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

Sponsor
Uskudar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06006377
Collaborator
(none)
30
1
2
3
10.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: conventional physiotherapy
  • Other: Backup therapy
N/A

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 10 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
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
conventional physiotherapy and backup device therapyconventional physiotherapy and backup device therapy
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Nov 15, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: conventional

conventional physiotherapy methods

Other: conventional physiotherapy
hotpack electrotherapy ultrasound exercises

Experimental: backup

Physiotherapy applied with backup device

Other: conventional physiotherapy
hotpack electrotherapy ultrasound exercises

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

Outcome Measures

Primary Outcome Measures

  1. Pittsburgh Sleep Quality Index [12 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 [12 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uskudar University Istanbul Turkey

Sponsors and Collaborators

  • Uskudar University

Investigators

  • Study Chair: Asiye ÖNELGE, Uskudar University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
ClinicalTrials.gov Identifier:
NCT06006377
Other Study ID Numbers:
  • Uskudar56
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2023