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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636777
• Other study ID #: 15084
• Secondary ID: 188664
• Status: Completed
• Start date: December 2015
• Est. completion date: February 2018

Study information

• Verified date: June 2018
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 A participant may be withdrawn by the investigators, involved in major trauma or undergoes surgery, or a female participant becomes pregnant during the course of the study.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• no intervention
Patients will be allowed to continue their usual treatment as recommended by their care team.

Locations

Country	Name	City	State
United Kingdom	Nottingham CityCare Partnership	Nottingham	Nottinghamshire
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health Education Impact Questionnaire		baseline and 6-month follow up
Secondary	Duration of low back pain		baseline
Secondary	Numeric Pain Intensity Scale		baseline and 6-month follow up
Secondary	Roland Morris Disability Questionnaire		baseline and 6-month follow up
Secondary	International Physical Activity Questionnaire (Short Form)		baseline and 6-month follow up
Secondary	Tampa Scale of Kinesiophobia		baseline and 6-month follow up
Secondary	Pain Catastrophising Scale		baseline and 6-month follow up
Secondary	Patient Health Questionnaire 9		baseline and 6-month follow up
Secondary	Patients Global Impression of Change		6-month follow up