NCT03058315

Brief Summary

The main purpose of the study is to investigate the importance of patients' beliefs regarding staying active despite low back pain, among patients referred from general practice to secondary care treatment in Denmark. It is hypothesised that patients believing that staying active will help them recover will have higher odds of a 30%-improvement in The Roland Morris Disability score after 52 weeks compared to patients disagreeing that staying active will lead to better recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
828

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 9, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 13, 2019

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

February 9, 2017

Last Update Submit

May 10, 2019

Conditions

Low Back Pain

Keywords

Physical activityDisease perceptionPain beliefsDisabilityAdvice

Outcome Measures

Primary Outcomes (1)

  • Change in Rolland Morris Disability Questionnaire

    Validated questionnaire containing 23 questions on self-reported disability due to low back pain

    Change from baseline to 52 weeks

Secondary Outcomes (5)

  • Change in Low Back Pain Rating Scale

    Change from baseline to 52 weeks

  • Change in EuroQol 5 Dimensions (quality of life)

    Change from baseline to 52 weeks

  • Change in proportion on sick leave

    Change in proportion of patients on sick leave from baseline to 52 weeks

  • Received consultations in primary sector after referral to secondary care

    Measured at 52 week follow-up

  • Change in Major Depression Inventory (depression)

    Change from baseline to 52 weeks

Study Arms (1)

Low back pain patients

Cohort of 800 consecutive low back pain patients, 18 years +, who have been referred from general practice to the secondary sector for further examination and MR scan.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of 800 consecutive low back pain patients referred from primary care to the Spine Centre at Silkeborg Regional Hospital.

You may qualify if:

  • Low back pain (with or without sciatica) as the dominant musculoskeletal complaint
  • years or older

You may not qualify if:

  • Spinal fractures
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diagnostic Centre, Regional Hospital Silkeborg

Silkeborg, 8600, Denmark

Location

Related Publications (5)

  • Bishop A, Foster NE, Thomas E, Hay EM. How does the self-reported clinical management of patients with low back pain relate to the attitudes and beliefs of health care practitioners? A survey of UK general practitioners and physiotherapists. Pain. 2008 Mar;135(1-2):187-95. doi: 10.1016/j.pain.2007.11.010.

    PMID: 18206309BACKGROUND

  • Dima A, Lewith GT, Little P, Moss-Morris R, Foster NE, Bishop FL. Identifying patients' beliefs about treatments for chronic low back pain in primary care: a focus group study. Br J Gen Pract. 2013 Jul;63(612):e490-8. doi: 10.3399/bjgp13X669211.

    PMID: 23834886BACKGROUND

  • Glasziou P, Haynes B. The paths from research to improved health outcomes. Evid Based Nurs. 2005 Apr;8(2):36-8. doi: 10.1136/ebn.8.2.36. No abstract available.

    PMID: 15830412BACKGROUND

  • Udby CL, Riis A, Thomsen JL, Rolving N. Does the use of telephone reminders to increase survey response rates affect outcome estimates? An ancillary analysis of a prospective cohort study of patients with low back pain. BMC Musculoskelet Disord. 2021 Oct 20;22(1):893. doi: 10.1186/s12891-021-04787-4.

    PMID: 34670521DERIVED

  • Riis A, Karran EL, Thomsen JL, Jorgensen A, Holst S, Rolving N. The association between believing staying active is beneficial and achieving a clinically relevant functional improvement after 52 weeks: a prospective cohort study of patients with chronic low back pain in secondary care. BMC Musculoskelet Disord. 2020 Jan 20;21(1):47. doi: 10.1186/s12891-020-3062-6.

    PMID: 31959168DERIVED

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Nanna Rolving, PhD

    Diagnostic Centre, Silkeborg Regional Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 20, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

May 13, 2019

Record last verified: 2018-04

Locations

DK(1)