PACE Plus trial

Suspended

Conditions: Acute low back pain

Registration Number: NL-OMON26717

Lead Sponsor: Erasmus MC, department of General Practice

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 800

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

- Patients with acute non-specific low back pain presenting in general practice;

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

- Have known or suspected serious spinal pathology (e.g. metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome, spinal fracture);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ow back pain intensity measured daily with an 11-point numerical scale (higher score means more pain).

Secondary Outcome Measures

Name	Time	Method
- Disability (Roland Morris Disability Questionnaire)<br /><br>- Patients’ perceived recovery (7-point Likert scale dichotomized into recovered (score 1 ‘complete recovery’ and 2 ‘much improved) and not-recovered (score 3 ‘improvement’ to score 7 ‘worse than ever’))<br /><br>- Quality of life (EuroQol-5D) <br /><br>- Costs (iMedical Consumption Questionnaire (iMCQ) and iProductivity Cost Questionnaire (iPCQ)) <br /><br>- Time to recovery (pain diary)<br /><br>- Compliance to treatment (digital diary derived from the Brief Medication Questionnaire) <br /><br>- Adverse reactions<br /><br>- Patients’ satisfaction (11-point numerical rating scale; higher score means more satisfaction).<br /><br>- Sleep quality (4 point Likert scale derived from the Pittsburgh Sleep Quality Index (PSQI); scores dichotomized into good sleep quality (score 1 ‘very good’ and 2 ‘fairly good’) and poor sleep quality (score 3 ‘fairly bad’ and 4 ‘very bad’))<br /><br>- Co-interventions