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Low Back PainNCT02636777

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

An observational study of Low Back Pain, run by University of Nottingham at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain
How many people
270 participants
Where
2 sitesUnited Kingdom
Study dates
Dec 2015to Feb 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Nottingham CityCare Partnership

    Nottingham, Nottinghamshire, NG1 6GN

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire, NG7 2UH

Other trials in United Kingdom

About this study

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.

Read the 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
Being tested
no intervention
Keywords
low back pain, chronic pain, self-management, longitudinal study, predictive modelling
Medical subject headings
Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Health Education Impact Questionnaire

    Measured: baseline and 6-month follow up

Secondary outcomes (8)

  1. Duration of low back pain

    Measured: baseline

  2. Numeric Pain Intensity Scale

    Measured: baseline and 6-month follow up

  3. Roland Morris Disability Questionnaire

    Measured: baseline and 6-month follow up

  4. International Physical Activity Questionnaire (Short Form)

    Measured: baseline and 6-month follow up

  5. Tampa Scale of Kinesiophobia

    Measured: baseline and 6-month follow up

  6. Pain Catastrophising Scale

    Measured: baseline and 6-month follow up

  7. Patient Health Questionnaire 9

    Measured: baseline and 6-month follow up

  8. Patients Global Impression of Change

    Measured: 6-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02636777
Sponsor's protocol ID
15084
Other IDs
188664
Status last verified
Jun 2018
First submitted
15 Dec 2015
Last updated
21 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36476492

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by University of Nottingham at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Health Education Impact Questionnaire (time frame: baseline and 6-month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02636777, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.

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