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

NCT03141541 | Completed

• 1 other identifier: 6300005
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; cognitive behavioural therapy; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Low Back Pain Rating Scale - Back pain

  Change from baseline to 12 months after baseline

• Low Back Pain Rating Scale - Leg pain

  Change from baseline to 12 months after baseline

• EuroQol 5 Dimensions

  Change from baseline to 12 months after baseline

• Pain Catastrophizing Scale

  Change from baseline to 12 months after baseline

• Sick leave

  Change from baseline to 12 months after baseline

Study Arms (2)

Usual care

NO INTERVENTION

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

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

Interventions

Group based pain management intervention BEHAVIORAL

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.

Group based pain management intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead

Study Sites (1)

Diagnostic Centre, Regional Hospital Silkeborg

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nanna Rolving, PhD

  Diagnostic Centre, Silkeborg Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group randomised controlled trial

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: May 5, 2017
• Study Start: April 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 29, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)