- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05927909
Validity and Reliability of the Turkish Version of the Low Back Activity Confidence Scale (Lobacs)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 aim of this study was to evaluate the validity and reliability and the Turkish version of the Low Back Activity Confidence Scale (Lobacs).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Bursa, Turkey
- Bursa Kestel State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Presence of mechanical low back pain for 3 weeks or more.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low Back Activity Confidence Scale (Lobacs)
Time Frame: baseline
|
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.
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baseline
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The Oswestry Back Pain Disability Questionnaire
Time Frame: baseline
|
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
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The Quebec back pain disability scale (QBPDS)
Time Frame: baseline
|
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.
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ender Salbaş, MD, Balikesir University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9999999992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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