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Trial Detail

CUHK_CCRB00538

2016-12-05

Prospective

Not applicable

NIL

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

NIL

Not Applicable

Ko Shaau Yiu

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

26326553

koko@cuhk.edu.hk

The Hong Kong Institute of Integrative Medicine

Hong Kong

Regina Wing Shan SIT

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

28733100

reginasit@cuhk.edu.hk

The Jockey Club School of Public Health & Primary Care

Hong Kong

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

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

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)”

ChronoA LSS Study

Hong Kong, China

Yes

2016-11-24

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.206-T

Lumbar spinal stenosis

Other

Chronoacupuncture

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.

Acupuncture

Not applicable

4 weeks

twice a week

Waitlist group

Not applicable

Not applicable

3 months

Not applicable

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

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

40

75

Both Male and Female

Interventional

Randomized

1:1 randomized clinical trial

Not Applicable

Open label

Parallel

2

2016-12-12

24

Complete

The improvement of the 6 minute walk test

6 minute walk test

3 months

Swiss Spinal Stenosis

Chinese Swiss spinal stenosis questionnaire

3 months

Roland Morris Disability Score

The Chinese Roland Morris Disability Score

3 months

Quality of Life Measurement

EuroQol5D

3 months

No

2018-11-01

ChiCTR-IOR-16010094

2016-12-05

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