Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury

March 1, 2022 updated by: Second Affiliated Hospital of Wenzhou Medical University

Urodynamic Analysis of the Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury

Neurogenic bladder after spinal cord injury can be divided into detrusor hyperreflexia and detrusor non reflexia. Acupuncture is recognized as a safe and effective treatment. The most commonly used acupoints are Guanyuan, Zhongji and Sanyinjiao. The purpose of this study is to clarify the therapeutic effects of different acupoints on different types of bladder. Main process: routine urodynamic examination was performed first, and then electroacupuncture was given to Guanyuan, Zhongji and Sanyinjiao points respectively, and urodynamic examination was performed again to observe the effect of Electroacupuncture on urodynamic parameters in real time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients diagnosed with traumatic suprasacral SCI.
  • the period of the spinal shock has passed.
  • patients with voiding dysfunction after SCI.
  • patients had stable condition, and suitable for treatment.
  • agreed to engage in our study and sign the informed consent.

Exclusion Criteria:

  • Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system, endocrine system and psychosis.
  • dysuria caused by non spinal cord injury, such as prostatic hypertrophy, urethral obstruction, operation.
  • Patients who have already taken cystostomy and sacral electrode implantation.
  • Patients with urinary tract infection.
  • Autonomic hyperreflexes were obvious.
  • Unable to cooperate with the healer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: sanyinjiao group
Perpendicular insertion about 0.8-1.2cun at bilateral sanyinjiao(SP6) acupoint.Then,bilateral SP6 were connected with Electronic Acupuncture Treatment Instrument (KWD-808-I,Yingdi, China). The frequency of the pulse was 20 Hz with a pulse duration of 200 us.Intensity of stimulus was depending on patient's tolerance.
Other: electroacupuncture
electroacupuncture at Sanyinjiao (SP6)
ACTIVE_COMPARATOR: guanyuan group
Perpendicular insertion about 0.8-1.2cun at bilateral Guanyuan(CV4), Zhongji (CV3) acupoints.Then,the two acupoints were connected with Electronic Acupuncture Treatment Instrument (KWD-808-I,Yingdi, China). The frequency of the pulse was 20 Hz with a pulse duration of 200 us.Intensity of stimulus was depending on patient's tolerance.
Other: electroacupuncture
electroacupuncture at Sanyinjiao (SP6)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perianal surface electromyography
Time Frame: Procedure (While doing acupuncture )
Perianal surface electromyography
Procedure (While doing acupuncture )
detrusor overactivity (DO)
Time Frame: Procedure (While doing acupuncture )
detrusor overactivity in milliliter,one of the urodynamic parameters
Procedure (While doing acupuncture )
bladder compliance (BC)
Time Frame: Procedure (While doing acupuncture )
bladder compliance in ml/cmH2O,one of the urodynamic parameters
Procedure (While doing acupuncture )
maximum cystometric capacity (MCC)
Time Frame: Procedure (While doing acupuncture )
maximum cystometric capacity in milliliter,one of the urodynamic parameters
Procedure (While doing acupuncture )
maximum urinary flow rate (Qmax)
Time Frame: Procedure (While doing acupuncture )
maximum urinary flow rate in milliliter/second,one of the urodynamic parameters
Procedure (While doing acupuncture )
maximum detrusor pressure
Time Frame: Procedure (While doing acupuncture )
maximum detrusor pressure at filling stage and voiding stage
Procedure (While doing acupuncture )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2021

Primary Completion (ANTICIPATED)

July 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

March 1, 2022

First Posted (ACTUAL)

March 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2021-15-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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