NCT02636777

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

December 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

2.2 years

First QC Date

December 15, 2015

Last Update Submit

June 20, 2018

Conditions

Low Back Pain

Keywords

low back painchronic painself-managementlongitudinal studypredictive modelling

Outcome Measures

Primary Outcomes (1)

  • Change in Health Education Impact Questionnaire

    baseline and 6-month follow up

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

no interventionOTHER

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nottingham CityCare Partnership

Nottingham, Nottinghamshire, NG1 6GN, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 36476492DERIVED

MeSH Terms

Conditions

Low Back PainChronic Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Hendrick, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 22, 2015

Study Start

December 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)