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Completed

NCT Number: NCT03141541

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diagnostic Centre, Regional Hospital Silkeborg

Silkeborg, 8600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Roland Morris Disability Questionnaire

    Time frame: 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 outcomes

  1. Low Back Pain Rating Scale - Back pain

    Time frame: 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).

  2. Low Back Pain Rating Scale - Leg pain

    Time frame: 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).

  3. EuroQol 5 Dimensions

    Time frame: 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".

  4. Pain Catastrophizing Scale

    Time frame: 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).

  5. Sick leave

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Central Jutland Regional Hospital

Other

Registry information

Official study title

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?

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 5, 2017
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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