Low Back Pain, MechanicalNCT05927909
Validity and Reliability of the Turkish Version of the Low Back Activity Confidence Scale (Lobacs)
An observational study of Low Back Pain, Mechanical and Symptoms and Signs, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Mechanical, Symptoms and Signs
- What is being tested?
- Low Back Activity Confidence Scale (Lobacs)
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Presence of mechanical low back pain for 3 weeks or more.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
Read the 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).
- Conditions
- Low Back Pain, Mechanical, Symptoms and Signs
- Being tested
- Low Back Activity Confidence Scale (Lobacs)
- Keywords
- low back pain, Turkish adaptation, validity, reliability, Low Back Activity Confidence Scale (Lobacs)
- Medical subject headings
- Low Back Pain, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Back Activity Confidence Scale (Lobacs)Diagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jul 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sezin Solum, Bursa City Hospital
- Investigators
- Ender Salbaş, MD, Study director, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927909
- Sponsor's protocol ID
- 9999999992
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21852520Beaton 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.
PubMed 11124735Chung 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.
PubMed 9708370Yakut 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.
PubMed 15129077Melikoglu 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.
PubMed 19282728Mokkink 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.
PubMed 20169472
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Low Back Activity Confidence Scale (Lobacs)
- ClinicalTrials.gov ID
- NCT05927909
- Acronym / sponsor ID
- 9999999992
- Conditions
- Low Back Pain, Mechanical, Symptoms and Signs
- Keywords
- low back pain, Turkish adaptation, validity, reliability, Low Back Activity Confidence Scale (Lobacs)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Presence of mechanical low back pain for 3 weeks or more.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Back Activity Confidence Scale (Lobacs)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. | Diagnostic test | – |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Background: PubMed 21852520Yamada 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.
- Background: PubMed 11124735Beaton 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.
- Background: PubMed 9708370Chung 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.
- Background: PubMed 15129077Yakut 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.
- Background: PubMed 19282728Melikoglu 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.
- Background: PubMed 20169472Mokkink 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ender Salbaş, MD study director
Balikesir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, Mechanical and Symptoms and Signs, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Back Activity Confidence Scale (Lobacs) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927909, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.