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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)
2019-08-13
ChiCTR1800014906
2018-02-12
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