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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Standard care initiated by the general practitioner

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Denmark
  • Aalborg East
    • Aalborg, Aalborg East, Denmark, 9220
      • Lægerne Sløjfen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subjects will be recruited through general practitioners in The North Denmark Region. When a patient with low back pain reports to his/her general practitioner, the doctor will present the project to the patient, and in case the patient shows interest, the doctor asks him/her to contact the contact person of the study. Thus, the recruitment does not take place through advertisements, but through the normal patient flow in the general practice.

Description

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 Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Research Unit of General Practice, Aalborg
• Investigators: Principal Investigator: Martin B Jensen, MD, PhD, Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): November 6, 2018
• Study Completion (Actual): November 6, 2018

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: N-20160086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No