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

NCT04519866 | Unknown

• 1 other identifier: 2019/2435
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acupuncture; Electroacupuncture; Manual acupuncture

Outcome Measures

Primary Outcomes (1)

• Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups

  Mean difference in BASDAI score between both groups from baseline to weeks 3, 6, 9 and 12. BASDAI score ranges from 0-10, with higher scores indicating higher disease activity.

  Week 3, 6, 9, 12

Secondary Outcomes (8)

• Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) score between both groups

  Week 6, 12, 24

• Mean difference in Bath Ankylosing Spondylitis Patient Global score (BAS-G) between both groups

  Week 6, 12, 24

• Mean difference in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) score between both groups

  Week 6, 12, 24

• Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) score between both groups

  Week 6, 12, 24

• Mean difference in EuroQol- 5 Dimension (EQ-5D) score between both groups

  Week 6, 12, 24

Other Outcomes (9)

• Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups

  Week 52

• Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) score between both groups

  Week 52

• Mean difference in Bath Ankylosing Spondylitis Patient Global score (BAS-G) between both groups

  Week 52

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

In addition to usual rheumatological care, patients in the electroacupuncture arm will undergo 2 courses of electroacupuncture treatment. Each treatment course will consist of 10 acupuncture sessions held over 5 weeks. Patient will take a break of 5-7 days in between each course of acupuncture.

Other: Electroacupuncture

Manual acupuncture

ACTIVE COMPARATOR

In addition to usual rheumatological care, patients in the manual acupuncture arm will undergo 2 courses of manual acupuncture treatment. Each treatment course will consist of 10 acupuncture sessions held over 5 weeks. Patient will take a break of 5-7 days in between each course of acupuncture.

Other: Manual acupuncture

Interventions

Electroacupuncture OTHER

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.

Electroacupuncture

Manual acupuncture OTHER

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).

Manual acupuncture

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21 years of age or older
• Diagnosed with AxSpA according to the 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria
• Bath AS Disease Activity Index (BASDAI) score ≥4 on a 11-point Numerical Rating Scale (NRS)
• Failed 2 sequential NSAIDs (including cyclooxygenase-2 inhibitor) at maximal tolerated doses for ≥4 weeks in total
• Patients on concomitant biological therapy (e.g. tumour necrosis factor inhibitor therapy, anti-interleukin 17) or non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g. methotrexate (MTX) or sulfasalazine (SSZ) or leflunomide (LEF)) at study entry must be on the drug for ≥12 weeks and at stable dose for ≥4 weeks prior to randomisation
• Patients taking systemic corticosteroids have to be on stable dose of ≤10mg/day prednisolone or equivalent for at least two weeks before randomisation.

You may not qualify if:

• Pregnant or breastfeeding women
• With bleeding disorders
• With blood-borne communicable diseases (e.g. hepatitis B, hepatitis C, human immunodeficiency virus, etc)
• With implantable electrical device (e.g. pacemaker)
• Suffering from impaired skin sensation or serious skin lesions along the vertebrae

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator
• National University of Singapore: collaborator
• Thong Chai Institute of Medical Research: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

Related Publications (1)

• Kwan YH, Fong W, Ang XL, Tan CS, Tai BC, Huang Y, Bilger M, Phang JK, Tan HC, Lee JV, Sun L, Tan CT, Dong BQ, Koh HL, Leung YY, Lui NL, Yeo SI, Ng SC, Fong KY, Thumboo J, Ostbye T. Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial. Trials. 2019 Jan 14;20(1):46. doi: 10.1186/s13063-018-3117-2.

  PMID: 30642381 BACKGROUND

MeSH Terms

Conditions

Spondylarthritis; Axial Spondyloarthritis

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spondylarthropathies; Ankylosis

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

• Warren Fong

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Warren Fong

CONTACT

+65 63214028; warren.fong.w.s@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: February 24, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)