The patient education booklet as part of low back pain (LBP) care in primary care compared with best current care.

A cluster randomized clinical trial of the use of the patient education booklet as part of low back pain (LBP) care in primary care compared with best current care.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14389368

Enrollment

268

Registered

2019-05-13

Start date

2017-04-13

Completion date

Unknown

Last updated

2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low back pain Musculoskeletal Diseases

Interventions

The intervention is a short 30 min education training session for physiotherapists and physicians containing the main themes and theory of the new patient education booklet. The booklet is provided fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18-65 years of age 2. LBP with or without radicular pain

Exclusion criteria

Exclusion criteria: 1. First patient-reported contact to health care due to LBP and episode has lasted less than 2 weeks 2. A suspicion of a serious cause for LBP or LBP requiring urgent care.

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 30/10/2019: 1. Change in PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) from baseline to 3-month follow-up. 2. The proportion of patients presenting with LBP who receive imaging examinations due to LBP over the first three months of follow-up. Previous primary outcome measure: 1. Change in Oswestry disability index (ODI) from baseline to the 12-month follow-up 2. Number of imaging examinations due LBP over the 3-month follow up.	—

Measure

Time frame

Current primary outcome measure as of 30/10/2019: 1. Change in PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) from baseline to 3-month follow-up. 2. The proportion of patients presenting with LBP who receive imaging examinations due to LBP over the first three months of follow-up. Previous primary outcome measure: 1. Change in Oswestry disability index (ODI) from baseline to the 12-month follow-up 2. Number of imaging examinations due LBP over the 3-month follow up.

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Secondary

Measure	Time frame
1. Pain and disability: Oswestry disability Index, change from baseline to 12-month follow-up 2. Roland Morris disability questionnaire change from baseline to 12-month follow-up 3. PROMIS (Patient-Reported Outcomes Measurement Information System) (short form 20a) change from baseline to 3- and 12-month follow-ups 4. Frequency of LBP during past 3 months change from baseline to 3- and 12-month follow-ups 5. LBP intensity (NRS) during past week change from baseline to 3- and 12-month follow-ups 6. Leg pain intensity (NRS) during past week change from baseline to 3- and 12-month follow-ups 7. SBST (STarT Back screening tool) change from baseline to 12-month follow-up. 8. Health-related quality of life: EQ-5D (EuroQol five dimensions) change from baseline to 12-month follow-up. 9. Direct costs: 9.1 Physician visit during past year 9.2 Physiotherapist visits during past year 9.3 Nurse visits during past year 9.4 Other health care professional visits (e.g. psychologist) during past year 9.5 Imaging due to LBP (x-ray/MRI/CT) during past year 9.6 Pain medication over the first year and 3 years 9.7 Back operation and other invasive procedures. 10. Indirect costs: 10.1 Days on sick leave during past year (LBP-related and All) 10.2 Disability pensions over the first year and at 3 years.	—

Measure

Time frame

1. Pain and disability: Oswestry disability Index, change from baseline to 12-month follow-up 2. Roland Morris disability questionnaire change from baseline to 12-month follow-up 3. PROMIS (Patient-Reported Outcomes Measurement Information System) (short form 20a) change from baseline to 3- and 12-month follow-ups 4. Frequency of LBP during past 3 months change from baseline to 3- and 12-month follow-ups 5. LBP intensity (NRS) during past week change from baseline to 3- and 12-month follow-ups 6. Leg pain intensity (NRS) during past week change from baseline to 3- and 12-month follow-ups 7. SBST (STarT Back screening tool) change from baseline to 12-month follow-up. 8. Health-related quality of life: EQ-5D (EuroQol five dimensions) change from baseline to 12-month follow-up. 9. Direct costs: 9.1 Physician visit during past year 9.2 Physiotherapist visits during past year 9.3 Nurse visits during past year 9.4 Other health care professional visits (e.g. psychologist) during past year 9.5 Imaging due to LBP (x-ray/MRI/CT) during past year 9.6 Pain medication over the first year and 3 years 9.7 Back operation and other invasive procedures. 10. Indirect costs: 10.1 Days on sick leave during past year (LBP-related and All) 10.2 Disability pensions over the first year and at 3 years.

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Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026