Pain Management for Patients With Low Back Pain and Psychosocial Risk Factors in a Hospital Setting.
NCT ID: NCT03141541
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2017-04-01
2020-05-01
Brief Summary
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The purpose of the study is to investigate whether patients referred to secondary care with low back pain and coexisting psychosocial risk factors will have a better treatment outcome when participating in a pain management course in addition to usual care.
This will be investigated in a randomised study design, where 130 patients with chronic low back pain and psychosocial risk factors will be randomly allocated to either usual care or a cognitive-therapy based pain management intervention in addition to usual care.
The patients will be followed for one year after inclusion, and patientreported outcomes on disability, pain, sick leave, quality of life and pain coping will be collected by the use of questionnaires at baseline, 6 months and 12 months.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Furthermore, as outcomes are selfreported, masking of assessors is not possible, as the patients are the assessors.
Study Groups
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Usual care
All patients receive a thorough physical examination by a rheumatologist or a chiropractor with a subsequent examination by a physiotherapist.The patients receive general information about the nature back pain, adjustment of analgesic treatment and clarification of any need of further diagnosing or assessment by a surgeon. The physiotherapist furthermore makes an assessment of the patients' physical capacity and function and provides guidelines for any exercise programme. Based on the physiotherapist's judgement, the patient may be referred to rehabilitation in the local community
No interventions assigned to this group
Group based pain management intervention
In addition to usual care as described for the control group, the patients in the intervention group will participate in a cognitive group-based pain management intervention. The aim of the intervention is to improve the patients' understanding of their back pain problem, and that they learn different pain coping strategies. The intervention is based on cognitive behavioural therapy including elements of acceptance and commitment therapy, and furthermore uses different relaxation and breathing exercises.
Group based pain management intervention
The intervention is delivered as six separate sessions of each two hours duration over a four month period. The sessions are managed by a multidisciplinary team from the Spine Center, led by a psychologist. Before the first session, each patient in the intervention group participates in an individual consultation with the psychologist or nurse, with the aim of matching expectations for the group intervention, and hereby ensure the patients compliance throughout the intervention.
Interventions
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Group based pain management intervention
The intervention is delivered as six separate sessions of each two hours duration over a four month period. The sessions are managed by a multidisciplinary team from the Spine Center, led by a psychologist. Before the first session, each patient in the intervention group participates in an individual consultation with the psychologist or nurse, with the aim of matching expectations for the group intervention, and hereby ensure the patients compliance throughout the intervention.
Eligibility Criteria
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Inclusion Criteria
* Psychosocial risk profile defined as a fear avoidance score \>24 (Örebro Musculoskeletal Pain Questionnaire) and/or a bodily distress score \>15 (Common Mental Disorder Questionnaire) and/or health anxiety score \>9 (Common Mental Disorder Questionnaire)
* Speaks and understands Danish
* Age ≥ 18 years
Exclusion Criteria
* Spine surgery within the last year
* Untreated or severe depression
* Psychiatric course of treatment within the last year
* Abuse of drugs or alcohol
* Pregnancy
18 Years
ALL
No
Sponsors
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Central Jutland Regional Hospital
OTHER
Responsible Party
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Principal Investigators
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Nanna Rolving, PhD
Role: PRINCIPAL_INVESTIGATOR
Diagnostic Centre, Silkeborg Regional Hospital
Locations
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Diagnostic Centre, Regional Hospital Silkeborg
Silkeborg, , Denmark
Countries
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Other Identifiers
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6300005
Identifier Type: -
Identifier Source: org_study_id