Disease Perception and Recovery From Low Back Pain

Low Back Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058315
• Other study ID #: 6300004
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2018
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 828
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• 18 years or older

Exclusion Criteria:

• Spinal fractures

• Malignancy

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Denmark	Diagnostic Centre, Regional Hospital Silkeborg	Silkeborg

Sponsors (2)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital	Aalborg University

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View Citation

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. — View Citation

Glasziou P, Haynes B. The paths from research to improved health outcomes. Evid Based Nurs. 2005 Apr;8(2):36-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Major Depression Inventory (depression)	Validated questionnaire containing 10 questions regarding symptoms of depression	Change from baseline to 52 weeks