Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00538

2 Trial Registration Date

2016-12-05

i Registration Status

Prospective

3 Secondary IDs

Not applicable

4 Source(s) of Funding

NIL

5 Primary Sponsor

The Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong

6 Secondary Sponsor

NIL

Function

Not Applicable

Please specify

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

i Name

Ko Shaau Yiu

ii Address

4L, 4/F, Day Treatment Block, Prince of Wales Hospital, Shatin, N.T.

iii Phone

26326553

iv Email

koko@cuhk.edu.hk

v Affiliation

The Hong Kong Institute of Integrative Medicine

vi Country

Hong Kong

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

i Name

Regina Wing Shan SIT

ii Address

4L, 4/F, Day Treatment Block, Prince of Wales Hospital, Shatin, N.T.

iii Phone

28733100

iv Email

reginasit@cuhk.edu.hk

v Affiliation

The Jockey Club School of Public Health & Primary Care

vi Country

Hong Kong

9 Official Scientific Title of the Study

A pilot study – Feasibility, acceptability and preliminary effectiveness of chronoacupuncture for lumbar spinal stenosis: a pragmatic randomized clinical trial (ChronoA LSS Study)”

10 Public Title

A pilot study – Feasibility, acceptability and preliminary effectiveness of chronoacupuncture for lumbar spinal stenosis: a pragmatic randomized clinical trial (ChronoA LSS Study)”

i Public Title in Chinese 研究名稱

先導計劃 - 研究按時辰針灸治療腰椎管狹窄症的可行性、接受性及初步有效性- 務實的隨機臨床試驗 (ChronoA LSS Study)”

11 Short Title (Optional)

ChronoA LSS Study

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-11-24

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.206-T

14 Medical Condition Being Studied

Lumbar spinal stenosis

15 Intervention

i Types of intervention

Other

Please specify

Chronoacupuncture

ii Description/ name of Intervention/article

Chronoacupuncture involves stimulating specific key acupoints based on the theory of “Heavenly Stems and Earthly Branches” . It is a classic mode of acupuncture that can achieve human body harmonization by choosing specific acupoints by a precisely calculated period of time rather than syndrome differentiation. There are two types of Chronoacupuncture in clinical practice, one is Twelve Channels Chronoacupuncture also called ziwuliuzhu (子午流注) and the other is Eight Extra Channels Chronoacupuncture also called Ling Gui Ba Fa (靈龜八法) and both of which are calculating effective acupoints at particular moment so as to regulate twelve channels system and eight extra channels system respectively.

iii Dosage form of the intervention

Acupuncture

iv Dosage of the intervention

Not applicable

v Duration of the intervention

4 weeks

vi Frequency of the intervention

twice a week

16 Comparative Treatments

i Description/ name of comparative treatments

Waitlist group

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

3 months

v Frequency of the comparative treatments

Not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Aged over 40

Pain or bothersomeness of lower back or leg began at least three months ago (with at least 40 of pain or bothersomeness visual analogue intensity at the time of recruitment; 0 refers to no pain or bothersomeness and 100 to worst pain or bothersomeness imaginable)

Clinical features of lumbar spinal stenosis, including neurological claudication or postural symptom changes

Lumbar spinal stenosis confirmed by radiologic examination (e.g., computed tomography or magnetic resonance imaging) within the last two years.

Willingness to participate in the study

ii Exclusion Criteria

Congenital spinal stenosis

Other spinal deformities, including spinal fractures and infections

Participants who have received spinal surgeries, such as laminectomy, spinal fusion, and discectomy, due to lumbar spinal stenosis or other spinal diseases

Other surgeries which might influence clinical features of lumbar spinal stenosis (e.g., total hip/knee replacements)

Comorbid conditions which might interfere with the participant's active participation in the study

Past/present history of malignancy

Begin a new intervention for the management of lumbar spinal stenosis within the last one month

Cauda equine syndrome (progressive lower extremity muscle weakness, loss of bowel/bladder control, and/or perianal numbness) and other urgent conditions which require immediate surgery

Subjects has pregnancy or plan to be pregnant

iii Age Minimum

40

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

1:1 randomized clinical trial

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-12-12

21 Target Sample Size

24

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

The improvement of the 6 minute walk test

ii The metric or method of measurement used

6 minute walk test

iii The timepoint(s) of primary interest

3 months

24 Secondary Outcome

i The Name of the outcome

Swiss Spinal Stenosis

ii The metric or method of measurement used

Chinese Swiss spinal stenosis questionnaire

iii The timepoint(s) of primary interest

3 months

Secondary Outcome

i The Name of the outcome

Roland Morris Disability Score

ii The metric or method of measurement used

The Chinese Roland Morris Disability Score

iii The timepoint(s) of primary interest

3 months

Secondary Outcome

i The Name of the outcome

Quality of Life Measurement

ii The metric or method of measurement used

EuroQol5D

iii The timepoint(s) of primary interest

3 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-11-01

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-16010094

28 Date of Registration in Primary Registry

2016-12-05

Back History

Trial Detail