NCT06017830

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

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

June 25, 2021

Last Update Submit

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

EXPERIMENTAL
Device: Physical treatment agents

Interventions

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.

Patients with low back pain

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalLow Back Pain

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gunay ER

    Prof Dr Cemil Taşçıoğlu Şehir Hastanesi

    PRINCIPAL INVESTIGATOR

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

Locations