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Clinical Trials/NCT06006377
NCT06006377CompletedNot Applicable

Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies

Uskudar University2 sites in 2 countries30 target enrollmentStarted: September 1, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Pittsburgh Sleep Quality Index

Study Overview

Brief Summary

Our aim in this study is to examine the effectiveness of the Backup spine health device in spinal problems and compare it with traditional physical therapy methods.

Detailed Description

The investigators study was planned as a randomized controlled study. Participants will be divided into 2 groups as conventional physiotherapy and Backup group by simple randomized method. Participants will be taken to a treatment program for 12 weeks, 3 days a week. Parameters such as pain, posture, sleep quality, quality of life, muscle shortening at the beginning and end of the study. The results will be analyzed statistically.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Being between the ages of 20-60
  • sick individuals with spinal problems
  • Persons who have filled out the consent form

Exclusion Criteria

  • People with spinal pathology for whom physiotherapy is contraindicated
  • Having a neurological problem

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Index

Time Frame: 14 weeks

It is a 19-item self-report scale that evaluates sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality".

World Health Organization Quality of Life Scale Short Form

Time Frame: 14 weeks

The scale is a 26-item scale. Each section and area receives a maximum score of 20 points or 100 points. A high score indicates good quality of life.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Uskudar University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Öğr. Üyesi Ömer Şevgin

Asst. Prof. Dr.

Uskudar University

Study Sites (2)

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