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

Sponsor
Second Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05262816
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
16.3
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: electroacupuncture
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Urodynamic Analysis of the Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury
Actual Study Start Date :
Aug 20, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Perianal surface electromyography [Procedure (While doing acupuncture )]

    Perianal surface electromyography

  2. detrusor overactivity (DO) [Procedure (While doing acupuncture )]

    detrusor overactivity in milliliter,one of the urodynamic parameters

  3. bladder compliance (BC) [Procedure (While doing acupuncture )]

    bladder compliance in ml/cmH2O,one of the urodynamic parameters

  4. maximum cystometric capacity (MCC) [Procedure (While doing acupuncture )]

    maximum cystometric capacity in milliliter,one of the urodynamic parameters

  5. maximum urinary flow rate (Qmax) [Procedure (While doing acupuncture )]

    maximum urinary flow rate in milliliter/second,one of the urodynamic parameters

  6. maximum detrusor pressure [Procedure (While doing acupuncture )]

    maximum detrusor pressure at filling stage and voiding stage

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 the Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325027

Sponsors and Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT05262816
Other Study ID Numbers:
  • SAHoWMU-CR2021-15-103
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital of Wenzhou Medical University
Electroacupuncture
Neurogenic Bladder
Spinal Cord Injury
Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Bladder, Neurogenic

Study Results

No Results Posted as of Mar 2, 2022