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The Effect of Exercise on Motion Perception and Fear in Low Back Pain

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercises
Sponsored by
Suleyman Demirel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring nonspesific low back pain, flexibility, kinesiphobia, pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Voluntarily accepting the study
  • Having nonspecific low back pain for 3 months or longer
  • Not having had spinal surgery in the last 6 months
  • Not having an orthopedic or neurological disability that would prevent them from doing their exercises
  • Patients who regularly continue their exercises without interrupting

Exclusion Criteria:

  • Patients with non-specific low back pain who do not meet the inclusion criteria and want to drop out of the study

Sites / Locations

  • Mine ARGALI DENIZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Exercises

Routine

Arm Description

Neutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises

Only routine treatment

Outcomes

Primary Outcome Measures

Exercise Benefit/Barrier Scale
This scale is a 4 scores Likert-type. Scale consisting 43 questions. A high score means exercise perception. When Benefit Scale is evaluated on its own, how high the total score of 29 items is it means that exercise perception is beneficial in high level. In Barrier Scale which consists 14 items, the higher obtained total score is, higher the barrier level perceived against exercise is.

Secondary Outcome Measures

Tampa Scale of Kinesiophobia
Tampa Scale of Kinesiophobia is a checklist of 17 questions. 4-point Likert scale on the scale rating (1= strongly disagree, 4= I totally agree). Person between 17-68 total gets a score. The score of the person on the scale high, kinesiophobia is also high. shows. Total score in studies use is recommended.

Full Information

First Posted
June 21, 2022
Last Updated
June 27, 2022
Sponsor
Suleyman Demirel University
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1. Study Identification

Unique Protocol Identification Number
NCT05433311
Brief Title
The Effect of Exercise on Motion Perception and Fear in Low Back Pain
Official Title
The Effect of Exercise Program on Perception of Exercise and Fear of Movement in Nonspecific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
September 20, 2022 (Anticipated)
Study Completion Date
December 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel 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
Nonspesific low back pain (NLBP), which negatively affects functionality, activity participation, and financial situation, is now one of the leading causes of disability in the world. In NLBP, pain causes kinesiophobia known as fear of movement and limitation of activity. Contrary to what is known, this cycle aggravates pain. With this result, it is suggested that the exercise to be done will improve the perception of benefit in the person and eliminate the fear of movement, and that it will cure the disease. In this context, the aim of the study is to examine the effect of exercise on the perception of exercise and fear of movement in patients with NLBP.
Detailed Description
The study will be composed of volunteers, non-specific low back pain individuals who meet the inclusion criteria. First of all, the demographic and clinical characteristics of the patients will be questioned with the evaluation form. The personal information of the patients (gender, height, weight, smoking, etc.) and clinical status (pain type, pain intensity, trunk flexibility measurements) will be recorded by the physiotherapist in the evaluation form. In addition to these measurements, the state of fear of physical movement and activity will be evaluated with the Tampa Kinesiophobia Scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
nonspesific low back pain, flexibility, kinesiphobia, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients included in the treatment group had 15 sessions. Neutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises will be done face-to-face with a physiotherapist. At the end of the 15 sessions of face-to-face training the patients will be perform the same exercises at home for 15 days. The patients will not given any exercises in the control group. Measurements and evaluations of the patients in the both groups will be made three that pre-treatment, post-treatment, 15 days after the end of treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercises
Arm Type
Active Comparator
Arm Description
Neutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises
Arm Title
Routine
Arm Type
No Intervention
Arm Description
Only routine treatment
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
Neutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises
Primary Outcome Measure Information:
Title
Exercise Benefit/Barrier Scale
Description
This scale is a 4 scores Likert-type. Scale consisting 43 questions. A high score means exercise perception. When Benefit Scale is evaluated on its own, how high the total score of 29 items is it means that exercise perception is beneficial in high level. In Barrier Scale which consists 14 items, the higher obtained total score is, higher the barrier level perceived against exercise is.
Time Frame
Change in participate in life ine one month
Secondary Outcome Measure Information:
Title
Tampa Scale of Kinesiophobia
Description
Tampa Scale of Kinesiophobia is a checklist of 17 questions. 4-point Likert scale on the scale rating (1= strongly disagree, 4= I totally agree). Person between 17-68 total gets a score. The score of the person on the scale high, kinesiophobia is also high. shows. Total score in studies use is recommended.
Time Frame
Change in participate in life ine one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Voluntarily accepting the study Having nonspecific low back pain for 3 months or longer Not having had spinal surgery in the last 6 months Not having an orthopedic or neurological disability that would prevent them from doing their exercises Patients who regularly continue their exercises without interrupting Exclusion Criteria: Patients with non-specific low back pain who do not meet the inclusion criteria and want to drop out of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mine ARGALI DENIZ, PT, PhD
Phone
05372798133
Email
minedeniz@sdu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu Özüberk, Asist. Prof.
Phone
02882145413
Email
burcuozuberk@klu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mine ARGALI DENIZ, PT, PhD
Organizational Affiliation
Suleyman Demirel University Education and Training Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Mine ARGALI DENIZ
City
Isparta
ZIP/Postal Code
32100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mine ARGALI DENIZ, PT, PhD
Phone
05372798133
First Name & Middle Initial & Last Name & Degree
Mine ARGALI DENIZ, PT, PhD
Phone
05372798133
Email
minedeniz@sdu.edu.tr

12. IPD Sharing Statement

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The Effect of Exercise on Motion Perception and Fear in Low Back Pain

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