Electroacupuncture for Relieving Pain in Ankylosing Spondylitis

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.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Device: Electroacupuncture

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture	Device: Electroacupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Pain Severity Numerical Rating Scale (NRS)	week 0 and 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types and dosage of drug(s) intake		week 0, 2, 4, 6, 8, 10, 12, 14 and 18
Bath Ankylosing Spondylitis Functional Index (BASFI)		week 0, 6, 10 and 18
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)		week 0, 6, 10 and 18
Bath Ankylosing Spondylitis Global Index (BASGI)		week 0, 6, 10 and 18
Quality of life of patients as evaluated by SF-36	Quality of life of patients will be measured.	week 0, 6, 10 and 18
Bath Ankylosing spondylitis Metrology Index (BASMI)		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		week 0, 6, 10 and 18
Joints count		week 0, 6, 10 and 18
C-reactive protein (CRP)		week 0, 6, 10 and 18
Erythrocyte sedimentation rate (ESR)		week 0, 6, 10 and 18
Change in Pain Severity Numerical Rating Scale (NRS)		week 0, 2, 4, 8, 10, 12, 14, and 18

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients withdraw and the corresponding reasons	18 weeks
Number of subjects with and corresponding types of adverse events	18 weeks
Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)	Week 0,6 and 10

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Lixing LAO, Ph.D., The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: February 28, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: UW 15-458