Clinical Trials Directory

Trials / Completed

CompletedNCT03141541

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

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?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
130 (actual)
Sponsor
Central Jutland Regional Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGroup based pain management interventionThe 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.

Timeline

Start date
2017-04-01
Primary completion
2020-03-01
Completion
2020-05-01
First posted
2017-05-05
Last updated
2020-10-29

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT03141541. Inclusion in this directory is not an endorsement.