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

NCT06006377 | Completed

• 1 other identifier: Uskudar56
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Disease; Back Pain; Disc Herniation

Keywords

Backup; physiotherapy

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index

  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

  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

Study Arms (2)

electrotherapy

ACTIVE COMPARATOR

conventional physiotherapy methods (hotpack, Ultrasound , Transcutaneous Electrical Nerve Stimulation)

Other: electrotherapy

backup

EXPERIMENTAL

conventional physiotherapy and backup device therapy

Other: Backup therapy

Interventions

electrotherapy OTHER

hotpack electrotherapy ultrasound exercises

electrotherapy

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

backup

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Uskudar University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.

  PMID: 26727925 BACKGROUND

• Stoll T, Germann D, Hagmann H. [Physiotherapy in lumbar disc herniation ]. Ther Umsch. 2001 Aug;58(8):487-92. doi: 10.1024/0040-5930.58.8.487. German.

  PMID: 11552355 BACKGROUND

• Andersen MO, Andresen AK, Lorenzen MD, Isenberg-Jorgensen A, Stottrup C. [Non-surgical treatment of lumbar radiculopathy]. Ugeskr Laeger. 2017 Nov 13;179(23):V05170397. Danish.

  PMID: 29139353 BACKGROUND

MeSH Terms

Conditions

Spinal Diseases; Back Pain; Intervertebral Disc Displacement

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Asiye ÖNELGE

  Uskudar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: conventional physiotherapy and backup device therapy

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: September 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 30, 2023
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)