 months after treatment.

Overall trial start date

01/01/2010

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. OSAHS patients who refused conservative therapies or surgery recruited from the outpatient clinic of the sleep center of Chang Gung Memorial Hospital (CGMH) – Kaohsiung Medical Center
2. OSAHS confirmed by a full polysomnographic study

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. High alcohol intake (> 80 g/day)
2. Morbid obesity
3. Significant lung disease
4. Neurological disease
5. Intellectual deficits
6. Skeletal facial framework problems
7. Central apnea
8. Using of any hypnotic drugs or previous oropharyngeal surgery

Recruitment start date

01/01/2010

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Taiwan

Trial participating centre

Kaohsiung Chang Gung Memorial Hospital , 123, Ta-Pei Rd., Niao-Sung District, Kaohsiung City, 833, Taiwan
Kaohsiung
83311
Taiwan

Sponsor information

Organisation

Kaohsiung Chang Gung Memorial Hospital (Taiwan)

Sponsor details

Kaohsiung Chang Gung Memorial Hospital
123 Ta-Pei Road
Niao-Sung District
Kaohsiung
83311
Taiwan
+886 (0) 7 7317123 ext. 2533
enthclin@aol.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Kaohsiung Chang Gung Memorial Hospital (Taiwan) (grant CMRPG 890341)

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