Clinical Trial of Electroacupuncture in Axial Spondyloarthritis (E-AcuSpA)

NCT04519866 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-12-26

No results posted yet for this study

Summary

Axial spondyloarthritis (AxSpA) is a chronic disease that causes severe disability and poor quality of life. Current treatment options are limited and there are still significant non-responders to current western medications. Manual acupuncture has been shown to reduce pain in patients with AxSpA. There have been reports of electroacupuncture demonstrating more sustained pain relief. Therefore, the investigators aim to determine the clinical effectiveness, safety and cost-effectiveness of electroacupuncture as compared to manual acupuncture for patients with AxSpA through a randomized controlled trial.

Conditions

  • Spondylarthritis
  • Axial Spondyloarthritis

Interventions

OTHER

Electroacupuncture

Manual acupuncture (see procedures below) will be administered first to obtain the "de qi" sensation. After "de qi" is obtained, the electroacupuncture unit will be connected to 1-3 pairs of acupoints. Current intensity used will be based on the tolerance of each patient. Needles with electrical stimulation will be retained for 30 min. Main acupoints will be Jingjin points (meridian sinews) along the Bladder meridian of Foot - Taiyang, such as Shenshuci, as well as Jingjin points (meridian sinews) at transverse process from L2 to L4, iliac crest and spinous process from S1 to S4. Secondary acupoints will also be selected based on patients' syndromes and symptoms.

OTHER

Manual acupuncture

After disinfecting the acupuncture points, acupuncture will be performed with the patient lying prone. Depending on the acupuncture points, 0.25mm X 25-75 mm sterile acupuncture needle will be used. Needles will be inserted 10-50 mm and either rotating manipulation or lifting-thrusting manipulation will be used to achieve "de qi" (a compositional sensation including soreness, numbness, distention and heaviness). Acupoints used will be similar to those mentioned for electroacupuncture (see above).

Sponsors & Collaborators

  • Duke-NUS Graduate Medical School

    collaborator OTHER
  • National University of Singapore

    collaborator OTHER
  • Thong Chai Institute of Medical Research

    collaborator OTHER
  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Warren Fong · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Singapore

Study Locations

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Entities

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 NCT04519866 on ClinicalTrials.gov