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NCT Number: NCT02697968

Electroacupuncture for Relieving Pain in Ankylosing Spondylitis

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Electroacupuncture

Device

Primary outcomes

  1. Change in Pain Severity Numerical Rating Scale (NRS)

    Time frame: week 0 and 6

Secondary outcomes

  1. Types and dosage of drug(s) intake

    Time frame: week 0, 2, 4, 6, 8, 10, 12, 14 and 18

  2. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: week 0, 6, 10 and 18

  3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: week 0, 6, 10 and 18

  4. Bath Ankylosing Spondylitis Global Index (BASGI)

    Time frame: week 0, 6, 10 and 18

  5. Quality of life of patients as evaluated by SF-36

    Time frame: week 0, 6, 10 and 18

    Quality of life of patients will be measured.

  6. Bath Ankylosing spondylitis Metrology Index (BASMI)

    Time frame: week 0, 6, 10 and 18

  7. 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

  8. Joints count

    Time frame: week 0, 6, 10 and 18

  9. C-reactive protein (CRP)

    Time frame: week 0, 6, 10 and 18

  10. Erythrocyte sedimentation rate (ESR)

    Time frame: week 0, 6, 10 and 18

  11. Change in Pain Severity Numerical Rating Scale (NRS)

    Time frame: week 0, 2, 4, 8, 10, 12, 14, and 18

Other outcomes

  1. Number of patients withdraw and the corresponding reasons

    Time frame: 18 weeks

  2. Number of subjects with and corresponding types of adverse events

    Time frame: 18 weeks

  3. Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)

    Time frame: Week 0,6 and 10

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2016
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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