Pain Management for Patients With Low Back Pain and Psychosocial Risk Factors in a Hospital Setting.

Central Jutland Regional Hospital

Status: Completed

Conditions: Low Back Pain

Treatments: Behavioral: Group based pain management intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03141541

6300005

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Usual care

No Intervention group

Description:

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

Group based pain management intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Group based pain management intervention