Disease Perception and Recovery From Low Back Pain

A Prospective Cohort Study With 52 Weeks Follow-up Investigating the Influence of Disease Perception on Functional Outcome Among Patients Referred From General Practice to Secondary Care for Treatment of Low Back Pain.

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain

Detailed Description

Background: According to international guidelines on low back pain (LBP), advice to stay active should be provided from healthcare professionals to all patients with LBP. However, provision of advice to stay active is reported to be diverse. Some primary care healthcare professionals believe that avoidance of activities and work will help the patient recover. Consequently some patients are not receiving optimal advice to stay active and may think that inactivity will help them and consequently achieve less favourable treatment outcomes. Thus, changing patients' beliefs are considered the key decisive factor to change actual behaviour, and by that improve the functional ability of the patients. This should reduce primary health care use and reduce referrals to the more expensive treatments in secondary care. The effect of patients' beliefs on their functional outcomes has to our knowledge never been studied in a population of patients with LBP being referred from primary care to secondary care treatment.

Materials and Methods:

This is a prospective cohort study. Data is collected from a consecutive series of 800 adult patients (18+), with low back pain as the dominant musculoskeletal complaint, referred from general practices in Central Denmark Region to the Spine Centre at Silkeborg Regional Hospital. Patients will be excluded in case of spinal fractures or malignancy.

All patients seen at the Spine Centre receive a digital letter with a link to an online questionnaire to be completed approximately one week before their appointment at the Spine Centre. The questionnaire contains questions about their back pain history, present pain (Low Back Pain Rating Scale), disability (Rolland Morris Disability Questionnaire), quality of life (EQ-5D), fear-avoidance questions (Örebro Musculoskeletal Pain Questionnaire), STarT Back Screening tool, questions on average level of physical activity, beliefs about physical activity in relation to back pain, advice received from health professionals about staying active, and questions about employment and housing situation. For those accepting participation the same questionnaire is forwarded by email 52 weeks after the initial visit at the Spine Center.

Expected outcome and perspective: This study will bring knowledge about the associations between patient's disease perceptions and beliefs about staying active despite pain and their functional improvement. Furthermore, the study will clarify to what extent patients perceive to have been given advice to stay active by a primary care health professional. Although this study does not explain why some patients do not have guideline concordant beliefs, it will help inform health care professionals in primary care about the possible potential of an increased primary care attention towards the recommendation of staying active when patients have LBP.

• Study Type: Observational
• Enrollment (Actual): 828

Contacts and Locations

Study Locations

• Denmark
  • Silkeborg, Denmark, 8600
    • Diagnostic Centre, Regional Hospital Silkeborg

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Spinal fractures
• Malignancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Low Back Pain Rating Scale	Validated questionnaire containing 6 questions on self-reported back and leg pain intensity	Change from baseline to 52 weeks
Change in EuroQol 5 Dimensions (quality of life)	Validated questionnaire containing 5 questions on self-reported generic quality of life	Change from baseline to 52 weeks
Change in proportion on sick leave	Self-reported average weekly sick leave during the past 4 weeks	Change in proportion of patients on sick leave from baseline to 52 weeks
Received consultations in primary sector after referral to secondary care	Any consultations with GP, physiotherapist or chiropractors in the year following referral to secondary care due to low back pain (YES/NO)	Measured at 52 week follow-up
Change in Major Depression Inventory (depression)	Validated questionnaire containing 10 questions regarding symptoms of depression	Change from baseline to 52 weeks

Collaborators and Investigators

• Sponsor: Central Jutland Regional Hospital
• Collaborators: Aalborg University
• Investigators: Principal Investigator: Nanna Rolving, PhD, Diagnostic Centre, Silkeborg Regional Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Physical activity; Disability; Pain beliefs; Advice; Disease perception
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 6300004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No