Study Stopped
Covid-19 pandemi limited the number of patients who was applied physical therapy
The Effect of Physical Therapy on Sexual Function
The Effectiveness of Physical Therapy on Sexual Function in Patients With Low Back Pain
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2021
CompletedFirst Submitted
Initial submission to the registry
June 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2023
CompletedFirst Posted
Study publicly available on registry
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedAugust 30, 2023
August 1, 2023
2 years
June 25, 2021
August 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
change from disability scores at just after physical therapy and 3 months
Before, just after and 3 months later physical therapy
change from quality of life at just after physical therapy and 3 months
Before, just after and 3 months later physical therapy
change from mood at just after physical therapy and 3 months
Before, just after and 3 months later physical therapy
Study Arms (1)
Patients with low back pain
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- low back pain due to lumbar pathologies
- being sexually active
- have no contraindications for physical therapy agents
You may not qualify if:
- known sexual function problems,
- known psychiatric disease and/or are taking antidepressant
- diabetes mellitus,
- cardiovascular disease
- neurological diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prof Dr Cemil Taşçıoğlu Şehir Hastanesi
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunay ER
Prof Dr Cemil Taşçıoğlu Şehir Hastanesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 25, 2021
First Posted
August 30, 2023
Study Start
January 20, 2021
Primary Completion
January 20, 2023
Study Completion
September 1, 2023
Last Updated
August 30, 2023
Record last verified: 2023-08