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Low Back PainNCT03058315

Disease Perception and Recovery From Low Back Pain

An observational study of Low Back Pain, run by Central Jutland Regional Hospital at 1 site in Denmark.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain
How many people
828 participants
Where
1 siteDenmark
Study dates
1 Apr 2017to 1 Apr 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Spinal fractures
  • Malignancy

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Diagnostic Centre, Regional Hospital Silkeborg

    Silkeborg, 8600

Other trials in Denmark

About this study

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.

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.

Read the 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.

Conditions
Low Back Pain
Keywords
Physical activity, Disease perception, Pain beliefs, Disability, Advice
Medical subject headings
Low Back Pain, Motor Activity

What participants receive

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

Study groups in NCT03058315
Study groupRoleWhat they receive
Low back pain patientsCohort 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 being measured

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

  1. Change in Rolland Morris Disability Questionnaire

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

    Measured: Change from baseline to 52 weeks

Secondary outcomes (5)

  1. Change in Low Back Pain Rating Scale

    Validated questionnaire containing 6 questions on self-reported back and leg pain intensity

    Measured: Change from baseline to 52 weeks

  2. Change in EuroQol 5 Dimensions (quality of life)

    Validated questionnaire containing 5 questions on self-reported generic quality of life

    Measured: Change from baseline to 52 weeks

  3. Change in proportion on sick leave

    Self-reported average weekly sick leave during the past 4 weeks

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

  4. 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: Measured at 52 week follow-up

  5. Change in Major Depression Inventory (depression)

    Validated questionnaire containing 10 questions regarding symptoms of depression

    Measured: Change from baseline to 52 weeks

Timeline

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

  1. First posted20 Feb 2017
  2. Study start1 Apr 2017
  3. Primary completion1 Apr 2019
  4. Study completion1 Apr 2019

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
Cohort
Time perspective
Prospective
Enrolment
828 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03058315
Sponsor's protocol ID
6300004
Status last verified
Apr 2018
First submitted
9 Feb 2017
Last updated
13 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 18206309

  • 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.

    PubMed 23834886

  • 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.

    PubMed 15830412

  • 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.

    PubMed 34670521

  • 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.

    PubMed 31959168

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by Central Jutland Regional Hospital at 1 site in Denmark.

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 2 inclusion and 2 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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 Rolland Morris Disability Questionnaire (time frame: Change from baseline to 52 weeks). 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 NCT03058315, which also lists 5 linked publications.

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 13 May 2019.

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