NCT05433311

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

June 21, 2022

Last Update Submit

June 27, 2022

Conditions

Keywords

nonspesific low back painflexibilitykinesiphobiapain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change in participate in life ine one month

Secondary Outcomes (1)

  • Tampa Scale of Kinesiophobia

    Change in participate in life ine one month

Study Arms (2)

Exercises

ACTIVE COMPARATOR

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

Routine

NO INTERVENTION

Only routine treatment

Interventions

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

Exercises

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mine ARGALI DENIZ

Isparta, 32100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back PainPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mine ARGALI DENIZ, PT, PhD

    Suleyman Demirel University Education and Training Hospital

    STUDY DIRECTOR

Central Study Contacts

Mine ARGALI DENIZ, PT, PhD

CONTACT

Burcu Özüberk, Asist. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Clinical Physiotherapist

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

January 6, 2022

Primary Completion

September 20, 2022

Study Completion

December 25, 2022

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations