Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs 3 times higher than general population. Conventional approaches for AS have their limitation. Previous studies demonstrated acupuncture has significant therapeutic effects for AS in diminishing joint pain, enhancing functional disorders and modifying spinal deformity. Although acupuncture is effective in relieving pain in AS patients, the evidence is very limited due to methodological flaws. Design This study will be a single-arm pilot study in patients with AS. Eligible subjects will receive electroacupuncture treatment twice per week for at least 6 weeks (12 sessions in total). The length of treatment can be extended to a maximum of 10 weeks (20 sessions in total) if participants request a prolonged treatment. The acupuncturist, who is a registered Chinese medicine practitioner, of this trial will not participate in data collection and data entry. Objective: To explore the treatment effect of electroacupuncture for relieving pain in ankylosing spondylitis. Setting: Hong Kong Participants: 20 subjects with a diagnosis of ankylosing spondylitis Main Measures: Pain Severity Numerical Rating Scale (NRS), Adverse events Data analysis All data will be double-entered and checked for consistency before conducting the analysis. Binomial test will be used to analyze the percentage of responders to treatment compared with a reference value of 10%. Wilcoxon signed rank test will be used to compare the values of all continuous variables between baseline and post treatment. The population for safety analyses will include all subjects who receive at least one acupuncture treatment. Adverse events will be coded using the WHO Adverse Reaction Terminology Dictionary. Special attention will be given to those subjects who have discontinued treatment due to adverse events or who experience serious adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The University of Hong Kong
Hong Kong, Hong Kong
Change in Pain Severity Numerical Rating Scale (NRS)
Time frame: week 0 and 6
Types and dosage of drug(s) intake
Time frame: week 0, 2, 4, 6, 8, 10, 12, 14 and 18
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: week 0, 6, 10 and 18
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: week 0, 6, 10 and 18
Bath Ankylosing Spondylitis Global Index (BASGI)
Time frame: week 0, 6, 10 and 18
Quality of life of patients as evaluated by SF-36
Quality of life of patients will be measured.
Time frame: week 0, 6, 10 and 18
Bath Ankylosing spondylitis Metrology Index (BASMI)
Time frame: week 0, 6, 10 and 18
Chest expansion as measured by the change in circumference at 4th intercostal level between maximal inspiration and expiration in cm
Time frame: week 0, 6, 10 and 18
Joints count
Time frame: week 0, 6, 10 and 18
C-reactive protein (CRP)
Time frame: week 0, 6, 10 and 18
Erythrocyte sedimentation rate (ESR)
Time frame: week 0, 6, 10 and 18
Change in Pain Severity Numerical Rating Scale (NRS)
Time frame: week 0, 2, 4, 8, 10, 12, 14, and 18
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