NCT05614674

Brief Summary

Self-efficacy is defined as a person's confidence or belief that one can achieve a certain behavioral or cognitive state. Self-efficacy is one of the most important assesment parameters in the self-management model. It is accepted that patients with chronic low back pain with high self-efficacy have a better prognosis than those with low self-efficacy. Due to the complex nature of pain; The relationship between psychological and physical parameters such as pain catastrophy, disability level, depression, physical performance, self-efficacy, pain intensity and fear avoidance arouses curiosity. The aim of this cross-sectional study is to examine the relationship between the level of self-efficacy and sensory, perceptual and motor skills in people with chronic low back pain.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

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

November 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

November 5, 2022

Last Update Submit

November 5, 2022

Conditions

Keywords

Back PainPropioceptionDepressionPain CatastrophizingFlexibilityBalance

Outcome Measures

Primary Outcomes (7)

  • Visual Analog Scale (VAS)

    Baseline

  • Pain Self-Efficacy Questionnaire (PSEQ)

    Baseline

  • Proprioception Measurement with G-Pro Phone App

    Baseline

  • Beck Depression Inventory (BDI)

    Baseline

  • Pain Catastrophizing Scale (PCS)

    Baseline

  • Sit and Reach Test (SRT)

    Baseline

  • Multidirectional Reach Test

    Baseline

Study Arms (2)

Healthy group

People who don't suffer from low back pain

People with low back pain

People who are suffering from low back pain. The pain level has to be at least 3 out of 10 according to Visual Analog Scale (VAS) to be in this group.

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study group will consist of 30-65 years old people who will be agreed to take part in the study. There will be two groups. 1 of them is healthy group and the other is for people with low back pain. The partipicians will be literate enough to answer the questions in scales and questionnares by themselves

You may qualify if:

  • Being minimum 30 maximum 65 years old
  • To be literate
  • Accepting to take part in the study
  • Being minimum 30 maximum 65 years old
  • Minimum 3 score from Visual Analog Scale (VAS)
  • Having low back pain for at least 3 months of time
  • To be literate
  • Accepting to take part in the study

You may not qualify if:

  • Any kind of surgery in low back area
  • Surgery story in lower extremities
  • Acute low back pain
  • Having a neurological disorder
  • Having a rheumatological disease which may cause to low back pain
  • Having a herniated disc that presses on the sacral nerves
  • Being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Back PainDepression

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Burak Kara, Bachelor

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Burak Kara, Bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

November 5, 2022

First Posted

November 14, 2022

Study Start

November 1, 2022

Primary Completion

January 1, 2023

Study Completion

May 1, 2023

Last Updated

November 14, 2022

Record last verified: 2022-11