The Effect of Physical Therapy on Sexual Function

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)

Overall Status

Suspended

CT.gov ID

NCT06017830

Collaborator

(none)

Enrollment

Location

Arm

31.3

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction Low Back Pain	Device: Physical treatment agents	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jan 20, 2021

Actual Primary Completion Date :

Jan 20, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with low back pain	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.

Arm

Intervention/Treatment

Experimental: Patients with low back pain

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.

Outcome Measures

Primary Outcome Measures

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

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 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof Dr Cemil Taşçıoğlu Şehir Hastanesi	Istanbul		Turkey

Sponsors and Collaborators

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

Principal Investigator: Gunay ER, Prof Dr Cemil Taşçıoğlu Şehir Hastanesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gunay ER, Principal Investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

ClinicalTrials.gov Identifier:

NCT06017830

Other Study ID Numbers:

48670771-514

First Posted:

Aug 30, 2023

Last Update Posted:

Aug 30, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Aug 30, 2023