The Effect of Physical Therapy on Sexual Function

Not Applicable

Suspended

• Conditions: Sexual Dysfunction; Low Back Pain
• Interventions: Device: Physical treatment agents

• Registration Number: NCT06017830
• Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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.

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-06-25
• Primary Completion: 2023-01-20
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Study First Posted: 2023-08-30
• Last Update Posted: 2023-08-30
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with low back pain	Physical treatment agents	-

Primary Outcome Measures

Name	Time	Method
change from sexual function scores at just after physical therapy and 3 months	Before, just after and 3 months later physical therapy	Female Sexual Function Index for women and International Index of Erectile Function for men will be used. There is no cut-off values. Better scores mean better results

Secondary Outcome Measures

Name	Time	Method
change from disability scores at just after physical therapy and 3 months	Before, just after and 3 months later physical therapy	Oswestry Disability Index will be used. min-max 0-100. better scores means worse results
change from mood at just after physical therapy and 3 months	Before, just after and 3 months later physical therapy	Hospital Anxiety and Depression Scale will be used. min-max 0-21. better score means better result.
change from quality of life at just after physical therapy and 3 months	Before, just after and 3 months later physical therapy	Short Form-12 will be used. min-max 0-100. better score means better quality of life.

Trial Locations

Locations (1)

Prof Dr Cemil Taşçıoğlu Şehir Hastanesi; 🇹🇷 Istanbul, Turkey