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

April 29, 2025 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

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
        • Uskudar University

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:

  • 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 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: electrotherapy
conventional physiotherapy methods (hotpack, Ultrasound , Transcutaneous Electrical Nerve Stimulation)
Other: electrotherapy
hotpack electrotherapy ultrasound exercises
Experimental: backup
conventional physiotherapy and backup device therapy
Other: Backup therapy
The backup spine health device is in the form of a mat and provides segmental electrical stimulation to the spines. At the same time, the mat can heat up to 40 degrees during the treatment process. Backup spine health device is very effective in both reducing pain and strengthening the muscles with electrical stimulations by reaching even the deep muscles around the spine. Sessions consist of 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
14 weeks
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.
14 weeks

Collaborators and Investigators

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

Sponsor

Uskudar University

Investigators

  • Study Chair: Asiye ÖNELGE, Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2023

Primary Completion (Actual)

November 15, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uskudar56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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