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Trial Detail

CUHK_CCRB00586

2018-02-12

Prospective

CREC Ref. No. 2017.600-T

Chinese Medicine Department, Hospital Authority, Hong Kong SAR

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

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

Form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group

HO Lai Fun

G/F, Shatin (Taiwai) Clinic, 2 Man Lai Road, Taiwai, Shatin, NT., Hong Kong SAR

(852) 24792126

cmpst@pokoi.org.hk

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

Hong Kong SAR, China

LIN Zhixiu

4L, Integrative Medical Centre, 4/F, Day Treatment Block, Prince of Wales Hospital, Hong Kong

(852) 28733252

linzx@cuhk.edu.hk

Hong Kong Institute of Integrative Medicine

Hong Kong SAR, China

Electro-acupuncture plus warm needling therapy for heel pain: a randomized controlled trial

Electro-acupuncture plus warm needling therapy for heel pain

電針配合溫針灸治療跟痛症的隨機對照臨床研究

EAWN Heel Pain

Hong Kong SAR, China

Yes

2018-01-27

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC Ref. No. 2017.600-T

Heel pain

Other

Electro-acupuncture plus warm needling therapy

Electro-acupuncture and warm needling therapy (acupuncture and moxibustion) used in this study are based on traditional Chinese medicine theory and review of literature.

Not applicable

Not applicable

Four weeks

Six treatment sessions over a 4-week period on a regular basis

Waitlist control (no treatment)

Not applicable

Not applicable

Four weeks

No treatment

- males and females aged 50 to 80 years;

- heel pain characterized by the pain worsened when standing or walking after getting up in the morning. The pain gets relieved after a while of walking, and worsened after a long period of walking;

- heel pain with marked tenderness at the plantar aspect and lateral aspect of the calcaneal tuberosity;

- either unilateral or bilateral heel pain;

- acute or chronic pain in nature with degree of heel pain experienced upon taking the first few steps rating 50 mm or more on a 0-100 mm visual analogue scale at the time of recruitment; and

- agreed to sign the informed consent form.

- suffering from pain in another area that is severe than heel pain;

- loss of plantar foot sensation;

- open wounds or tumors, skin ulceration on the painful heel(s) and surrounding area;

- documentation of fracture or abnormalities at the painful heel(s) within 4 weeks that are not suitable for the study treatments;

- acupuncture and/ or moxibustion treatment for the same heel pain during the previous month;

- expected ongoing co-interventions (medication or alternative treatments, or both) during study period;

- previous surgery to the painful heel(s) or scheduled to have one during the study period;

- severe needle phobia;

- known hypersensitive reaction after acupuncture and moxibustion treatment or an inability to cooperate with the acupuncture and moxibustion procedure;

- diagnosis of cancer of any nature within 5 years;

- known severe disease of the heart, brain, lung, liver, kidney, or hematopoietic system;

- currently on cardiac pacemaker;

- pregnant, breast feeding or expecting a pregnancy during the study period;

- known severe psychiatric or psychological disorder;

- other factors that have been deemed unsuitable for participation assessed by investigators;

- engage in any other clinical trial during the study period;

- pending foot-related litigation or disability claims; and

- incapable to understand and answer the questions of the assessors in the study.

50 years old

80 years old

Both Male and Female

Interventional

Randomized

Random allocation is performed by a computer software

Not Applicable

Open label

Parallel

Other

Not Applicable

2018-05-01

80

Complete

First-step pain VAS

Questionnaire

4-week (end of treatment)

First-step pain VAS

Questionnaire

2-week, 8-week (for intervention group)

Foot Function Index

Questionnaire

2-week, 4-week (end of treatment), 8-week (for intervention group)

Global rating of change (GRC) scale

Questionnaire

4-week (end of treatment)

No

2019-08-13

ChiCTR1800014906

2018-02-12

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