NCT05927909

Brief Summary

Patients will be recruited from the Outpatient Department of Physical Medicine and Rehabilitation, Kestel State Hospital, who have been diagnosed with mechanical LBP for the past 3 weeks (physical examination, neurological examination, spinal radiography and laboratory tests and other causes of LBP were excluded) and who have agreed to participate in the study. Sociodemographic data of patients who gave written informed consent will be recorded to ensure anonymity. Although no consensus has been reached on the cross-cultural adaptation of the questionnaires into different languages, this study will use the guidelines for self-report measurement provided by Beaton et al. Following the formation of the expert committee, the scale will be translated and the pre-form back-translated. Comparisons will be made with the translated versions and the final version of the scale will be created by taking into account the opinions of the preliminary group of participants. The reliability, test-retest reliability, face validity and content validity of the scale will be assessed by the expert committee. In order to assess the concurrent validity of this scale, all participants will also complete the 'Oswestry Low Back Pain Disability Questionnaire' and the 'Quebec Low Back Pain Disability Questionnaire', which have been previously validated and reliable in Turkish. The Oswestry Low Back Pain Disability Questionnaire consists of 10 items that assess activities of daily living. These are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling and degree of change in pain. Each item has 6 options ranging from 0 to 5 points (12). The Quebec Low Back Pain Disability Questionnaire consists of 20 items assessing activities of daily living. Each item has 6 options ranging from 0-5 points. The aim of this study was to evaluate the validity and reliability and the Turkish version of the Low Back Activity Confidence Scale (Lobacs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 23, 2023

Last Update Submit

July 1, 2023

Conditions

Keywords

low back painTurkish adaptationvalidityreliabilityLow Back Activity Confidence Scale (Lobacs)

Outcome Measures

Primary Outcomes (3)

  • Low Back Activity Confidence Scale (Lobacs)

    The Low Back Activity Confidence Scale (LOBACS) is a self-report questionnaire comprising 15 items and three subscales: Functional Self-efficacy (FnSE), Self-regulatory Self-efficacy, and Exercise Self-efficacy (ExSE). Its purpose is to evaluate an individual's perceived functional ability and the impact of low back pain on their daily life and functional performance. The questionnaire employs an 11-point Likert scale, ranging from 0% (no confidence) to 100% (complete confidence), with 10% increments for each point. Scores can be calculated globally (e.g., average score of all items) or for specific domains (e.g., average score of items 1-7 for FnSE subscale). The total score can range from 0 to 100, where higher scores indicate greater self-efficacy.

    baseline

  • The Oswestry Back Pain Disability Questionnaire

    The Oswestry Back Pain Disability Questionnaire comprises 10 items that inquire about various daily activities, including pain intensity, self-care, lifting, walking, sitting, standing, sleeping, social life, traveling, and the extent of pain-related changes. Each item presents six response options, scored on a scale of 0 to 5 points.

    baseline

  • The Quebec back pain disability scale (QBPDS)

    The Quebec Back Pain Disability Scale consists of 20 daily activities that can be categorised into 6 types of activities: Sitting/standing, Walking, Moving, Bending, Bed/resting, Handling large/heavy objects. For each activity there are 6 response scores on a Likert scale from 0-5 (0 = no effort, 5 = unable). If the person feels really bad, they give it a score of 5. If they feel good with no problems, they give it a score of 0.

    baseline

Interventions

Confidence Scale (LOBACS) is a self-report questionnaire designed to assess an individual's level of confidence in performing various physical activities involving the lower back region, to evaluate their perceived functional ability, and to assess the impact of low back pain on their daily life and functional performance.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be recruited from the Outpatient Department of Physical Medicine and Rehabilitation, Kestel State Hospital, who have been diagnosed with mechanical LBP for the past 3 weeks (physical examination, neurological examination, spinal radiography and laboratory tests and other causes of LBP were excluded) and who have agreed to participate in the study.

You may qualify if:

  • Presence of mechanical low back pain for 3 weeks or more.

You may not qualify if:

  • Duration of pain is less than 3 weeks,
  • Evidence of non-mechanical causes of low back pain on imaging or laboratory tests.
  • Inflammatory diseases.
  • History of major surgery in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Kestel State Hospital

Bursa, Turkey (Türkiye)

Location

Related Publications (6)

  • Yamada KA, Lewthwaite R, Popovich JM Jr, Beneck GJ, Kulig K; Physical Therapy Clinical Research Network. The Low Back Activity Confidence Scale (LoBACS): preliminary validity and reliability. Phys Ther. 2011 Nov;91(11):1592-603. doi: 10.2522/ptj.20100135. Epub 2011 Aug 18.

    PMID: 21852520BACKGROUND
  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

    PMID: 11124735BACKGROUND
  • Chung KC, Pillsbury MS, Walters MR, Hayward RA. Reliability and validity testing of the Michigan Hand Outcomes Questionnaire. J Hand Surg Am. 1998 Jul;23(4):575-87. doi: 10.1016/S0363-5023(98)80042-7.

    PMID: 9708370BACKGROUND
  • Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.

    PMID: 15129077BACKGROUND
  • Melikoglu MA, Kocabas H, Sezer I, Bilgilisoy M, Tuncer T. Validation of the Turkish version of the Quebec back pain disability scale for patients with low back pain. Spine (Phila Pa 1976). 2009 Mar 15;34(6):E219-24. doi: 10.1097/BRS.0b013e3181971e2d.

    PMID: 19282728BACKGROUND
  • Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8. Epub 2010 Feb 19.

    PMID: 20169472BACKGROUND

MeSH Terms

Conditions

Low Back PainSigns and Symptoms

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsPathological Conditions, Signs and Symptoms

Study Officials

  • Ender Salbaş, MD

    Balikesir University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; Physical Medicine & Rehabilitation Specialist Physician

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

July 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations