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

NCT05262816 | Unknown

• 1 other identifier: SAHoWMU-CR2021-15-103
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Bladder

Keywords

Electroacupuncture; Neurogenic Bladder; Spinal Cord Injury

Outcome Measures

Primary Outcomes (6)

• Perianal surface electromyography

  Perianal surface electromyography

  Procedure (While doing acupuncture )

• detrusor overactivity (DO)

  detrusor overactivity in milliliter,one of the urodynamic parameters

  Procedure (While doing acupuncture )

• bladder compliance (BC)

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

  Procedure (While doing acupuncture )

• maximum cystometric capacity (MCC)

  maximum cystometric capacity in milliliter,one of the urodynamic parameters

  Procedure (While doing acupuncture )

• maximum urinary flow rate (Qmax)

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

  Procedure (While doing acupuncture )

• maximum detrusor pressure

  maximum detrusor pressure at filling stage and voiding stage

  Procedure (While doing acupuncture )

Study Arms (2)

sanyinjiao group

EXPERIMENTAL

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

guanyuan group

ACTIVE COMPARATOR

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

Interventions

electroacupuncture OTHER

electroacupuncture at Sanyinjiao (SP6)

guanyuan group; sanyinjiao group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Spinal Cord Injuries

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

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

Central Study Contacts

Junyan Lu

CONTACT

13968769904; huars03@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: March 2, 2022
• Study Start: August 20, 2021
• Primary Completion: July 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

CN (1)