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

Completed

• Conditions: Low Back Pain

• Registration Number: NCT03109548
• Lead Sponsor: Aalborg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-31
• Study Start: 2017-04-03
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-12
• Primary Completion: 2018-11-06
• Study Completion: 2018-11-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Roland Morris Disability Questionnaire, RMDQ	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 Outcome Measures

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

Trial Locations

Locations (1)

Lægerne Sløjfen; 🇩🇰 Aalborg, Aalborg East, Denmark