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

NCT03109548 | Completed DMC

• 1 other identifier: N-20160086
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The StarT Back Screening Tool

  Baseline, 12 weeks follow-up

• The Pain Catastrophizing Scale

  Baseline, 12 weeks follow-up

• Predicting the Inception of Chronic Pain

  Baseline, 12 weeks follow-up

• Basic information

  Baseline, 12 weeks follow-up

• Assessment of the Pain Area

  Baseline, 12 weeks follow-up

Interventions

Standard care initiated by the general practitioner OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with low back pain, who have a mobile phone.

You may not qualify if:

• Pregnancy
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Alcohol addiction
• Lack of ability to cooperate
• Surgery to the spine

Sponsors & Collaborators

• Aalborg University: lead
• Research Unit for General Practice in Aalborg: collaborator

Study Sites (1)

Lægerne Sløjfen

Aalborg, Aalborg East, 9220, Denmark

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin B Jensen, MD, PhD

  Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 12, 2017
• Study Start: April 3, 2017
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)