Low Back Pain
Conditions
Keywords
low back pain, cognitive behavioural therapy, randomised controlled trial
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.
Interventions
BEHAVIORALGroup 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.
Sponsors
Central Jutland Regional Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The invistigator performing the data analysis is unaware of group allocation. Due to the study design (pain management intervention versus usual care) it is not possible to blind patients and care providers. Furthermore, as outcomes are selfreported, masking of assessors is not possible, as the patients are the assessors.
Intervention model description
Parallel group randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland Morris Disability Questionnaire | Change from baseline to 12 months after baseline | The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low Back Pain Rating Scale - Back pain | Change from baseline to 12 months after baseline | In the present study only the pain index of the LBPRS is used. The LBPRS pain index consists of two subscales, which measure back pain and leg pain, respectively. On each subscale the intensity of back pain and leg pain are reported on a 0-10 scale (best-worst) using the following three questions: the pain intensity at the time of examination, the average pain intensity within the past two weeks and the worst pain experienced within the past two weeks. The score of each subscale are reported separately (0-10 scale). |
| Low Back Pain Rating Scale - Leg pain | Change from baseline to 12 months after baseline | In the present study only the pain index of the LBPRS is used. The LBPRS pain index consists of two subscales, which measure back pain and leg pain, respectively. On each subscale the intensity of back pain and leg pain are reported on a 0-10 scale (best-worst) using the following three questions: the pain intensity at the time of examination, the average pain intensity within the past two weeks and the worst pain experienced within the past two weeks. The score of each subscale are reported separately (0-10 scale). |
| EuroQol 5 Dimensions | Change from baseline to 12 months after baseline | The EQ-5D is a measure of generic quality of life. It comprises five dimensions, which are mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels (no problem, some problems, extreme problems) resulting in a total of 245 potential health states. The scores fall on a scale of -0.624 to 1.000 (perfect health) including the scores of -0.293 for unconscious and 0.000 for dead. |
| Pain Catastrophizing Scale | Change from baseline to 12 months after baseline | The PCS measures an individual's pain experience through 13 questions asking about how one feels and what he/she thinks about when in pain. The PCS evaluates pain catastrophizing as a single construct with three components: rumination, magnification, and helplessness. Each question is answered on a 0-4 scale (best worst), adding up to a total score of 0-52 (best-worst). |
| Sick leave | Change from baseline to 12 months after baseline | The patients report their average weekly sick leave during the past 4 weeks in the three categories 0 days per week, 1-4 days per week, 5-7 days per week, all the time. |
Countries
Denmark
Outcome results
None listed