The Effect of Physical Therapy on Sexual Function

NCT ID: NCT06017830

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2023-09-30

Brief Summary

Sexual function in low back pain and after lumbar surgery has been evaluated in many studies In a few studies, sexual function problems after surgery have also been reported. In the literature, there is no study that investigates the effectiveness of physical therapy on sexual function in patients with low back pain. In this study, the effectiveness of physical therapy on sexual function in patients with low back pain will be evaluated.

Detailed Description

63 patients who had chronic low back pain who applied to City Hospital, Physical Medicine and Rehabilitation Department between January 2021 and January 2023 were enrolled in the study. Sexually active patients between the ages of 18 and 60, for whom physical therapy was planned for low-back pain related to lumbar pathologies, were included in the study. Informed consent was obtained from all patients. Exclusion criteria were defined as having contraindications for any physical therapy agents, having cardiovascular, neurological, psychiatric disease, or sexual disorders.

Short Form-12 (SF-12), Oswestry Disability Index (ODI), and Hospital Anxiety and Depression Scale (HAD) were recorded. International Index of Erectile Function (IIEF) and Female Sexual Function Index (FSFI) were utilized to evaluate sexual function

Fifteen sessions of physical therapy were planned for each patient. The physical therapy program included 15 minutes of conventional transcutaneous electrical nerve stimulation, 10 minutes of ultrasound, and 15 minutes of superficial heaters such as hot packs or infrarouge. All patients were evaluated the day before the first physical therapy session, the one-month and three-month after the last physical therapy session.

Conditions

Sexual Dysfunction; Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Patients with low back pain

Group Type: EXPERIMENTAL

Physical treatment agents

Intervention Type: DEVICE

Physical treatment agents such as TENS (transcutaneous electric nerve stimulation), hot pack and ultrasound will be applied to patients with low back pain. Sexual function will be assessed before, just after and 3 months later physical therapy.

Interventions

Physical treatment agents

Physical treatment agents such as TENS (transcutaneous electric nerve stimulation), hot pack and ultrasound will be applied to patients with low back pain. Sexual function will be assessed before, just after and 3 months later physical therapy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• low back pain due to lumbar pathologies
• being sexually active
• have no contraindications for physical therapy agents

Exclusion Criteria

• known sexual function problems,
• known psychiatric disease and/or are taking antidepressant
• diabetes mellitus,
• cardiovascular disease
• neurological diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role: lead

Responsible Party

Gunay ER

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gunay ER

Role: PRINCIPAL_INVESTIGATOR

Prof Dr Cemil Taşçıoğlu Şehir Hastanesi

Locations

Prof Dr Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

48670771-514

Identifier Type: -

Identifier Source: org_study_id