Pain Management for Patients With Low Back Pain and Psychosocial Risk Factors in a Hospital Setting.
- Conditions
- Low Back Pain
- Interventions
- Behavioral: Group based pain management intervention
- Registration Number
- NCT03141541
- Lead Sponsor
- Central Jutland Regional Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group based pain management intervention 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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".
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).
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.
Trial Locations
- Locations (1)
Diagnostic Centre, Regional Hospital Silkeborg
🇩🇰Silkeborg, Denmark