- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433311
The Effect of Exercise on Motion Perception and Fear in Low Back Pain
June 27, 2022 updated by: Mine ARGALI DENIZ, Suleyman Demirel University
The Effect of Exercise Program on Perception of Exercise and Fear of Movement in Nonspecific Low Back Pain
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mine ARGALI DENIZ, PT, PhD
- Phone Number: 05372798133
- Email: minedeniz@sdu.edu.tr
Study Contact Backup
- Name: Burcu Özüberk, Asist. Prof.
- Phone Number: 02882145413
- Email: burcuozuberk@klu.edu.tr
Study Locations
-
-
-
Isparta, Turkey, 32100
- Recruiting
- Mine ARGALI DENIZ
-
Contact:
- Mine ARGALI DENIZ, PT, PhD
- Phone Number: 05372798133
- Email: minedeniz@sdu.edu.tr
-
Contact:
- Mine ARGALI DENIZ, PT, PhD
- Phone Number: 05372798133
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Exercises
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
|
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
|
NO_INTERVENTION: Routine
Only routine treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Benefit/Barrier Scale
Time Frame: Change in participate in life ine one month
|
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.
|
Change in participate in life ine one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tampa Scale of Kinesiophobia
Time Frame: Change in participate in life ine one month
|
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.
|
Change in participate in life ine one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mine ARGALI DENIZ, PT, PhD, Suleyman Demirel University Education and Training Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 6, 2022
Primary Completion (ANTICIPATED)
September 20, 2022
Study Completion (ANTICIPATED)
December 25, 2022
Study Registration Dates
First Submitted
June 21, 2022
First Submitted That Met QC Criteria
June 21, 2022
First Posted (ACTUAL)
June 27, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 1, 2022
Last Update Submitted That Met QC Criteria
June 27, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 72867572-050.01.04-95550
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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