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Electroacupuncture for Relieving Pain in Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Electroacupuncture
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electroacupuncture

Arm Description

Outcomes

Primary Outcome Measures

Change in Pain Severity Numerical Rating Scale (NRS)

Secondary Outcome Measures

Types and dosage of drug(s) intake
Bath Ankylosing Spondylitis Functional Index (BASFI)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Bath Ankylosing Spondylitis Global Index (BASGI)
Quality of life of patients as evaluated by SF-36
Quality of life of patients will be measured.
Bath Ankylosing spondylitis Metrology Index (BASMI)
Chest expansion as measured by the change in circumference at 4th intercostal level between maximal inspiration and expiration in cm
Joints count
C-reactive protein (CRP)
Erythrocyte sedimentation rate (ESR)
Change in Pain Severity Numerical Rating Scale (NRS)

Full Information

First Posted
February 24, 2016
Last Updated
September 19, 2019
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02697968
Brief Title
Electroacupuncture for Relieving Pain in Ankylosing Spondylitis
Official Title
Electroacupuncture for Relieving Pain in Ankylosing Spondylitis: a Single-arm Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Primary Outcome Measure Information:
Title
Change in Pain Severity Numerical Rating Scale (NRS)
Time Frame
week 0 and 6
Secondary Outcome Measure Information:
Title
Types and dosage of drug(s) intake
Time Frame
week 0, 2, 4, 6, 8, 10, 12, 14 and 18
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame
week 0, 6, 10 and 18
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame
week 0, 6, 10 and 18
Title
Bath Ankylosing Spondylitis Global Index (BASGI)
Time Frame
week 0, 6, 10 and 18
Title
Quality of life of patients as evaluated by SF-36
Description
Quality of life of patients will be measured.
Time Frame
week 0, 6, 10 and 18
Title
Bath Ankylosing spondylitis Metrology Index (BASMI)
Time Frame
week 0, 6, 10 and 18
Title
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
Title
Joints count
Time Frame
week 0, 6, 10 and 18
Title
C-reactive protein (CRP)
Time Frame
week 0, 6, 10 and 18
Title
Erythrocyte sedimentation rate (ESR)
Time Frame
week 0, 6, 10 and 18
Title
Change in Pain Severity Numerical Rating Scale (NRS)
Time Frame
week 0, 2, 4, 8, 10, 12, 14, and 18
Other Pre-specified Outcome Measures:
Title
Number of patients withdraw and the corresponding reasons
Time Frame
18 weeks
Title
Number of subjects with and corresponding types of adverse events
Time Frame
18 weeks
Title
Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)
Time Frame
Week 0,6 and 10

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixing LAO, Ph.D.
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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Electroacupuncture for Relieving Pain in Ankylosing Spondylitis

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