Clinical trial NCT03141541: Pain Management for Patients With Low Back Pain and Psychosocial Risk Factors in a Hospital Setting.
Official title: Does a Patient Education Focused on Pain Management Improve Disability, Pain Coping and Quality of Life in Patients With Low Back Pain and Psychosocial Risk Factors?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
cognitive behavioural therapy
randomised controlled trial
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Patients with low back pain and coexisting psychosocial risk factors have a poorer prognosis in terms of quality of life, disability, sick leave and health care use. Despite existing literature showing that low back pain patients benefit from cognitive therapy interventions, this has not been investigated in subgroups of low back pain patients with psychosocial risk factors.

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.


Eligibility criteria: Inclusion Criteria:

* Non-specifick low back pain lasting ≥ 3 months
* 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:

* Inflammatory or malignant disease
* Spine surgery within the last year
* Untreated or severe depression
* Psychiatric course of treatment within the last year
* Abuse of drugs or alcohol
* Pregnancy

Primary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: Change from baseline to 12 months after baseline
Secondary outcomes:
measure: Low Back Pain Rating Scale - Back pain
timeFrame: Change from baseline to 12 months after baseline
measure: Low Back Pain Rating Scale - Leg pain
timeFrame: Change from baseline to 12 months after baseline
measure: EuroQol 5 Dimensions
timeFrame: Change from baseline to 12 months after baseline
measure: Pain Catastrophizing Scale
timeFrame: Change from baseline to 12 months after baseline
measure: Sick leave
timeFrame: Change from baseline to 12 months after baseline
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Diagnostic Centre, Regional Hospital Silkeborg
Study officials:
affiliation: Diagnostic Centre, Silkeborg Regional Hospital
name: Nanna Rolving, PhD
role: PRINCIPAL_INVESTIGATOR
References: