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Evaluation of a risk tailored intervention among low back pain patients in primary care

Evaluation of a risk tailored intervention among low back pain patients in primary care: a cluster randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68205910
Enrollment
1200
Registered
2009-05-29
Start date
2009-03-16
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Low back pain without specific origin Musculoskeletal Diseases Dorsalgia

Interventions

The intervention consists of two elements: 1. A risk-factor screening and risk tailored educational intervention including information and counselling 2. A telephone/email consulting service concernin

Sponsors

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: General Practitioners (GPs) in Göttingen and within 20 minutes driving distance of the study centre and Berlin (less than 15 km distance from the study centre) are invited to take part in the trial by letter. Addresses were obtained from the local health boards. In case of non-response to the letter, GPs are contacted by telephone or personally. The GPs recruit patients according to the following inclusion criteria: 1. Men and women aged 20 - 60 years 2. Consultation for low back pain 3. Written informed consent

Exclusion criteria

Exclusion criteria: Patient: 1. Severe comorbidities (e.g. congestive heart failure, tumour) 2. Back pain of specific origin 3. Insufficient German language proficiency 4. Ongoing juridical proceedings due to pension claims 5. Prior spine surgery 6. Ongoing specialised pain treatment 7. Rehabilitation because of back pain in the past five years

Design outcomes

Primary

MeasureTime frame
1. Functional disability as measured with the Hanover Functional Ability Questionnaire 2. Days of sick leave (over a 3-month recall period)

Secondary

MeasureTime frame
Patients' characteristics as measured by a questionnaire: 1. Graded chronic pain (Graded Chronic Pain Scale [GCPS]) 2. Depression (Patient Health Questionnaire, German version [PHQ-D]) 3. Quality of life (PHQ-D, 12-item short form [SF-12]) 4. Fear Avoidance Beliefs Questionnaire (FABQ) 5. Physical activity 6. Catastrophising (Fatigue Severity Scale [FSS]) 7. Health services utilisation All measures will be assessed at baseline and, 6 and 12 months after inclusion in the study. Additionally, participation in the counselling groups and telephone/email contacts will be documented.

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026