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

Sponsor
Suleyman Demirel University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05433311
Collaborator
(none)
60
1
2
11.6
5.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercises
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
The Effect of Exercise Program on Perception of Exercise and Fear of Movement in Nonspecific Low Back Pain
Actual Study Start Date :
Jan 6, 2022
Anticipated Primary Completion Date :
Sep 20, 2022
Anticipated Study Completion Date :
Dec 25, 2022

Arms and Interventions

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

Other: 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

Outcome Measures

Primary Outcome Measures

  1. Exercise Benefit/Barrier Scale [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.

Secondary Outcome Measures

  1. Tampa Scale of Kinesiophobia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mine ARGALI DENIZ Isparta Turkey 32100

Sponsors and Collaborators

  • Suleyman Demirel University

Investigators

  • Study Director: Mine ARGALI DENIZ, PT, PhD, Suleyman Demirel University Education and Training Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mine ARGALI DENIZ, PhD, Clinical Physiotherapist, Suleyman Demirel University
ClinicalTrials.gov Identifier:
NCT05433311
Other Study ID Numbers:
  • 72867572-050.01.04-95550
First Posted:
Jun 27, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mine ARGALI DENIZ, PhD, Clinical Physiotherapist, Suleyman Demirel University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022