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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: no intervention

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 A participant may be withdrawn by the investigators, involved in major trauma or undergoes surgery, or a female participant becomes pregnant during the course of the study.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

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Nottingham University Hospitals NHS Trust
    • Nottingham, Nottinghamshire, United Kingdom, NG1 6GN
      • Nottingham CityCare Partnership

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include community ambulant adult patients attending or recently attended outpatient physiotherapy treatment for their chronic low back pain.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Paul Hendrick, PhD, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: chronic pain; low back pain; self-management; longitudinal study; predictive modelling
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 15084; 188664 (Other Identifier: IRAS Project ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO