Sacral Stimulation in Women With Low Back Pain: Effects on Pelvic Functions and Daily Life

NCT07094698 | Active Not Recruiting

• 1 other identifier: 61351342/020-1199
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pelvic floor dysfunction is a term used to describe a variety of disorders involving moderate to severe impairment of the pelvic floor muscles. The pelvic floor is a layer of muscle designed to support the abdominal organs and maintain urethral, anal, and vaginal continence. It includes the pubococcygeus, puborectalis, and iliococcygeus muscles. Pelvic floor muscle dysfunction, which causes significant morbidity particularly in women, is associated with stress urinary incontinence, anal and fecal incontinence, pelvic organ prolapse, and sexual dysfunction, all of which can negatively affect quality of life in women. Moreover, various comorbid conditions such as back and neck pain, asthma, cardiovascular diseases, and psychiatric disorders are also associated with pelvic floor dysfunction. In patients diagnosed with lumbar disc herniation, changes in pelvic floor muscle strength have been observed. These changes may be accompanied by urinary and sexual problems. Individuals with low back pain are at twice the risk of urinary incontinence compared to those without back pain, and strengthening of the pelvic floor muscles has been shown to reduce back pain. This study aims to understand the characteristics of transcutaneous sacral nerve stimulation, examine the neurophysiological basis of this treatment method, and evaluate its potential for future innovative approaches.

Conditions

Pelvic Floor Dysfunction; Low Back Pain

Keywords

sacral stimulation; Activities of daily living; sexual function

Outcome Measures

Primary Outcomes (3)

• Severity of constipation

  Constipation severity will be measured using the Constipation Severity Instrument (CSI). The scale consists of a total of 16 questions. The CSI includes subscales for colonic inertia, stool obstruction, and pain. The score for the colonic inertia subscale ranges from 0 to 29, the stool obstruction subscale from 0 to 28, and the pain subscale from 0 to 16. Therefore, the total possible score on the CSI ranges from 0 to 73. Higher scores on the scale indicate more severe symptoms.

  through study completion, an average of 2 months.

• Severity of urinary incontinence

  Urinary incontinence will be assessed using the King's Health Questionnaire (KHQ). The questionnaire, which consists of 32 items divided into two parts, is widely used to evaluate the quality of life in patients with incontinence. In addition to two single-item questions addressing general health status and the impact on quality of life, it includes seven multi-item subscales. These subscales are role limitations, physical limitations, social limitations, personal relationships limitations, emotional problems, sleep and energy disturbances related to incontinence, and severity measures of incontinence. The second part consists of an 11-item symptom severity scale that evaluates the presence and severity of urinary symptoms. Scores on the symptom severity scale range from 0 (best) to 30 (worst). Scores for the other KHQ domains range from 0 (best) to 100 (worst).

  through study completion, an average of 2 months.

• Sexual quality of life

  This scale is a six-point Likert type and consists of 18 items. Each item is expected to be answered based on the respondent's sexual life over the past four weeks. Each item is scored between 1 and 6. The total score on the scale ranges from 18 to 108. A higher score indicates better sexual quality of life.

  through study completion, an average of 2 months.

Study Arms (1)

Sacral stimulation

EXPERIMENTAL

A low-frequency (2-10 Hz) current with a pulse duration of 200 μs will be applied for 30 minutes, 5 days a week, under the supervision of a physiotherapist for 6 weeks.

Other: sacral stimulation

Interventions

sacral stimulation OTHER

A low-frequency (2-10 Hz) current with a pulse duration of 200 μs will be applied for 30 minutes, 5 days a week, under the supervision of a physiotherapist for 6 weeks.

Sacral stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Due to the nature of the condition being studied, only female participants will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having complaints of urinary incontinence Having complaints of low back pain Diagnosed with constipation according to Rome IV criteria Women with pelvic floor dysfunction Being under 65 years of age Having normal mood and memory functions Being able to speak Turkish Being literate Voluntarily agreeing to participate in the study

You may not qualify if:

• Neuromuscular diseases (such as Multiple Sclerosis, Parkinson's disease, Myasthenia Gravis, etc.) Malignant tumors Diabetes and other serious medical conditions Pelvic radiation, rectal surgery, spinal surgery Hysterectomy Pelvic inflammation Urinary tract infection Vaginitis Pacemaker implantation Pregnancy Cognitive impairment

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Medipol Acıbadem Regional Hospital

Istanbul, 34718, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• muhammed fatih kavak, dr

  Uskudar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Forty female volunteers aged 18 to 65 years with complaints of urinary incontinence will be included. Low-frequency (2-10 Hz) current with a pulse duration of 200 μs will be applied for 30 minutes, 5 days a week, under the supervision of a physiotherapist for 6 weeks.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

TU (1)