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?

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Group based pain management intervention

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Silkeborg, Denmark, 8600
    • Diagnostic Centre, Regional Hospital Silkeborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; 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
Experimental: 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.	Behavioral: Group 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland Morris Disability Questionnaire	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).	Change from baseline to 12 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Back Pain Rating Scale - Back pain	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).	Change from baseline to 12 months after baseline
Low Back Pain Rating Scale - Leg pain	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).	Change from baseline to 12 months after baseline
EuroQol 5 Dimensions	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".	Change from baseline to 12 months after baseline
Pain Catastrophizing Scale	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).	Change from baseline to 12 months after baseline
Sick leave	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.	Change from baseline to 12 months after baseline

Collaborators and Investigators

• Sponsor: Central Jutland Regional Hospital
• Investigators: Principal Investigator: Nanna Rolving, PhD, Diagnostic Centre, Silkeborg Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: low back pain; randomised controlled trial; cognitive behavioural therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 6300005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available to other researchers when the study results have been published (anticipated 2020). The data will be available on request from the authors.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No