The Effect of Physical Therapy on Sexual Function

August 28, 2023 updated by: Gunay ER, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Prof Dr Cemil Taşçıoğlu Şehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from sexual function scores at just after physical therapy and 3 months
Time Frame: 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
Before, just after and 3 months later physical therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from disability scores at just after physical therapy and 3 months
Time Frame: Before, just after and 3 months later physical therapy
Oswestry Disability Index will be used. min-max 0-100. better scores means worse results
Before, just after and 3 months later physical therapy
change from quality of life at just after physical therapy and 3 months
Time Frame: 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.
Before, just after and 3 months later physical therapy
change from mood at just after physical therapy and 3 months
Time Frame: 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.
Before, just after and 3 months later physical therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

January 20, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48670771-514

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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