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Electroacupuncture for Relieving Pain in Ankylosing Spondylitis

NCT02697968 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-09-23

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Electroacupuncture

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Lixing LAO, Ph.D. · The University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-09-30
Completion
2017-12-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02697968 on ClinicalTrials.gov