Back to resultsInvestigation of the Efficacy of Treatments With Backup Device in Spine Pathologies
Primary Purpose
Spine Disease, Neck Pain, Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
conventional physiotherapy
Backup therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spine Disease focused on measuring Backup, physiotherapy
Eligibility Criteria
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
Sites / Locations
- Uskudar UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional
backup
Arm Description
conventional physiotherapy methods
Physiotherapy applied with backup device
Outcomes
Primary Outcome Measures
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".
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06006377
Brief Title
Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies
Official Title
Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Disease, Neck Pain, Back Pain, Disc Herniation
Keywords
Backup, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
conventional physiotherapy and backup device therapy
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional
Arm Type
Active Comparator
Arm Description
conventional physiotherapy methods
Arm Title
backup
Arm Type
Experimental
Arm Description
Physiotherapy applied with backup device
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
hotpack electrotherapy ultrasound exercises
Intervention Type
Other
Intervention Name(s)
Backup therapy
Intervention Description
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 Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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".
Time Frame
12 weeks
Title
World Health Organization Quality of Life Scale Short Form
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ömer şevgin
Phone
+90506 978 75 35
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asiye ÖNELGE
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Uskudar University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer ŞEVGİN
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26727925
Citation
Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.
Results Reference
background
PubMed Identifier
27175952
Citation
Childress MA, Becker BA. Nonoperative Management of Cervical Radiculopathy. Am Fam Physician. 2016 May 1;93(9):746-54.
Results Reference
background
PubMed Identifier
11552355
Citation
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.
Results Reference
background
PubMed Identifier
29139353
Citation
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.
Results Reference
background
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Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies
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