The Effect of Physical Therapy on Sexual Function

Low Back Pain Clinical Trial

Official title:

The Effectiveness of Physical Therapy on Sexual Function in Patients With Low Back Pain

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06017830
• Other study ID #: 48670771-514
• Status: Suspended
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: September 2023

Study information

• Verified date: August 2023
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: September 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Sexual Dysfunction

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Prof Dr Cemil Tasçioglu Sehir Hastanesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from sexual function scores at just after physical therapy and 3 months	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	Before, just after and 3 months later physical therapy
Secondary	change from disability scores at just after physical therapy and 3 months	Oswestry Disability Index will be used. min-max 0-100. better scores means worse results	Before, just after and 3 months later physical therapy
Secondary	change from quality of life at just after physical therapy and 3 months	Short Form-12 will be used. min-max 0-100. better score means better quality of life.	Before, just after and 3 months later physical therapy
Secondary	change from mood at just after physical therapy and 3 months	Hospital Anxiety and Depression Scale will be used. min-max 0-21. better score means better result.	Before, just after and 3 months later physical therapy