Ankylosing Spondylitis Clinical Trial
Official title:
Electroacupuncture for Relieving Pain in Ankylosing Spondylitis: a Single-arm Pilot Study
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.
n/a
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