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

Study Overview
=================
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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Standard care initiated by the general practitioner


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Standard care initiated by the general practitioner|Patients are treated based on their symptoms and the research group does not interfere with this.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Morris Disability Questionnaire, RMDQ | 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. | 12 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The StarT Back Screening Tool | 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. | Baseline, 12 weeks follow-up | 
| The Pain Catastrophizing Scale | The Pain Catastrophizing Scale (PCS) consists of 13 items focusing on thoughts and feelings in connection with pain. | Baseline, 12 weeks follow-up | 
| Predicting the Inception of Chronic Pain | 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). | Baseline, 12 weeks follow-up | 
| Basic information | 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 | Baseline, 12 weeks follow-up | 
| Assessment of the Pain Area | Patients will be asked to draw the pain area of their low back pain on a body map. | Baseline, 12 weeks follow-up | 
| Cuff Algometry | Cuff algometry will be applied to assess pressure pain thresholds, temporal summation of pain and conditioned pain modulation. | Baseline, 12 weeks follow-up | 
| Handheld Algometry | Handheld algometry will be applied to assess pressure pain thresholds. | Baseline, 12 weeks follow-up |