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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06006377
• Other study ID #: Uskudar56
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Disc Herniation
• Intervertebral Disc Displacement
• Neck Pain
• Spinal Diseases
• Spine Disease

Intervention

Other:
• conventional physiotherapy
hotpack electrotherapy ultrasound exercises
• 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

Locations

Country	Name	City	State
Turkey	Uskudar University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Childress MA, Becker BA. Nonoperative Management of Cervical Radiculopathy. Am Fam Physician. 2016 May 1;93(9):746-54. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	12 weeks
Primary	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.	12 weeks