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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03109548
Enrollment
58
Registered
2017-04-12
Start date
2017-04-03
Completion date
2018-11-06
Last updated
2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Brief summary

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.

Interventions

OTHERStandard care initiated by the general practitioner

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

Sponsors

Research Unit for General Practice in Aalborg
CollaboratorOTHER
Aalborg University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Roland Morris Disability Questionnaire, RMDQ12 weeks follow-upChange 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

MeasureTime frameDescription
The Pain Catastrophizing ScaleBaseline, 12 weeks follow-upThe Pain Catastrophizing Scale (PCS) consists of 13 items focusing on thoughts and feelings in connection with pain.
Predicting the Inception of Chronic PainBaseline, 12 weeks follow-upThe 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).
Basic informationBaseline, 12 weeks follow-upA 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
The StarT Back Screening ToolBaseline, 12 weeks follow-upThe 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.
Cuff AlgometryBaseline, 12 weeks follow-upCuff algometry will be applied to assess pressure pain thresholds, temporal summation of pain and conditioned pain modulation.
Handheld AlgometryBaseline, 12 weeks follow-upHandheld algometry will be applied to assess pressure pain thresholds.
Assessment of the Pain AreaBaseline, 12 weeks follow-upPatients will be asked to draw the pain area of their low back pain on a body map.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026