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

NCT ID: NCT02636777

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-02-28

Brief 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.

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 A participant may be withdrawn by the investigators, involved in major trauma or undergoes surgery, or a female participant becomes pregnant during the course of the study.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

Conditions

Low Back Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

no intervention

Patients will be allowed to continue their usual treatment as recommended by their care team.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Hendrick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Nottingham CityCare Partnership

Nottingham, Nottinghamshire, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Countries

United Kingdom

References

Banerjee A, Hendrick P, Blake H. Predictors of self-management in patients with chronic low back pain: a longitudinal study. BMC Musculoskelet Disord. 2022 Dec 7;23(1):1071. doi: 10.1186/s12891-022-05933-2.

Reference Type: DERIVED

PMID: 36476492 (View on PubMed)

Other Identifiers

188664

Identifier Type: OTHER

Identifier Source: secondary_id

15084

Identifier Type: -

Identifier Source: org_study_id