Clinical trial NCT02697968: Electroacupuncture for Relieving Pain in Ankylosing Spondylitis
Official title: Electroacupuncture for Relieving Pain in Ankylosing Spondylitis: a Single-arm Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. with a diagnosis of AS and fulfilled either ASAS criteria or Modified New York criteria,
2. Bath Ankylosing Spondylitis Disease Activity Index, BASDAI ≥4,
3. currently taking analgesic or NSAIDs for pain control,
4. spinal pain assessment score≥4 on a numerical rating scale (NRS; 0-10 scale)

Exclusion Criteria:

1. having active skin lesion or open wound over the needle placement areas;
2. having heart disease, bleeding disorder or taking anticoagulant drugs
3. have previous acupuncture experience 12 months before the baseline,
4. are pregnant, breast-feeding or of childbearing potential but not using adequate contraception;
5. having psoriasis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis or reactive arthritis;
6. having unstable medical condition such as liver and/or kidney failure or cancers.;
7. concurrently taking or injecting steroid.

Primary outcomes:
measure: Change in Pain Severity Numerical Rating Scale (NRS)
timeFrame: week 0 and 6
Secondary outcomes:
measure: Types and dosage of drug(s) intake
timeFrame: week 0, 2, 4, 6, 8, 10, 12, 14 and 18
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: week 0, 6, 10 and 18
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: week 0, 6, 10 and 18
measure: Bath Ankylosing Spondylitis Global Index (BASGI)
timeFrame: week 0, 6, 10 and 18
measure: Quality of life of patients as evaluated by SF-36
timeFrame: week 0, 6, 10 and 18
measure: Bath Ankylosing spondylitis Metrology Index (BASMI)
timeFrame: week 0, 6, 10 and 18
measure: Chest expansion as measured by the change in circumference at 4th intercostal level between maximal inspiration and expiration in cm
timeFrame: week 0, 6, 10 and 18
measure: Joints count
timeFrame: week 0, 6, 10 and 18
measure: C-reactive protein (CRP)
timeFrame: week 0, 6, 10 and 18
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: week 0, 6, 10 and 18
measure: Change in Pain Severity Numerical Rating Scale (NRS)
timeFrame: week 0, 2, 4, 8, 10, 12, 14, and 18
Other outcomes:
measure: Number of patients withdraw and the corresponding reasons
timeFrame: 18 weeks
measure: Number of subjects with and corresponding types of adverse events
timeFrame: 18 weeks
measure: Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)
timeFrame: Week 0,6 and 10
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Lixing LAO, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: