Sacral Nerve Stimulation for Mild-to-Moderate or Refractory Rheumatoid Arthritis

NCT04821050 | Unknown

• 1 other identifier: 202002053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will assess the efficacy of sacral never stimulation (SNS) for the treatment of adult patients with active, mild-to-moderate rheumatoid arthritis or those with refractory disease. The study will enroll 60 subjects in a single center. All eligible subjects will be randomly divided into two groups at a ratio of 1:1. Half of the subjects will receive SNS (treatment) and the other half will receive sham stimulation (control). Subjects will be followed up for 2-4 weeks, according to their response to the treatment. Disease activity score, patient report outcomes and serum inflammatory cytokines will be observed before and after treatment.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; Sacral nerve; Sacral nerve stimulation; Neuromodulation; randomized clinical trial; drug refractory

Outcome Measures

Primary Outcomes (1)

• The American College of Rheumatology (ACR) 20 response at Week 2 from Day 0

  Difference between treatment and control groups in the proportion of subjects who achieve at least 20% improvement from baseline to Week 2 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worse) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worse), subject pain (0=no pain to 10=worse), evaluator's global assessment (0=best to 10=worse), or high sensitivity C-reactive protein (hsCRP) concentration (mg/mL) with higher values representing worse outcome.

  Week 2

Secondary Outcomes (4)

• 1. The Disease Activity Score 28-C-reactive protein (DAS28-CRP) good or moderate response as defined by European League Against Rheumatism (EULAR)

  week 2

• DAS28-CRP response (MCID -1.2) at Week 2

  wee 2

• 3. Health Assessment Questionnaire Disability Index (HAQ-DI) response (MCID -0.22)

  week 2

• Pain Visual Analogue Scale (scoring range 0 ~ 10)

  week 2

Study Arms (2)

Treatment

EXPERIMENTAL

Sacral nerve stimulation

Device: Sacral nerve stimulation

Control

SHAM COMPARATOR

Sham stimulation

Device: Sham stimulation

Interventions

Sacral nerve stimulation DEVICE

A senior acupuncture doctor will pierce filiform needles through the sacral foramen into the S3 and S4 sacral nerves. These sites correspond to the Zhongliao and Xialiao acupoints in Traditional Chinese Medicine. Electrodes will be clamped on the filiform needles and an electrical current of 0.5 mA will be delivered. The stimulation will last for 60 minutes every time, once a day for 2 weeks.

Treatment

Sham stimulation DEVICE

Shallow acupuncture stimulation will be performed at sites 8-10cm away from the acupoints in Group 1. Electrodes will be clamped on the filiform needles and an electrical current of 0.5 mA will be delivered. The stimulation will last for 60 minutes every time, once a day for 2 weeks.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age at screening
• Met the American College of Rheumatology criteria (2010) for RA
• Active mild to moderate RA (defined as 3.2 \< DAS28-CRP\< 5.1) naïve to any medication; or refractory RA who demonstrated an inadequate response or loss of response to 2 or more conventional synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) after treatment for at least 6 months.

You may not qualify if:

• Any severe chronic or uncontrolled comorbid disease, such as important organ failure, degree II and III heart block, clinically significant cardiovascular disease, severe infection, tumor, etc;
• Combined with other connective tissue diseases
• Cognitive impairment and can't cooperate
• Pregnancy or breastfeeding
• Bleeding or coagulation disorders
• Localized skin infections
• Intra-articular corticosteroid or pulse steroid within 2 weeks preceding the study

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Dinglei Su

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Minning Shen, associate professor

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dinglei Su, Dr.

CONTACT

+8613814011654; sudinglei@163.com

Study Design

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

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: March 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 4, 2022

Record last verified: 2021-03

Locations

CN (1)