Electroacupuncture for Relieving Pain in Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

Electroacupuncture for Relieving Pain in Ankylosing Spondylitis: a Single-arm Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697968
• Other study ID #: UW 15-458
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: September 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Device:
• Electroacupuncture

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients withdraw and the corresponding reasons		18 weeks
Other	Number of subjects with and corresponding types of adverse events		18 weeks
Other	Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)		Week 0,6 and 10
Primary	Change in Pain Severity Numerical Rating Scale (NRS)		week 0 and 6
Secondary	Types and dosage of drug(s) intake		week 0, 2, 4, 6, 8, 10, 12, 14 and 18
Secondary	Bath Ankylosing Spondylitis Functional Index (BASFI)		week 0, 6, 10 and 18
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)		week 0, 6, 10 and 18
Secondary	Bath Ankylosing Spondylitis Global Index (BASGI)		week 0, 6, 10 and 18
Secondary	Quality of life of patients as evaluated by SF-36	Quality of life of patients will be measured.	week 0, 6, 10 and 18
Secondary	Bath Ankylosing spondylitis Metrology Index (BASMI)		week 0, 6, 10 and 18
Secondary	Chest expansion as measured by the change in circumference at 4th intercostal level between maximal inspiration and expiration in cm		week 0, 6, 10 and 18
Secondary	Joints count		week 0, 6, 10 and 18
Secondary	C-reactive protein (CRP)		week 0, 6, 10 and 18
Secondary	Erythrocyte sedimentation rate (ESR)		week 0, 6, 10 and 18
Secondary	Change in Pain Severity Numerical Rating Scale (NRS)		week 0, 2, 4, 8, 10, 12, 14, and 18