Electroacupuncture for Relieving Pain in Ankylosing Spondylitis

NCT02697968 | Completed

• 1 other identifier: UW 15-458
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Change in Pain Severity Numerical Rating Scale (NRS)

  week 0 and 6

Secondary Outcomes (11)

• 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

  week 0, 6, 10 and 18

Other Outcomes (3)

• 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

Study Arms (1)

Electroacupuncture

EXPERIMENTAL

Device: Electroacupuncture

Interventions

Electroacupuncture DEVICE

Electroacupuncture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Lixing LAO, Ph.D.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, School of Chinese Medicine

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 3, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

HK (1)