NCT04071522

Brief Summary

The Back Beliefs Questionnaire (BBQ) developed by Symonds et al. in 1996 is used to measure patient's attitudes and beliefs towards recovery and return-to-work; and expectations regarding the negative circumstances that could be created as a result of low back pain (LBP).The aim of this study was the translation to Turkish language, cross-cultural adaptation and assessment of reliability\&validity of BBQ for the patients suffering from chronic LBP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

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

June 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

August 23, 2019

Last Update Submit

August 27, 2019

Conditions

Keywords

low back painturkish languagepain beliefsvalidity

Outcome Measures

Primary Outcomes (5)

  • Back Beliefs Questionnaire

    BBQ was designed to evaluate patients' LBP and their expectations regarding the negative outcomes that might be inflicted on their future; and their attitude towards return-to-work.BBQ consists of 14 items to be filled in by patients. Nine of which are used to evaluate inevitability (1st, 2nd, 3rd, 6th, 8th, 10th, 12th, 13th, 14th) and the other 5 are distractors (4th, 5th, 7th, 9th, 11th). All items are evaluated on a 5-point-Likert Scale that referred to "1-Definitely Disagree" and "5-Definitely Agree". Scoring is calculated over the expressions included in the inevitability measure by reversing the numerical values which are appointed by the participants. The resulting score is between 9 and 45. Lower scores supports the more incompatible and pessimistic beliefs.

    10 minutes

  • Numeric Rating Scale-Pain

    Numeric Rating Scale-Pain is a scale with good sensitivity that quantitatively evaluates the pain intensity, which is easily comparable to other pain scales. The patient defines pain level within a range of 1 to 10. 1 point represents the minumum pain level, while 10 indicates the most severe pain.

    2 minutes

  • Oswestry Disability Index

    Oswestry Disability Index is a scale that assesses the functional disability level associated with LBP. It consists of 10 items that each have 6 options, which are scored between 0-5. The patient's total score is divided by the maximum possible score and multiplied by 100; and a percentage score is thus attained. The resulting score is between 0 and 100. As the total score increases, the level of functional disability also increases

    5 minutes

  • Fear Avoidance Beliefs Questionnaire

    Fear Avoidance Beliefs Questionnaire evaluates the physical activity and work related beliefs of fear and avoidance that arise in patients with LBP. It consists of two subscales (physical activity and work) and 16 questions in total.The patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.

    3 minutes

  • Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients. The questionnaire comprises seven questions for anxiety and seven questions for depression. HADS scores were interpreted as follows for each subscale: mild=8-10, modarate=11-14, severe=15-21.

    3 minutes

Study Arms (1)

LBP

110 literate Turkish speaking patients suffering from low back pain (LBP) for over 3 months, within the age range 18-65 were included in the study.

Other: no intervention

Interventions

no intervention

LBP

Eligibility Criteria

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

Patients who consulted to our Physical Medicine and Rehabilitation clinic during the period between June 2018 and April 2018; and volunteered to participate in this study were evaluated.

You may qualify if:

  • Turkish speaking
  • Suffering from low back pain during activity for over 3 months

You may not qualify if:

  • pregnancy
  • malignancy
  • infections
  • fractures
  • inflammatory diseases
  • cognitive impairments that might create a problem in comprehending and filling the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BezmialemVU

Istanbul, Turkey (TĂ¼rkiye)

Location

Related Publications (22)

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    PMID: 23634830BACKGROUND
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    PMID: 23245607BACKGROUND
  • Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

    PMID: 8455963BACKGROUND
  • Linton SJ, Buer N, Vlaeyen J, Hellsing AL. Are fear-avoidance beliefs related to the inception of an episode of back pain? A prospective study. Psychol Health. 2000 Nov;14(6):1051-9. doi: 10.1080/08870440008407366.

    PMID: 22175261BACKGROUND
  • Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.

    PMID: 10626311BACKGROUND
  • Symonds TL, Burton AK, Tillotson KM, Main CJ. Do attitudes and beliefs influence work loss due to low back trouble? Occup Med (Lond). 1996 Feb;46(1):25-32. doi: 10.1093/occmed/46.1.25.

    PMID: 8672790BACKGROUND
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    PMID: 17957450BACKGROUND
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    PMID: 1827930BACKGROUND
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  • Dupeyron A, Lanhers C, Bastide S, Alonso S, Toulotte M, Jourdan C, Coudeyre E. The Back Belief Questionnaire is efficient to assess false beliefs and related fear in low back pain populations: A transcultural adaptation and validation study. PLoS One. 2017 Dec 6;12(12):e0186753. doi: 10.1371/journal.pone.0186753. eCollection 2017.

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    PMID: 11124727BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

June 1, 2018

Primary Completion

February 12, 2019

Study Completion

February 12, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Data will not be shared.

Locations