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Completed

NCT Number: NCT03109548

Pre-treatment Factors for the Development of Chronic Pain in Low Back Pain Patients

The purpose of the project is to associate pre-treatment pain sensitivity level, levels of pain catastrophizing and levels of The Subgroups for Targeted Treatment (STarT) Back Screening Tool in patients with acute low back pain and patients' progression after 12 weeks of treatment by general practitioners.

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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–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lægerne Sløjfen

Aalborg, Aalborg East, 9220, Denmark

Who can participate

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

Inclusion criteria

  • Patients with low back pain, who have a mobile phone.

Exclusion criteria

  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Alcohol addiction
  • Lack of ability to cooperate
  • Surgery to the spine

Treatment and study plan

Standard care initiated by the general practitioner

Other

Patients are treated based on their symptoms and the research group does not interfere with this.

Primary outcomes

  1. Roland Morris Disability Questionnaire, RMDQ

    Time frame: 12 weeks follow-up

    Change in the Roland-Morris Questionnaire (RMDQ) is one of the most widely used questionnaires for back pain. The RMDQ is a self-administered disability questionnaire consisting of 24 questions. The questions are related specifically to physical functions likely to be affected by low back pain. Each item is qualified with the phrase "because of my back pain" to distinguish back pain disability from disability due to other causes. When completing the RMDQ, the respondents are asked to tick a statement if it applies to them on that particular day.

Secondary outcomes

  1. The StarT Back Screening Tool

    Time frame: Baseline, 12 weeks follow-up

    The The StarT Back Screening Tool (SBST) is a nine-item patient self-reporting questionnaire validated for triage of nonspecific low back pain patients in primary care.

  2. The Pain Catastrophizing Scale

    Time frame: Baseline, 12 weeks follow-up

    The Pain Catastrophizing Scale (PCS) consists of 13 items focusing on thoughts and feelings in connection with pain.

  3. Predicting the Inception of Chronic Pain

    Time frame: Baseline, 12 weeks follow-up

    The Predicting the Inception of Chronic Pain (PICKUP) questionnaire focuses on pain ("How much low back pain have you had during the past week?", 1 = none, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe, 6 = very severe), radiating pain to the legs ("Do you have leg pain?" 0 = no, 1 = yes), compensability ("Is your back pain compensable, e.g. through worker's compensation or third party insurance?" 0 = no, 1 = yes), depression ("How much have you been bothered by feeling depressed in the past week (0-10 scale)?" 0 = not at all, 10 = extremely) and the subject's overall evaluation of the risk of chronic pain ("In your view, how large is the risk that your current pain may become persistent (0-10 scale)?" 0 = none, 10 = extreme).

  4. Basic information

    Time frame: Baseline, 12 weeks follow-up

    A general questionnaire has been created for this study to gain a basic understanding of the patient's current pain, demographic information and use of medication

  5. Assessment of the Pain Area

    Time frame: Baseline, 12 weeks follow-up

    Patients will be asked to draw the pain area of their low back pain on a body map.

  6. Cuff Algometry

    Time frame: Baseline, 12 weeks follow-up

    Cuff algometry will be applied to assess pressure pain thresholds, temporal summation of pain and conditioned pain modulation.

  7. Handheld Algometry

    Time frame: Baseline, 12 weeks follow-up

    Handheld algometry will be applied to assess pressure pain thresholds.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Research Unit for General Practice in Aalborg

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
May 10, 2019

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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