Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00422

2 Trial Registration Date

2014-07-11

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.627-T

4 Source(s) of Funding

Pok Oi Hospital - The Chinese University of Hong Kong Chinese Medicine Centre for Training and Research (Shatin)

5 Primary Sponsor

School of Chinese Medicine, The Chinese University of Hong Kong

6 Secondary Sponsor

Pok Oi Hospital - The Chinese University of Hong Kong Chinese Medicine Centre for Training and Research (Shatin)

Function

Please specify

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

i Name

Professor Yuanqi GUO

ii Address

School of Chinese Medicine, 1/F Sino Building, The Chinese University of Hong Kong, N.T., Hong Kong

iii Phone

(852) 3943 8131 / (852) 2479 2126

iv Email

cuguoyq@yahoo.com.hk

v Affiliation

School of Chinese Medicine, The Chinese University of Hong Kong

vi Country

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

i Name

Professor Yuanqi GUO

ii Address

School of Chinese Medicine, 1/F Sino Building, The Chinese University of Hong Kong, N.T., Hong Kong

iii Phone

(852) 3943 8131 / (852) 2479 2126

iv Email

cuguoyq@yahoo.com.hk

v Affiliation

School of Chinese Medicine, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Efficacy of Abdominal Acupuncture for Neck Pain: A Randomized Controlled Trial

10 Public Title

Efficacy of Abdominal Acupuncture for Neck Pain: A Randomized Controlled Trial

i Public Title in Chinese 研究名稱

腹針治療頸痛的臨床隨機對照研究

11 Short Title (Optional)

Clinical Study of Abdominal Acupuncture for Neck Pain

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?

2014-01-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Neck pain

15 Intervention

i Types of intervention

Other

Please specify

Abdominal Acupuncture

ii Description/ name of Intervention/article

Abdominal acupuncture treatment under the guidance of traditional Chinese medicine acupuncture meridian theory and new concepts developed by Dr Ziyun Bo

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Three times a week for two weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Sham abdominal acupuncture treatment

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

* Between 18 and 65 years of age with the ability to speak and understand Cantonese;
* Neck complaints on: (i) pain, stiffness or tenderness, with or without musculoskeletal signs including decreased range of motion and point tenderness; (ii) pain felt in the neck with radiation to the occiput or towards the shoulders, or both with limitation of neck motion; and (iii) neck pain with degenerative joint disease or cervical spondylosis, or both;
* 3 points or more on a 10-cm visual analogue scale for neck pain at the time of screening;
* No previous treatment with abdominal acupuncture for any reason;
* Agreed to be randomized; and
* Agreed to sign the informed consent form

ii Exclusion Criteria

* Visceral pain in the neck, including carcinoma of thyroid or larynx and tuberculosis of larynx;
* Serious spinal disorders, including malignancy, vertebral fracture, spinal infection and inflammatory spondylitis;
* Patients who previously had neck surgery or are scheduled to have one during the study;
* Other chronic diseases that could interfere with abdominal acupuncture treatment effects, including cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalgia, rheumatoid arthritis, dementia and epilepsy;
* Diagnosis of cancer of any nature;
* Chief musculoskeletal pain other than neck pain;
* Conditions that abdominal acupuncture might not be safe, including clotting disorders, administration of an anticoagulant agent, acute abdominal disorders, venous dilation of the naval, celiac tumor and pregnant women;
* Possess abdominal scar which will affect the proper selection of acupuncture points for abdominal acupuncture;
* Severe psychiatric or psychological disorder;
* Acupuncture treatment for neck pain during the previous month;
* Conflicting or ongoing co-interventions (drugs or alternative treatments, or both);
* Engage in any other clinical trial during the study period;
* Pending neck-related litigation or disability claims;
* Incapacity to complete the questionnaires or to answer the questions of the assessor in the study; and
* Pregnant and breast feeding women

iii Age Minimum

18 years old

iv Age Maximum

65 years old

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-09-01

21 Target Sample Size

154

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Northwick Park Neck Pain Questionnaire

24 Secondary Outcome

* VAS for pain intensity
* SF-36-v2 Health Survey
* Credibility test
* Satisfaction with treatment
* Blinding assessment

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-08-29

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004932

28 Date of Registration in Primary Registry

2014-07-11

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-07-16