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

Not Applicable

Completed

• Conditions: Spine Disease; Back Pain; Disc Herniation
• Interventions: Other: conventional physiotherapy; Other: Backup therapy

• Registration Number: NCT06006377
• Lead Sponsor: Uskudar University

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 Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Study Start: 2023-09-01
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional	conventional physiotherapy	conventional physiotherapy methods
backup	conventional physiotherapy	Physiotherapy applied with backup device
backup	Backup therapy	Physiotherapy applied with backup device

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	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	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.

Trial Locations

Locations (1)

Uskudar University; 🇹🇷 Istanbul, Turkey