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Completed

NCT Number: NCT06006377

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

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.

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Key information

Conditions

Spine Disease Back Pain Bone Diseases Disc Herniation Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uskudar University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrotherapy

Other

hotpack electrotherapy ultrasound exercises

Backup therapy

Other

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

Primary outcomes

  1. 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".

  2. 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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2023
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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