Clinical trial NCT06017830: The Effect of Physical Therapy on Sexual Function
Official title: The Effectiveness of Physical Therapy on Sexual Function in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Sexual Dysfunction
Low Back Pain
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: change from sexual function scores at just after physical therapy and 3 months
timeFrame: Before, just after and 3 months later physical therapy
Secondary outcomes:
measure: change from disability scores at just after physical therapy and 3 months
timeFrame: Before, just after and 3 months later physical therapy
measure: change from quality of life at just after physical therapy and 3 months
timeFrame: Before, just after and 3 months later physical therapy
measure: change from mood at just after physical therapy and 3 months
timeFrame: Before, just after and 3 months later physical therapy
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof Dr Cemil Taşçıoğlu Şehir Hastanesi
Study officials:
affiliation: Prof Dr Cemil Taşçıoğlu Şehir Hastanesi
name: Gunay ER
role: PRINCIPAL_INVESTIGATOR
References: