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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109548
• Other study ID #: N-20160086
• Status: Completed
• Start date: April 3, 2017
• Est. completion date: November 6, 2018

Study information

• Verified date: May 2019
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Denmark	Lægerne Sløjfen	Aalborg	Aalborg East

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Research Unit of General Practice, Aalborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Handheld Algometry	Handheld algometry will be applied to assess pressure pain thresholds.	Baseline, 12 weeks follow-up