search
Back to results

The Effect of Physical Therapy on Sexual Function

Primary Purpose

Sexual Dysfunction, Low Back Pain

Status
Suspended
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physical treatment agents
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sexual Dysfunction

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Prof Dr Cemil Taşçıoğlu Şehir Hastanesi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with low back pain

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
June 25, 2021
Last Updated
August 28, 2023
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT06017830
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Covid-19 pandemi limited the number of patients who was applied physical therapy
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Low Back Pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with low back pain
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Physical treatment agents
Intervention Description
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.
Primary Outcome Measure Information:
Title
change from sexual function scores at just after physical therapy and 3 months
Description
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
Time Frame
Before, just after and 3 months later physical therapy
Secondary Outcome Measure Information:
Title
change from disability scores at just after physical therapy and 3 months
Description
Oswestry Disability Index will be used. min-max 0-100. better scores means worse results
Time Frame
Before, just after and 3 months later physical therapy
Title
change from quality of life at just after physical therapy and 3 months
Description
Short Form-12 will be used. min-max 0-100. better score means better quality of life.
Time Frame
Before, just after and 3 months later physical therapy
Title
change from mood at just after physical therapy and 3 months
Description
Hospital Anxiety and Depression Scale will be used. min-max 0-21. better score means better result.
Time Frame
Before, just after and 3 months later physical therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunay ER
Organizational Affiliation
Prof Dr Cemil Taşçıoğlu Şehir Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof Dr Cemil Taşçıoğlu Şehir Hastanesi
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effect of Physical Therapy on Sexual Function

We'll reach out to this number within 24 hrs