Predictors of Self-management in Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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Supported self-management (SM) is one of the key recommendations in management of chronic low back pain (CLBP). SM programmes for patients with CLBP have failed to show clinically meaningful improvement in pain and disability markers, which potentially reflect the lack of treatment matching of SM programmes. Patient selection for a SM programme for patients with CLBP is particularly difficult due to lack of extensive research on what predicts SM and its change. The overarching purpose of this study is to identify predictors of SM and its change over time in patients with CLBP. This study is a prospective non-experimental longitudinal study.

Detailed Description
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Materials and methods: Patients will be recruited at baseline from the physiotherapy outpatient clinics. Three different methods have been planned to identify suitable patients in this study: from the outpatient clinics, through advertisements and therapist referrals to the study. All willing participants will be screened against the study selection criteria. Eligible participants will be provided with a pre-approved information sheet and verbal explanation about the study before obtaining written consent. The consenting patients will be requested to fill in the baseline questionnaire. The patients will be requested to fill the follow up questionnaire after six months from their baseline data collection via an online, telephone or paper-based questionnaire depending on their preference. Data required for the necessary agreement between paper-based and online or telephone survey, will be collected from up to 60 participants within two weeks from their baseline data collection. All patients will receive and continue their normal treatment as recommended by their primary care team. A participant may be withdrawn by the investigators, involved in major trauma or undergoes surgery, or a female participant becomes pregnant during the course of the study. Sample size was estimated using G*Power (version 3.1.5). The statistical analyses will be performed using a statistical software (IBM SPSS 22) with statistical significance set at p<0.05 for the entire analysis, unless mentioned. Descriptive statistics, interclass correlation coefficients, Bland-Altman limits of agreement plots, significance testing, correlations and regression analyses will be employed.

Official Title
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Predictors of Self-management in Patients With Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with low back pain for more than three months aged between 18 and 65 years at baseline, community ambulant without walking aids, attending or recently attended outpatient physiotherapy treatments in the UK National Health Service (NHS) for their chronic low back pain, and able to read, write and understand English for completing the questionnaires Exclusion Criteria: diagnosed with cancer or other self-reported specific cause [major trauma, fracture, ankylosing spondylitis, grade 3 & 4 spondylolisthesis, severe spinal canal stenosis, or lumbar intervertebral disc protrusion or extrusion, spinal deformity] for their chronic low back pain, underwent surgery within last one year for the lower back or are planning or scheduled for any major surgery in the coming six months, pregnant or experienced childbirth in the last one year, patients with cognitive impairment, neurological diseases, and severe vision and hearing impairments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|Patients will be allowed to continue their usual treatment as recommended by their care team.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Education Impact Questionnaire |  | baseline and 6-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of low back pain |  | baseline | 
| Numeric Pain Intensity Scale |  | baseline and 6-month follow up | 
| Roland Morris Disability Questionnaire |  | baseline and 6-month follow up | 
| International Physical Activity Questionnaire (Short Form) |  | baseline and 6-month follow up | 
| Tampa Scale of Kinesiophobia |  | baseline and 6-month follow up | 
| Pain Catastrophising Scale |  | baseline and 6-month follow up | 
| Patient Health Questionnaire 9 |  | baseline and 6-month follow up | 
| Patients Global Impression of Change |  | 6-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, chronic pain, self-management, longitudinal study, predictive modelling