Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00327

2 Trial Registration Date

2012-07-26

i Registration Status

Prospective

3 Secondary IDs

ICM/CTS/12/351

4 Source(s) of Funding

Institute of Chinese Medicine, CUHK

5 Primary Sponsor

Department of Obstetrics & Gynaecology, CUHK

6 Secondary Sponsor

Institute of Chinese Medicine, CUHK

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Prof. Ronald Wang

ii Address

1st Floor, Block E, Department of Obstetrics & Gynaecology, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

iii Phone

2632 3099

iv Email

ccwang@cuhk.edu.hk

v Affiliation

Department of Obstetrics & Gynaecology, CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Leung Ping Chung

ii Address

5/F, Institute of Chinese medicine, School of Public Health Building, Prince of Wales Hospital, Shatin

iii Phone

2252 8863

iv Email

pingcleung@cuhk.edu.hk

v Affiliation

Institute of Chinese Medicine, CUHK

vi Country

9 Official Scientific Title of the Study

Acupuncture for pelvic/low back pain during pregnancy

10 Public Title

Acupuncture for pelvic/low back pain during pregnancy

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Acupuncture for pelvic/low back pain during pregnancy

12 Countries of Recruitment

HONG KONG

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-07-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Pelvic and low back pain among pregnant women

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Acupuncture

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Minimum: 1 Course, twice a week for 4 weeks
Maximum: 2 courses priors to give birth

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Non-randomized controlled Trial.
Acupuncture vs. gestational-age matched control with no intervention

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

•Pregnant for 16 to 34 weeks, suffering from pelvic/low-back pain VAS >= 4/10
•Single foetus with no abnormality
•Healthy without serious medical condition
•Capable of filling up self-report
•Consent for the trial

ii Exclusion Criteria

•Back pain before pregnancy
•Preexisting rheumatological conditions
•Sciatica
•Psychiatric problems
•Those maintained on analgesic medication
•other pain conditions, systemic disorders, coagulation disturbances, and infection risk

iii Age Minimum

18

iv Age Maximum

50

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-07-30

21 Target Sample Size

80

22 Recruitment Status

Unknown

23 Primary Outcome

Pain in VAS, daily after intervention and prior to labour.
Oswestry disability score, weekly after intervention and prior to labour.

24 Secondary Outcome

Adverse effects; daily
Self-medication, sick leave, medical visits; perinatal and maternal morbidity

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-08-27

27 Primary Registry and Trial Identifying Number

ChiCTR-TNC-12002390

28 Date of Registration in Primary Registry

2012-08-05

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2015-05-09